RU2766973C1 - Method for combination therapy for rosacea of erithematous-teleangectatic subtype - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to dermatology and cosmetology, and can be used for the treatment of rosacea of ​​the erythematous-telangectatic subtype. Then 0.5% brimonidine tartrate gel is applied to the affected skin daily, once a day, in the morning, for 3 months. The drug is applied to the affected areas: forehead, cheeks, nose and chin. Procedures of broadband pulsed light radiation with a wavelength range of 500-1200 nm are carried out on a multi-module platform M22 using an IPL (Intensive pulse light) nozzle, and the procedures are carried out 1 time in 28-30 days, a course of 3 procedures. After the procedure is completed, patients are applied photoprotectors with a protection factor of 50 to the affected areas.

EFFECT: method provides an increase in the period of remission, reduces the duration of treatment and reduces the likelihood of side effects due to the combination of broadband pulsed light radiation with topical application of brimonidine tartrate.

1 cl, 3 dwg, 1 tbl, 3 ex

Description

The technical field to which the invention belongs

The invention relates to medicine, namely to dermatology, and can be used for the treatment of mild and moderate forms of erythematous-telangectatic subtype of rosacea.

State of the art

Rosacea is one of the most complex dermatoses, as it is a multifactorial, chronic relapsing disease that is torpid to treatment and is characterized by lesions of the facial skin in the form of erythema, telangectasias and papulo-pustular elements. In recent years, the development of the disease has been associated with changes in the immune system [Kellen R., Silverberg N.B, 2016]. Rosacea is observed in people of both sexes aged 30 to 50 years [Chosidow O., Cribier B., 2011], but it is more common in women with a certain genetic predisposition to transient reddening of the skin of the face, less often in the neck and décolleté [Arabian E .A., Samtsov A.V., 2015]. The development of dermatosis is more often observed in persons of phototypes 1 and 2, the so-called “Celtic hot flashes”, however, the disease can occur with any skin phototype [Arabiiskaya E.A., Samtsov A.V. 2015; Wilkin J., 2002]. The incidence is 165 per 100 thousand population per year, and the prevalence varies depending on the country and can range from 1 to 22% [Weinkle A.P., Doktor V., Emer J, 2015]. Thus, in European countries, the incidence of rosacea averages from 1.5% to 10%, in Russia (RISE, 2015) 5% [Araviyskaya E.A., Samtsov A.V., 2015; Tan J., Schofer H., 2015].

The main features of erythematous-telangectatic rosacea are persistent central facial erythema (background erythema) and the progressive appearance of telangiectasias on the skin of the face [Barabanov LG, 2009; Kurdina M.I., 1998; Jansen T., 2008].

On the territory of the Russian Federation, for the treatment of rosacea, medications are used that are approved by clinical guidelines developed by the Russian Society of Dermatovenereologists and Cosmetologists in 2020.

For the treatment of mild and moderate forms of erythematous-telangectatic subtype of rosacea, in accordance with clinical guidelines, it is recommended to use local agents: metronidazole, gel 0.75%, cream 1%; brimonidine tartrate, gel 0.5%; azelaic acid, cream 15%. Physiotherapeutic treatment is also shown: sources of incoherent intense light radiation (IPL), however, protocols for the combined use of external and physiotherapy are not given.

Thus, the treatment of patients with erythematous-telangectatic rosacea is a difficult task, due to the localization of the process, low adherence of patients to treatment, a variety of etiological and pathogenetic factors leading to recurrence of dermatosis. In modern conditions, it is necessary to develop complex effective methods of treatment with the achievement of a stable clinical effect in a shorter time.

Currently, some methods of treating rosacea are known, published in patent descriptions, articles in journals, monographs, textbooks.

For example, a number of authors have developed approaches to the pathogenetic therapy of the erythematous-telangectatic subtype of rosacea with the effective use of photo- and laser therapy in treatment [Kawana S. et. al., 2007; Galkina O.A., 2007; Kovalchuk L.A. et al., 2012; Kruglova L.S. et al., 2014; Papageorgiou P. et. al., 2008].

Also known is the treatment of erythema rosacea with alpha-2-adrenergic receptor agonists according to patents for inventions (US 2006/0171974 A1, IPC 2006.01: A61K 31/498, 08/03/2006; US 2005/0165079 A1, IPC A61K 31/4164, published July 28, 2005).

These types of treatment have side effects that are unpleasant for the patient, such as burning sensation, itching and dryness of the skin of the face, or increased erythema. In addition, the above treatments have a long duration of therapy, a short remission period, and thus do not always provide effective treatment for the erythematous-telangectatic subtype of rosacea.

The closest analogues to the proposed invention include clinical studies and evidence of the effectiveness and safety of using each of the methods separately - broadband pulsed light radiation and topical application of 0.5% brimonidine tartrate gel in the treatment of patients with erythematous-telangiectatic subtype of rosacea, published in the British Journal of Dermatology (Fowler J, Jarratt M, Moore A, Meadows K, Pollack A, Steinhoff M, Liu Y, Leoni M. Brimonidine Phase II Study Group. Once-daily topical brimonidine tartrate gel 0.5% is a novel treatment for moderate to severe facial erythema of rosacea: results of two multicentre, randomized and vehicle-controlled studies Br J Dermatol 2012 Mar;166(3):633-41) and Journal of drugs in dermatology (Gao L, Gao N, Song W, Dang E, Yin R, Wang L, Wang G. A Retrospective Study on Efficacy of Pulsed Dye Laser and Intense Pulsed Light for the Treatment of Facial Telangiectasia J Drugs Dermatol 2017;16(11):11 12-1116) taken by us as prototypes.

The two multicenter, randomized, placebo-controlled studies described in the Brimonidine Phase II Study Group. Once-daily topical brimonidine tartrate gel 0.5% is a novel treatment for moderate to severe facial erythema of rosacea: results of two multicentre, randomized and vehicle-controlled studies conducted in 2011-2013. in the USA are:

1. Study A, which included 122 patients with erythematous-telangiectatic rosacea subtype treated with topical application of 0.07%, 0.18%, 0.5% brimonidine tartrate gel and placebo once, patients were allocated in a ratio of 1:1 :1:1. Efficacy was assessed at baseline, 30 minutes, and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after study drug administration.

2. Study B, which included 269 patients with erythematous-telangiectatic rosacea subtype who received topical application of brimonidine tartrate 0.5% gel once daily, brimonidine tartrate 0.18% gel once daily, placebo gel once per day, 0.18% brimonidine tartrate gel twice daily, and placebo gel twice daily for 4 weeks and 4 weeks of follow-up, patients were distributed in a ratio of 1:1:1:1:1.

Both studies evaluated erythema intensity, self-assessment, chromatometer measurements, and evaluation of adverse events.

As a result, in study A, a single application of topical brimonidine tartrate gel reduced facial erythema in a dose-dependent manner. There was a significant difference between application of brimonidine tartrate 0.5% gel and placebo gel when assessing erythema with a chromatometer. In Study B, application of brimonidine tartrate 0.5% gel once daily was statistically superior to placebo gel and compared to other treatments.

A retrospective Study on Efficacy of Pulsed Dye Laser and Intense Pulsed Light for the Treatment of Facial Telangiectasia included 416 patients with erythematous-telangiectatic subtype of rosacea (2012-2015, China) to compare the efficacy of pulsed dye laser ( PDL) and Intense Pulsed Light (IPL) systems for the treatment of facial telangiectasia.

Patients received one of the following five treatments: PDL 595 nm (9-12 J/cm2), MaxG (500-670 nm and 870-1200 nm, 30-46 J/cm2), IPL (560-1200 nm, 18 - 24 J/cm2), M22 560 (560-1200 nm, 15-18 J/cm2) and M22 590 (590-1200 nm, 15-20 J/cm2). Each treatment consisted of two sessions at 6-week intervals. Percentage improvement in skin condition in the form of facial telangectasia coagulation after final treatment was evaluated by two different physicians. Almost all patients were found to have marked improvements.

However, to achieve a pronounced clinical effect and stable remission in the treatment of erythematous-telangiectatic subtype of rosacea, reducing the duration of treatment, monotherapy, as a rule, is not enough. Therefore, usually 2-3 drugs or methods are used that enhance and / or complement each other's action.

Unfortunately, rosacea is still a chronic disease, and all we can achieve in the treatment of a patient with rosacea is to achieve stable remission and control of exacerbations.

In view of the above, there is a need to develop a more effective method for the treatment of rosacea, which does not have the side effects observed in known treatments.

The invention is directed to the development of an effective combined method for the treatment of erythematous-telangiectatic rosacea subtype, predominantly of mild and moderate forms, which will provide a pronounced therapeutic effect, reduce the duration of therapy compared to other treatment methods and lengthen the period of remission.

We have developed a pathogenetic complex method of treatment, including a combination of broadband pulsed light radiation with topical application of 0.5% brimonidine tartrate gel in patients with erythematous-telangectatic rosacea subtype. The method will allow to reduce the course of phototherapy procedures and obtain a pronounced clinical effect.

A method for combined therapy of rosacea of the erythematous-telangectatic subtype is proposed, which consists in external application of 0.5% brimonidine tartrate gel to the affected skin daily, 1 time per day, in the morning, for 3 months, and the drug is applied in a thin layer to the affected areas: forehead and / or cheeks and/or nose and/or chin, avoiding contact with lips, eyes, mucous membranes; parallel carrying out procedures of broadband pulsed light radiation with a wavelength range of 500-1200 nm on the M22 multi-module platform using the IPL (Intensive pulse light) nozzle, and the procedures are carried out 1 time in 28-30 days, the course is 3 procedures, and after the completion of the procedure on the device M22 patients are treated with photoprotectors with a protection factor of 50 on the affected areas.

The technical result is an increase in the period of remission up to several years, a significant reduction in the number of procedures for exposure to radiation (up to 3 procedures, i.e. two to three times less compared to the usual course of treatment), more comfortable treatment.

Since the course of treatment becomes shorter due to combination therapy, the likelihood of side effects from exposure to drugs and from procedures is reduced.

The M22 device (IPL) allows you to dose the pulse energy, control the duration of the flash, use various filters for a more targeted effect on the skin vessels. Due to this, the frequency of procedures is reduced, the time of the procedure is reduced, the total number of procedures is reduced to 3. The patient tolerates the procedure more comfortably, the possible side effects associated with exposure to radiation are reduced, and the gel based on brimonidine tartrate enhances the effect and increases the remission period up to several years .

To achieve a technical result, it is necessary to carry out procedures for exposure to broadband pulsed radiation, an exposure mode is required once every 28-30 days with a course of 3 procedures, after the procedure is completed on the M22 apparatus, photoprotectors with a protection factor of 50 are applied to the affected areas.

Combined therapy allows you to change the approach to the treatment of rosacea and qualitatively improve the results of treatment.

Disclosure of the essence of the invention

The technical result consists in increasing the effectiveness of therapy for the erythematous-telangectatic subtype of rosacea by applying a treatment method that includes a combination of broadband pulsed light radiation with topical application of 0.5% brimonidine tartrate gel.

Brimonidine tartrate belongs to the group of highly selective α ₂ -adrenergic agonists, causing a decrease in rosacea erythema due to direct vasoconstriction of small blood vessels in the dermis. The effectiveness of the drug 0.5% gel brimonidine tartrate (Mirvaso Derm®) in rosacea is also associated with an anti-inflammatory effect.

Broadband pulsed light (M22, IPL nozzle (Intensive pulse light) is used to maintain a long-term effect and coagulate superficial vessels in the form of telangiectasias. The principle of the biological effect of IPL on skin structures is the absorption of photons by endogenous or exogenous chromophores located in different layers of the skin, which leads to a local rise in temperature and destruction of structures containing chromophores.The hemoglobin of erythrocytes present in the vessels of the skin has the properties of a chromophore.

The main result of the proposed method of treatment is to obtain a pronounced therapeutic effect, namely a significant reduction in the number of telangiectasias, a decrease in the severity of erythema, as well as a reduction in the duration of therapy compared to other methods of treatment and an extension of the remission period, by using a clinically proven scheme for the complex treatment of rosacea.

The new technical result is achieved due to the fact that the combined therapy method includes external application of 0.5% brimonidine tartrate gel (Mirvaso Derm) to the affected skin, which is applied daily, once a day, in the morning, for 3 months. The drug is applied in a thin layer on the "affected areas" (forehead, cheeks, nose and / or chin), avoiding contact with lips, eyes, mucous membranes. In parallel, procedures of broadband pulsed light radiation are carried out on the M22 multi-module platform using the IPL (Intensive pulse light) nozzle. Procedures are carried out 1 time in 28-30 days, the course is 3 procedures. After completing the procedures on the M22 device, patients are recommended to use photoprotectors with a protection factor of 50 on the affected area in order to prevent the development of pigmentation.

Implementation of the invention

The method is carried out as follows.

The patient undergoes a dermatological examination, including an assessment of the severity of clinical signs of rosacea according to the scale of diagnostic assessment of rosacea (Adaskevich V.P., 2004), before and after treatment.

In order to study the morphological changes and the functional state of the microvasculature in the skin, a multispectral analysis of the skin was used using the Antera 3D scanning device (Miravex, Ireland, registration number of the declaration of conformity - EAEU No. RU D-IE.AL16.V.76453) real-time assessment of the morphological structure of the pathological skin, as well as create a map of the distribution of hemoglobin and measure its concentration in the lesions. The Antera 3D device allows you to measure three different parameters that reflect the hemoglobin content:

1. Total hemoglobin level: the parameter shows the average concentration of hemoglobin in a certain selected area.

2. Hemoglobin Deviation: This parameter provides information on the degree of hemoglobin homogeneity in a certain selected area. Although the average hemoglobin value may depend on the patient's skin type, the distribution of hemoglobin is specific to each individual. The closer the value is to zero, the more uniform the distribution of hemoglobin and the better the skin color.

3. Relative hemoglobin distribution in percent: the parameter shows the ratio of the total hemoglobin level and the hemoglobin deviation value, indicates the uniformity of the hemoglobin distribution. Its percentage value gives information about the uniformity of the hemoglobin level in the studied tissues.

The course of treatment began with the application of 0.5% brimonidine tartrate gel to the affected skin, which was applied daily, 1 time per day, in the morning, for 3 months. The drug is applied in a thin layer on the "affected areas" (forehead, cheeks, nose and / or chin), avoiding contact with lips, eyes, mucous membranes. In parallel, we performed broadband pulsed light radiation procedures on the M22 multimodule platform using the IPL (Intensive pulse light) attachment. The procedures were carried out 1 time in 28-30 days, the course included 3 procedures.

In order to correct erythema, 0.5% brimonidine tartrate gel was applied, which was applied to the skin of the face in the morning once a day. Reduction of erythema occurs due to direct vasoconstriction of small blood vessels in the dermis, as well as anti-inflammatory action. Brimonidine tartrate 0.5% gel is represented by Mirvaso Derm gel for external use (Galderma, France, reg. No: LP-003563 dated 04/12/16). In order to maintain a long-term effect and correct stable dilatation of superficial vessels in the form of telangiectasias, we used the method of broadband pulsed light radiation on the M22 multi-module platform (Lumenis, USA, approved by the Ministry of Health of the Russian Federation (registration number of Roszdravnadzor - FSS 2012/12713) using the IPL nozzle (Intensive pulse light).The principle of the biological effect of IPL on skin structures is the absorption of photons by endogenous or exogenous chromophores located in different layers of the skin, which leads to a local rise in temperature and destruction of structures containing chromophores. The hemoglobin of erythrocytes present in the vessels of the skin has the properties of a chromophore. We have used the unique OPT optimal impulse technology, which allows more constant energy to be transferred to the removed vessel without fluctuations and negative consequences (burns), and the contact cooling technology provides additional heat removal from the epidermis during impact that contributes to the effectiveness of treatment. The therapeutic parameters of pulsed light radiation (pulse duration and flash energy), filters were determined taking into account the skin phototype, the presence of erythema, the number of telangiectasias, their depth in the lesion, and protocols for broadband pulsed light radiation were developed.

We used the following parameters: wavelength 500-1200 nm, fluence 10-35 J/cm², three types of pulses, pulse duration 4-20 ms, delay between pulses 5-150 ms, frequency up to 1 Hz, spot size 15 x 35mm² and /or 8 x 15mm².

The ability to obtain a pronounced therapeutic effect, namely to reduce the severity of erythema, significantly reduce the number of telangectasias, as well as reduce the duration of therapy compared with other methods of treatment and lengthen the period of remission, is based on an analysis of the results of clinical trials.

The study looked at rosacea as a chronic facial skin disease leading to a deterioration in the quality of life of patients.

The aim of the study was to develop a complex pathogenetic method for the treatment of erythematous-telangectatic subtype of rosacea, using 0.5% brimonidine tartrate gel and broadband pulsed light radiation with a wavelength range of 500-1200 nm, based on hemoglobin concentration in lesions.

Study: open prospective. Under observation were 60 female patients aged 26 to 55 years with a diagnosis of erythematous-telangectatic subtype of rosacea. In addition, we took into account the phototype of the patients, which was determined in accordance with the classification of skin phototypes according to Vladimirov V.V.: the first phototype - 36 patients, the second - 18, the third - 6. The control group consisted of 20 healthy female volunteers aged 25 to 63 years.

In patients, the clinical picture was similar: the pathological process was localized on the skin of the forehead, nose, cheeks, chin, temples, the following primary and secondary diagnostic criteria were determined: transient or persistent diffuse erythema with indistinct boundaries, multiple telangectasias, moderate swelling and dry skin in the lesions defeat; subjectively, there was a burning sensation, tingling, tightening of the skin of the face, itching, a feeling of warmth and "tides" of the skin. In the clinical and morphological analysis of the study group of patients on a scale for assessing the severity of clinical signs in each patient, we determined the severity of the erythematous-telangectatic subtype of rosacea. We found that 18 (30%) patients had incoming transient erythema, and in the majority of 42 (70%) patients, persistent persistent erythema prevailed.

Depending on the treatment regimen, all patients were divided into 3 groups.

In the 1st group (20 people), patients used: brimonidine tartrate gel 0.5% - on the skin of the face with a thin layer on the "affected areas" (forehead, cheeks, nose and / or chin), avoiding contact with the mucous membranes of the eyes and lips , 1 time per day in the morning.

In the 2nd group (20 people), patients underwent only procedures of broadband pulsed light radiation on the multi-module platform "M22" using the IPL nozzle (course 3 procedures, with an interval of 1 month).

In the 3rd group (20 people), patients underwent complex treatment using brimonidine tartrate gel 0.5%, daily, 1 time per day, in the morning. After 7-10 days, the patients underwent procedures of broadband pulsed light radiation on the multi-module platform "M22" using the IPL nozzle (course 3 procedures, with an interval of 1 month).

Determination of the parameters of broadband pulsed light radiation with a wavelength range of 500-1200 for patients with erythematous-telangectatic subtype was carried out depending on the skin phototype, the prevalence of erythema and the depth of telangectasia.

With the predominance of erythema and with the presence of single telangectasias, the following parameters for choosing light radiation are recommended:

- for 1 skin phototype - Skin Treatment mode, filters: 515, 560, crystal: rectangular, energy (fluence) 17-20 J/cm2, pulse duration: ⁶ ms;

- for 2 skin phototypes - Skin Treatment mode, filters: 515, 560, crystal: rectangular, energy (fluence) 16-19 J/cm2, pulse duration: ⁶ ms;

- for 3 skin phototypes - Skin Treatment mode, filters: 515, 560, crystal: rectangular, energy (fluence) 15-18 J/cm2, pulse duration: ⁶ ms.

2. With the predominance of superficially located telangectasias with a diameter of > 0.6 mm (depth of occurrence up to 1.5 mm), the following parameters for choosing light radiation are recommended:

- for 1 skin phototype - Skin Treatment mode, filters: 515, 560, crystal: rectangular, energy (fluence) 20-23 J/cm2, pulse duration: ⁶ ms;

- for 2 skin phototypes - Skin Treatment mode, filters: 515, 560, crystal: rectangular, energy (fluence) 19-22 J/cm2, pulse duration: ⁶ ms;

- for 3 skin phototypes - Skin Treatment mode, filters: 515, 560, crystal: rectangular, energy (fluence) 18-21 J / cm ² , pulse duration: 6 ms.

3. With the predominance of deeply located telangectasias with a diameter of up to 0.6 mm (depth of occurrence from 1.5 mm to 2.5 mm), the following parameters for choosing light radiation are recommended:

- for 1 skin phototype - Skin Treatment mode, filters: 515, 560, 590, crystal: rectangular, energy (fluence) 22-25 J/ ^cm2 , pulse duration: 6.6 ms;

- for ² skin phototypes - Skin Treatment mode, filters: 515, 560, 590, crystal: rectangular, energy (fluence) 21-24 J/cm2, pulse duration: 6.5 ms;

- for 3 skin phototypes - Skin Treatment mode, filters: 515, 560, 590, crystal: rectangular, energy (fluence) 20-23 J/cm2, pulse duration: ⁶ ms.

Table 1 presents the results of a clinical evaluation of the effectiveness of the treatment in groups of patients. As can be seen, 1 month after the start of treatment, a slight improvement was observed in 4 patients (20.0%) of group 1, somewhat less often - in 9 patients (45.0%) of group 2, and 2 times less often - in 6 patients (30. 0%) of group 3. At the same time, the revealed differences in indicators in groups 1 and 3 did not reach statistically significant differences (p=0.057).

In the same period of the study, improvement due to the therapy was observed in 4 cases (20.0%) in the first group, in 6 patients (30.0%) of the second group, and in the third group 2 times more often than in group 1 - in 8 patients (40.0%). However, no statistically significant intergroup differences were found.

The frequency of cases that qualified as a “significant improvement” was 20.0% (in 4 patients) in group 1, the value of this indicator was slightly higher in groups 2 and 3, amounting to 25.0% (5 cases) and 30, respectively, 0% (6 cases).

An analysis conducted 2 months after the start of treatment showed that a slight improvement during this period of the study was observed in 6 patients (30.0%) of group 1, in 4 patients (20.0%) of the second group, while in the third group only in 2 cases (10.0%). Improvement was noted in 6 cases (30.0%) in groups 1 and 2 and in 5 patients (25.0%) in group 3. A significant improvement was found in 8 patients (40.0%) in group 1, in 10 cases ( 50.0%) in group 2 and much more often - in 13 cases (65.0%) in the third group.

Treatment Effects Group 1
(n=20) Group 2
(n=20) Group 3
(n=20) Abs. % Abs. % Abs. % 1 month after starting treatment Minor improvement 12 60.0 nine 45.0 6 30.0 Improvement 4 20.0 6 30.0 8 40.0 Significant improvement 4 20.0 five 25.0 6 30.0 clinical recovery - - - - - - 2 months after starting treatment Minor improvement 6 30.0 4 20.0 2 10.0 Improvement 6 30.0 6 30.0 five 25.0 Significant improvement 8 40.0 10 50.0 13 65.0 clinical recovery - - - - - - 3 months after starting treatment Minor improvement - - - - - - Improvement - - - - - - Significant improvement 3 15.0 one 5.0 - - clinical recovery 17 85.0 19 95.0 twenty 100.0

Table 1

After 3 months, the absolute majority of patients in all three groups showed clinical recovery - in 17 (85.0%), 19 (95.0%) and 20 (100.0%) patients of the first, second and third groups, respectively. Only 3 patients (15.0%) in the group where monotherapy with 0.5% brimonidine tartrate gel was performed showed a significant improvement, in group 2, where broadband pulsed light procedures were used on the M22 multimodule platform, there was only one such a case (5.0%). At the same time, in the third group, where a combination of 0.5% brimonidine tartrate gel and broadband pulsed light procedures on the M22 multimodule platform was used, there were no such patients, since all study participants were diagnosed with clinical recovery.

When assessing the dynamics of the disease on the SDOR scale after complex therapy, in 48 (80%) patients with mild severity, the mean score regressed from 3.5±1.4 to 1.5±0.5 points, in 12 (20%) ) patients with moderate severity from 9.6±1.2 to 2.5±1.5 points .

When assessing the dynamics of the skin condition of the face of patients with erythematous-telangectatic subtype of rosacea using the Antera 3D device in patients of the study group and healthy donors, we obtained the following results:

- The indicator of the total hemoglobin level in all patients (n=60) before treatment was 3.5 ± 2.3, after complex therapy 1.1 ± 0.5, which corresponds to the average indicator of the total hemoglobin level in the control group 1.3 ± 0 ,3 (n=20)

- The indicator of hemoglobin deviation in all patients (n=60) before treatment was 0.6 ± 0.2, after treatment 0.2 ± 0.08, which corresponds to the average hemoglobin deviation in the control group of 0.25 ± 0.03

- The relative distribution of hemoglobin in percent in all 60 patients after treatment averaged 55 ± 5%

Among all patients treated with broadband pulsed light radiation, there was a good tolerability of the procedures. In most cases, after the procedure, in the lesions on the skin of patients with rosacea, the disappearance or darkening of the vessels was noted, which indicated an adequate selection of the parameters of light radiation. The undesirable effects of the use of broadband pulsed light radiation included minor erythema and swelling of the treated area of the skin, single hemorrhages. However, these phenomena were temporary and resolved 2-3 days after the procedure.

Thus, for patients with erythematous-telangectatic subtype of rosacea, the minimum number of procedures with broadband pulsed light radiation necessary to achieve a clinical effect was 3 procedures, taking into account the external therapy included in the treatment complex with 0.5% brimonidine tartrate gel.

So, at the end of the course of complex treatment, clinical recovery in the form of achieving the effect of "clear skin" (absence of erythema and telangectasias) was observed in 56 (93.3%) patients.

Examples of the implementation of the invention

Example 1

Patient M., 35 y.o., came to the clinic "CIDC" with complaints of redness on the skin of the nose, cheeks, chin, forehead, blood vessels of the skin of the nose, chin, cheeks, burning sensation and tingling, itching, tightening of the skin, feeling of warmth, " tides."

Considers himself a patient for more than 5 years. The patient notes on the skin of the face a periodically appearing increase in redness after drinking hot drinks, spicy food. I didn’t go to a dermatologist, I used Rosex on my own, it became “a little better”, the effect lasted up to 1 month.

She went to the clinic to clarify the treatment.

Of past diseases: chronic gastritis in remission.

Allergy anamnesis is not burdened.

The skin is of normal color, moisture and elasticity of the skin is normal. Visible mucous membranes are pink, clean, there is no icteric staining of the frenulum of the tongue and sclera. The conjunctiva of the eyes is pink. Skin turgor is preserved. The hairline is developed according to age.

Status localis: skin type: combined. Phototype according to Vladimirov 1. Skin moisture is reduced. Skin turgor is normal. The pathological process is represented by bright pink erythema in the central part of the face, with multiple telangiectasias. There are multiple open comedones on the cheeks and nose.

Hair, nails without features

Erythema: transient.

According to the SDOR scale: mild severity.

Data when examining the skin on the Antera 3D device:

Total hemoglobin level before treatment 1.7

Deviation of hemoglobin before treatment 0.82

Relative distribution of hemoglobin in percent before treatment 100%

Clinical diagnosis: Rosacea ICD10: L71.

Mode: outpatient.

The patient underwent the first skin phototreatment procedure on the "M22" device (Skin Treatment mode, filter: 590, crystal: rectangular, energy (fluence) 22-25 J/cm ² , pulse duration: 6.6 ms.).

Appointments:

1. The course of phototherapy procedures on the apparatus M22, N3 with an interval of 1 month:

- After phototherapy, do not apply decorative cosmetics for 1 day after;

- Limit the intake of chocolate, sweets, etc .;

- Use of a sunscreen after the procedure for 1 month spf50+. Use of a regenerating, moisturizing cream for 1 week (Bepanten);

2. External application of 0.5% brimonidine tartrate gel "Mirvaso Derm" (daily, 1 time per day, for 3 months). Apply the drug in a thin layer on the "affected areas" (cheeks, nose, forehead, chin), avoiding contact with lips, eyes, mucous membranes.

The patient came for a follow-up appointment 1 month after treatment, with improvement. The therapy is well tolerated, there are no side effects, there is redness on the skin of the nose, cheeks, chin, forehead.

Status localis: erythema and single telangiectasias are noted on the skin of the face.

The patient underwent the second skin phototreatment procedure on the "M22" apparatus (Skin Treatment mode, filter: 590, crystal: rectangular, energy (fluence) 22-25 J/cm ² , pulse duration: 6.6 ms).

Appointments:

1) Continue the course of procedures No. 3 (repeated procedure after 3 weeks).

2) Continue external application of Mirvaso Derm brimonidine tartrate gel 0.5% (daily, once a day, for 3 months). Apply the drug in a thin layer on the "affected areas" (cheeks, nose, forehead, chin), avoiding contact with lips, eyes, mucous membranes.

The patient returned for a follow-up appointment 1 month after the second phototherapy, with improvement. The therapy is well tolerated, no side effects are noted, redness on the skin of the nose, cheeks, and chin is noted.

Status localis: There are single telangiectasias on the skin of the face.

The patient underwent the third procedure of phototherapy of the skin on the device "M22" (Skin Treatment mode, filter: 590, crystal: rectangular, energy (fluence) 22-25 J/cm ² , pulse duration: 6.6 ms).

Appointments:

1) Continue external application of Mirvaso Derm brimonidine tartrate gel 0.5% (daily, once a day, for 3 months). Apply the drug in a thin layer on the "affected areas" (cheeks, nose, forehead, chin), avoiding contact with lips, eyes, mucous membranes.

2) Appearance for a control examination.

After 4 months of treatment, redness of the face and telangectasia regressed, there were no new rashes, without subjective sensations.

Data when examining the skin on the Antera 3D device:

Total hemoglobin level before treatment 1.23

Deviation of hemoglobin before treatment 0.267

Relative distribution of hemoglobin in percent before treatment 55%

Thus, the above treatment regimen proved to be effective and safe for the treatment of erythematous-telangectatic subtype of rosacea (mild severity), while clinical recovery was achieved without the use of systemic drugs, as well as a reduction in the number of phototherapy procedures (usually 6-7 procedures are required).

Figure 1 photographs of the patient before and after treatment.

Example2

Patient C., aged 55, came to the clinic "CIDC" with complaints of skin rashes, redness, burning and tingling sensation, itching, skin tightening, feeling of warmth and hot flashes.

He considers himself a patient for 10 years, does not associate the onset of the disease with anything. Against the background of the use of alcoholic beverages and as a result of stress, there is an increase in "redness". I applied to a dermatologist for m / f before, the last time I used Metrogil, Demoten externally; inside Polysorb, noted a slight positive effect up to 4-5 months.

She went to the clinic to clarify the treatment.

Past diseases: Chronic gastritis, GB, hypothyroidism.

At the time of treatment, she was taking eutirox 100, rimonorm, and egilok.

Allergy anamnesis is not burdened.

The skin is of normal color, moisture and elasticity of the skin is normal. Visible mucous membranes are pink, clean, there is no icteric staining of the frenulum of the tongue and sclera. The conjunctiva of the eyes is pink. Skin turgor is preserved. The hairline is developed according to age.

Status localis: Skin type: combined.

Skin phototype according to Vladimirov: the third phototype. Skin moisture: dehydrated. Skin turgor: normal. Against the background of erythema in the area of the cheeks, nose and chin, papular rashes, multiple telangectasias are visualized.

Erythema is persistent.

According to the SDOR scale: moderate severity.

Data when examining the skin on the Antera 3D device:

Total hemoglobin level before treatment 4.5

Deviation of hemoglobin before treatment 0.66

Relative distribution of hemoglobin in percent before treatment 100%

Clinical diagnosis: Rosacea ICD10: L71.

Mode: outpatient.

The patient underwent the first skin phototreatment procedure on the "M22" device (Skin Treatment mode, filter: 560, crystal: rectangular, energy (fluence) 18-21 J/cm ^2, pulse duration: 6 ms).

Appointments:

1. The course of phototherapy procedures on the apparatus M22, N3 with an interval of 1 month:

- After phototherapy, do not apply decorative cosmetics for 1 day after;

- Limit the intake of chocolate, sweets, etc .;

- Use of a sunscreen after the procedure for 1 month spf50+. Use of a regenerating, moisturizing cream for 1 week (Bepanten);

2. External application of 0.5% brimonidine tartrate gel "Mirvaso Derm" (daily, 1 time per day, for 3 months). Apply the drug in a thin layer on the "affected areas" (cheeks, nose, forehead, chin), avoiding contact with lips, eyes, mucous membranes.

The patient came for a follow-up appointment 1 month after treatment, with improvement. The therapy is well tolerated, there are no side effects, there is reddening of the skin of the face.

Status localis: On the skin of the face in the cheek area, there is a slight erythema of a pale pink color and single telangiectasias.

The patient underwent the second skin phototreatment procedure on the "M22" device (Skin Treatment mode, filter: 560, crystal: rectangular, energy (fluence) 18-21 J/cm ^2, pulse duration: 6 ms).

Appointments:

1. Continue the course of procedures No. 3 (repeated procedure after 3 weeks).

2. Continue external application of Mirvaso Derm brimonidine tartrate gel 0.5% (daily, once a day, for 3 months). Apply the drug in a thin layer on the "affected areas" (cheeks, nose, forehead, chin), avoiding contact with lips, eyes, mucous membranes.

The patient returned for a follow-up appointment 1 month after the second phototherapy, with improvement. The therapy is well tolerated, no side effects are noted, redness on the skin of the chin is noted.

Status localis: A slight erythema is noted on the skin of the face in the cheek area.

The patient underwent the third procedure of skin phototreatment using the "M22" apparatus (Skin Treatment mode, filter: 560, crystal: rectangular, energy (fluence) 18-21 J/cm2 ^, pulse duration: 6 ms).

Appointments:

1. Continue external application of Mirvaso Derm brimonidine tartrate gel 0.5% (daily, once a day, for 3 months). Apply the drug in a thin layer on the "affected areas" (cheeks, nose, forehead, chin), avoiding contact with lips, eyes, mucous membranes.

2. Appearance for a control examination.

After 4 months of treatment, redness of the face and telangectasia regressed, there were no new rashes, without subjective sensations.

Data when examining the skin on the Antera 3D device:

Total hemoglobin level before treatment 0.81

Deviation of hemoglobin before treatment 0.234

Relative distribution of hemoglobin in percent before treatment 60%

Thus, the above treatment regimen proved to be effective and safe for the treatment of erythematous-telangectatic subtype of rosacea (moderate severity), while clinical recovery was achieved without the use of systemic drugs, as well as a reduction in the number of phototherapy procedures (usually 6-7 procedures are required).

Figure 2 photographs of the patient before and after treatment.

Example 3

Patient P., aged 27, came to the clinic "CIDC" with complaints of redness of the face, burning sensation, "tightening" of the skin, a feeling of "hot flashes" and warmth, itching.

He considers himself ill for 1 year, does not associate the onset of the disease with anything. I went to a dermatologist, Rozamet was prescribed externally, without effect.

She went to the clinic to clarify the treatment.

Of past illnesses: Tension headache.

Allergy anamnesis is not burdened.

The skin is of normal color, moisture and elasticity of the skin is normal. Visible mucous membranes are pink, clean, there is no icteric staining of the frenulum of the tongue and sclera. The conjunctiva of the eyes is pink. Skin turgor is preserved. The hairline is developed according to age.

Status localis: Skin type: combined.

Skin phototype according to Vladimirov: the first phototype. Skin moisture: dehydrated. Skin turgor: normal. On the skin of the face there are bright red spider veins, diffuse hyperemia on the face in the forehead, cheeks, nose, chin.

Erythema is transient.

According to the SDOR scale: medium severity.

Data when examining the skin on the Antera 3D device:

Total hemoglobin level before treatment 5.36

Deviation of hemoglobin before treatment 1

Relative distribution of hemoglobin in percent before treatment 100%

Clinical diagnosis: Rosacea ICD10: L71.

Mode: outpatient.

The patient underwent the first skin phototreatment procedure on the "M22" apparatus (Skin Treatment mode, filter: 590, crystal: rectangular, energy (fluence) 22-25 J/cm ² , pulse duration: 6.6 ms).

Appointments:

1. The course of phototherapy procedures on the apparatus M22, N3 with an interval of 1 month:

- After phototherapy, do not apply decorative cosmetics for 1 day after;

- Limit the intake of chocolate, sweets, etc .;

- Use of a sunscreen after the procedure for 1 month spf50+. Use of a regenerating, moisturizing cream for 1 week (Bepanten);

2. External application of 0.5% brimonidine tartrate gel "Mirvaso Derm" (daily, 1 time per day, for 3 months). Apply the drug in a thin layer on the "affected areas" (cheeks, nose, forehead, chin), avoiding contact with lips, eyes, mucous membranes.

The patient came for a follow-up appointment 1 month after treatment, with improvement. The therapy is well tolerated, there are no side effects, there is reddening of the face, a burning sensation.

Status localis: on the skin of the face there is a slight erythema of a pale pink color and single telangiectasias.

The patient underwent the second skin phototreatment procedure on the "M22" apparatus (Skin Treatment mode, filter: 590, crystal: rectangular, energy (fluence) 22-25 J/cm ² , pulse duration: 6.6 ms).

Appointments:

1. Continue the course of procedures No. 3 (repeated procedure after 3 weeks).

2. Continue external application of Mirvaso Derm brimonidine tartrate gel 0.5% (daily, once a day, for 3 months). Apply the drug in a thin layer on the "affected areas" (cheeks, nose, forehead, chin), avoiding contact with lips, eyes, mucous membranes.

The patient returned for a follow-up appointment 1 month after the second phototherapy, with improvement. The therapy is well tolerated, there are no side effects, there is redness of the face.

Status localis: A slight erythema is noted on the skin of the face in the cheek area.

The patient underwent the third procedure of skin phototreatment using the "M22" device (Skin Treatment mode, filter: 590, crystal: rectangular, energy (fluence) 22-25 J/cm ² , pulse duration: 6.6 ms).

Appointments:

1. Continue external application of Mirvaso Derm brimonidine tartrate gel 0.5% (daily, once a day, for 3 months). Apply the drug in a thin layer on the "affected areas" (cheeks, nose, forehead, chin), avoiding contact with lips, eyes, mucous membranes.

2. Appearance for a control examination.

After 4 months of treatment, redness of the face and telangectasia regressed, there were no new rashes, without subjective sensations.

Data when examining the skin on the Antera 3D device:

Total hemoglobin level before treatment 1.59

Deviation of hemoglobin before treatment 0.239

Relative distribution of hemoglobin in percent before treatment 51%

Thus, the above treatment regimen proved to be effective and safe for the treatment of erythematous-telangectatic subtype of rosacea (moderate severity), while clinical recovery was achieved without the use of systemic drugs, as well as a reduction in the number of phototherapy procedures (usually 6-7 procedures are required).

Figure 3 photographs of the patient before and after treatment.

Thus, the above complex treatment scheme (topical use of 0.5% brimonidine tartrate gel and broadband pulsed light with a wavelength range of 500-1200 nm) is effective and safe for the treatment of erythematous-telangectatic subtype of rosacea (mild and moderate severity) , while clinical recovery was achieved in almost all patients.

Claims (1)

A method for combined therapy of rosacea of the erythematous-telangectatic subtype, which consists in externally applying 0.5% brimonidine tartrate gel to the affected skin daily, 1 time per day, in the morning, for 3 months, and the drug is applied to the affected areas: forehead, cheeks, nose and chin; they also carry out procedures of broadband pulsed light radiation with a wavelength range of 500-1200 nm on a multi-module M22 platform using an IPL (Intensive pulse light) nozzle, and the procedures are carried out 1 time in 28-30 days, a course of 3 procedures, and after the completion of the procedure, patients for affected areas are applied with photoprotectors with a protection factor of 50.

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