PULSED ELECTROMAGNETIC FIELD
Field The present disclosure relates to a mobile telecommunications device, a system for use in a method of treating the human body, a method of configuring or reconfiguring a mobile telecommunications device, a computer program and an app.
Introduction
Pulsed electromagnetic fields, "PEMF", therapy is established in the treatment of a wide spectrum of maladies, disease and conditions. Some devices that deliver PEMF operate in the radio frequency ranges and these have been proven to deliver benefit in a range of conditions.
Every living cell exports positive ions such as sodium and potassium to create an excess of positive charge on the outside of a cell. Therefore a potential difference across the cell membrane (transmembrane PD) exists. Typically this is about 40mV to say 90 mV, depending on cell type. Like all charged surfaces cell membranes will respond to a modulating EM field by small movements. This enlivens surface receptors and signalling systems that stimulate a cell to function more actively. The signalling systems in the membrane are provoked into stimulating cell activity by the movement. In the case of fibroblasts, for example, the function of this activity is the production of collagen. It is important however that the membrane is allowed to return to its resting position and therefore the EM fields are pulsed.
Pulsed Radio Wave Therapy devices are currently stand-alone dedicated devices which have a range of settings to provide the optimum pulse radio frequency signal and come at range of alarming costs, from $350 to $6,000. These devices commonly use electrode-like coils in contact with the body to deliver the PEMF.
Such devices commonly utilise dedicated remote controls or include the software and controls, screens etc. on board the device, increasing cost and reducing flexibility and the potential to upgrade programmes. Such devices are sold at a high price as after a
sale, manufacturers are limited to an income stream supplying low-cost, genericisable electrodes, gels, test strips etc. This raises the barrier to purchase and provides a lumpy income stream for manufacturers. Summary
Aspects of an invention are defined in the appended independent claims.
The inventors have identified that a smartphone or tablet, for example, with mobile telecommunications capability may be utilised, or reconfigured, to deliver pulsed electromagnetic fields (PEMF - both contact and non-contact) at therapeutic levels.
The use a smartphone, for example, for therapy is counterintuitive because the use of mobile phones is generally considered to be harmful, eg linked to local oedema, haematoma and even brain cancer. This is due to the continuous wave nature of a radio signal for telecommunications. In contrast, the present disclosure relates to the use of pulsed radio waves for therapy.
In embodiments, further accessories enhance or supply the PEMF generated by the mobile device. For example, in other embodiments, the combined use of such devices with therapeutic gels provides a synergistic effect. Embodiments take advantage of the connected nature of the mobile device to download different therapeutic programmes and to take micro payments for the use of the programmes.
Embodiments use the connected nature of the device to enable patient details, records of usage, results, progress etc. to be stored both on the device and in the cloud for consultation with a therapist/physician.
The present disclosure provides:
- non-contact Pulsed Radio Frequency device;
- pulsed Electromagnetic Field Therapy;
control of electronic therapeutic and diagnostic devices; and
eGels.
The inventors have recognised that a mobile device - such as a portable mobile communications device or cellular device or tablet - may be configured or reconfigured to provide functionality which is otherwise only provided by dedicated devices. In particular, the inventors have recognised that telecommunications antenna of mobile telecommunications devices may be driven for use in a method of treatment of the human body - rather than just for telecommunication.
Brief description of drawings Embodiments of the present disclosure will now be described with reference to the accompanying drawings in which:
Figure 1 shows a mobile device emitting a PEMF;
Figures 2a and 2b show PEMF electrodes connected via the earphone jack of a mobile device;
Figures 3a and 3b shows PEMF electrodes connected via an input/output port of a mobile device;
Figure 4 shows PEMF electrodes connected & controlled wirelessly
(Bluetooth/WiFi/NFC) via intermediary controller/power source;
Figure 5 shows PEMFC electrodes (which may or may not be connected themselves) connected and controlled directly via wireless technology;
Figure 6 shows PEMF electrodes connected and controlled via wireless technology and built into device intended to e.g. be laid on, wrapped around head, placed under pillow etc;
Figure 7 shows PEMF electrodes connected and controlled via wireless technology and built into wearable device; and
Figure 8 shows a chart displaying relative profilometry data wherein a mobile telecommunications app was used to deliver a PEMF to participants.
In the figures, like reference numerals refer to like parts.
Detailed description of embodiments
In overview, the present disclosure relations to converting personal radio devices such as smart phones into pulsed radio wave therapy devices.
Embodiments relate to device configured for use in a method of treating the human body but it may be appreciated that the present disclosure is equally applicable to the treatment of an animal body. Embodiments disclosed comprise two PEMF electrodes by way of non-limiting example only. The present disclosure extends to any number of PEMF electrodes. An embodiment is shown in Figure 1.
Figure 1 shows a mobile telecommunications device 101 arranged to emit a PEMF. The mobile telecommunications devices comprises a driver arranged to produce an electrical signal configured to drive an antenna to emit a pulsed electromagnetic field configured for use in a method of treating the human body.
In embodiments, the mobile telecommunications device is arranged for wireless telecommunication with other mobile telecommunications devices. In embodiments, the mobile telecommunications device is a mobile telephony device. However, it will be appreciated that the present disclosure extends to the modification of any mobile telecommunications device.
In embodiments, the pulsed electromagnetic field is configured to interact with the human body. In embodiments, the pulsed electromagnetic field has at least one parameter selected to enhance the interaction (of the PEMF) with the human body.
In embodiments, the pulsed electromagnetic field has a frequency in the GSM frequency band. In embodiments, the pulsed electromagnetic field has a frequency of 300 to 3000 MHz, optionally, 2300-2500 MHz, further optionally, 2400-2483.5 MHz. In embodiments, the pulsed electromagnetic field is emitted in 5-15 minute bursts separated by rest periods of 1-10 minutes, optionally 9-11 minute bursts separated by rest periods of 4-6 minutes. In other embodiments, the pulsed electromagnetic field is
emitted in 1 to 120 second bursts separated by rest periods of 1 to 120 seconds. In embodiments, the PEMF is emitted in pulses at 5-100 Hz, optionally 10 to 40 Hz, further optionally, 10 to 20 Hz. In embodiments, the pulse bursts are emitted for periods of 0.5-4 hours, optionally, 1.5-2.5 hours. In other embodiments, the pulses are emitted for 1 to 12 hours, optionally, 3 to 9 hours.
In embodiments the mobile telecommunications device is arranged to vary the pulse frequency of the pulsed electromagnetic field during treatment. It may be understood that the pulse electromagnetic field is emitted at a first pulse frequency for a first time period, followed by a second pulse frequency for a second time period, wherein the first pulse frequency is different from the second pulse frequency. In embodiments the first pulse frequency is lower than the second pulse frequency. In other embodiments, the first pulse frequency is higher than the second pulse frequency. In the embodiment shown in Figure 1, the antenna is an internal antenna of the mobile telecommunications device. In embodiments, the antenna is a radio-frequency mobile telecommunications antenna of the mobile telecommunications device. In
embodiments the antenna is a Bluetooth™ antenna. In embodiments the antenna is a WiFi antenna. In embodiments the antenna is an NFC antenna.
A further embodiment is shown in Figures 2a and 2b.
Figure 2a shows a mobile telecommunications device 201 connected to two PEMF electrodes 205 via the earphone jack of the mobile communications device 201. The PEMF electrodes 205 are driven to emit the PEMF 203.
Figure 2b shows a mobile telecommunications device 207 connected to two PEMF electrodes 211 via the earphone jack of the mobile communications device 207 and via an intermediary device 213. The PEMF electrodes 211 are driven to emit the PEMF 209.
In embodiments, it may therefore be understood that the antenna is an external antenna coupled to the mobile telecommunications device. In embodiments, the external antenna is wired to the mobile telecommunications device. In the
embodiments, the external antenna is wired to a headphone or microphone jack of the mobile telecommunications device.
Embodiments are shown in Figures 3 a and 3b.
Figure 3a shows a mobile telecommunications device 301 connected to two PEMF electrodes 305 via an input/output, "I/O", port of the mobile communications device 301. The PEMF electrodes 305 are driven to emit the PEMF 303. Figure 3b shows a mobile telecommunications device 307 connected to two PEMF electrodes 311 via an input/output, "I/O", port of the mobile communications device 307 and via an intermediary device 313. The PEMF electrodes 311 are driven to emit the PEMF 309. It may therefore be understood that, in embodiments, the external antenna is wired to an input-output port of the mobile telecommunications device.
An embodiment is shown in Figure 4. Figure 4 shows a mobile telecommunications device 401 wirelessly-connected to two PEMF electrodes 405 via an intermediary controller or power source 407. The PEMF electrodes 405 are driven to emit the PEMF 403. In embodiments, the wireless- connection utilises the Bluetooth 409, WiFi 411 or NFC 413 protocol. It may therefore be understood that in embodiments, the external antenna is wirelessly-coupled to the mobile telecommunications device. In embodiments, the external antenna is wirelessly-coupled to the mobile telecommunications device by Bluetooth, WiFi or NFC. In embodiments, the external antenna further comprises an intermediary controller or an intermediary power source.
A further embodiment is shown in Figure 5.
Figure 5 shows a mobile telecommunications device 501 wirelessly-connected to two PEMF electrodes 505. The PEMF electrodes 505 are driven to emit the PEMF 505.
The wireless-connection utilises the Bluetooth 507, WiFi 509 or NFC 511 protocol. In this embodiment, the PEMF electrodes 505 are connected and controlled directly via wireless technology. The PEMF electrodes 505 may or may not be connected themselves.
Another embodiment is shown in Figure 6.
Figure 6 shows a mobile telecommunications device 601 wirelessly-connected to a device 605 intended to be laid on, wrapped around the head and/or placed under a pillow, for example. The wireless-connection utilises the Bluetooth 607, WiFi 609 or NFC 611 protocol. PEMF electrodes are built into the device 605 and are driven to emit the PEMF 603. The electrodes are therefore connected and controlled via wireless technology. It may be understood that there is therefore provided a system for use in a method of treating the human body, the system comprising: the mobile telecommunications device as per the earlier embodiments; and a peripheral device arranged to house the external antenna. In embodiments, the peripheral device is a device arranged to receive the human body. In embodiments, the device is a device arranged to be laid on, a device arranged to wrap around the head or a device arranged to be placed under a pillow.
A yet further embodiment is shown in Figure 7.
Figure 7 shows a mobile telecommunications device 701 wirelessly-connected to a wearable device 705. The wireless-connection utilises the Bluetooth 707, WiFi 709 or NFC 711 protocol. PEMF electrodes are built into the wearable device 705 and are driven to emit the PEMF 703. The electrodes are therefore connected and controlled via wireless technology.
In embodiments, the peripheral device is a wearable device such as a watch.
In embodiments, the device is used with a gel. In embodiments, the system further comprises a gel configured for use in the method of treating the human body. In embodiments, the gel is configured to improve coupling of the pulsed electromagnetic field into the human body.
In embodiments, the PEMF treatments are used in conjunction with a generic electrode gel to provide good contact. In embodiments, these gels convey no therapeutic benefit. Embodiments use a gel, from a range of possible gels, which work synergistically with the PEMF devices (contact or non-contact). The effect of the gels may be enhanced by the use of PEMF or the gels may convey/amplify the current/field of the device or a combination of the two. In embodiments, there is provided a unique combination of a particular gel with a particular device, or an application setting on a particular device (e.g. "bone healing", "tendon repair" etc.). In embodiments, the combination of gel and device/application is approved together as a treatment (cf. a pharmaceutical plus a particular delivery device).
In embodiments, the pulsed electromagnetic field and gel are arranged to act upon at least one biological cell to provide a therapeutic effect, optionally a synergistic therapeutic effect. In embodiments, the at least one biological cell is a plurality of biological cells. In embodiments, the at least one biological cell is a human cell or an animal cell.
In embodiments, the pulsed electromagnetic field is arranged to stimulate the at least one biological cell to initiate production of a substance and the gel is configured to enhance production of the substance.
In embodiments, the gel is configured to stimulate the at least one biological cell to initiate production of a substance and the pulsed electromagnetic field is arranged to enhance production of the substance.
In embodiments, the substance is collagen.
In embodiments, the gel is configured to supply nutrients to the at least one biological cell and the pulsed electromagnetic field is arranged to enhance absorption of the nutrients into the at least one biological cell.
In embodiments, the substance is a peptide, optionally Palmitoyl tetrapeptide 7, and Palmitoyl tripeptide 1. In embodiments, the gel is configured to supply nutrients to the at least one biological cell and the pulsed electromagnetic field is arranged to enhance absorption of the nutrients into the at least one biological cell.
In embodiments, the pulsed electromagnetic field is arranged to stimulate at least one biological cell and the gel is arranged to supply nutrients to the stimulated at least one biological cell.
There is provided a method of configuring, or reconfiguring, a mobile
telecommunications device to drive an antenna with an electric signal to emit a pulsed electromagnetic field configured for use in a method of treating the human body.
The skilled person will understand that this configuring or reconfiguring of a mobile telecommunications device may be achieved using any one of a variety of different hardware and software solutions. In embodiments, an additional driver is coupled to the mobile telecommunications device to provide the appropriate signals to a telecommunications antenna. The skilled person understands how to design an additional driver to provide the appropriate electric signals for an antenna. In embodiments, the driver is controllable by an App installed on the mobile
telecommunications device. The skilled person knows how to provide an App for driving the additional driver.
The skilled person will understand that in embodiments it may be necessary to disable a telecommunication function of the device whilst the electric signal in accordance with embodiments of the present disclosure is provided to the antenna. The skilled
person understands how any necessary switching might be provided to accommodate the driver in accordance with embodiments of the present disclosure.
There is therefore provided a computer program or app arranged to provide instructions to a driver of a mobile telecommunications device to produce an electrical signal configured to drive an antenna to emit a pulsed electromagnetic field configured for use in a method of treating the human body.
In an embodiment, the computer program or app is further arranged to receive user- selection of a treatment programme from a plurality of treatment programmes wherein the treatment programme defines parameters of the electrical signal.
In an embodiment, the computer program or app is further arranged to receive payment from a user for the user-selected treatment programme and, optionally, a gel to accompany the treatment programme.
In an embodiment, the computer program or app is further arranged to store or upload data related to use of the treatment programmes. In an embodiment, the computer program or app is further arranged to store or upload medical data obtained from a user of a treatment programme.
There is provided an installed App or modification to a smart phone or mobile telephone that when operated takes control of the radio frequency transmitter portion of the device to provide pulsed radio waves at a signal strength appropriate to treat an individual within a few meters of the device.
In embodiments, various apps are installed for various therapies that modify the pulse radio-wave profile to suit. In embodiment, the application:
a. provides a selection of therapies to the user and thus tells the control application which programme to apply (for example, varying the voltage, current, length of treatment, pulsing of current (time of pulse and time between pulse), etc.); b. enables the user to purchase and download additional therapy programmes; c. enables micropayments to be taken, for example:
i. in- App pay-per use for the programmes
ii. download top up credits to enable the use of programmes (cf. pay-as- you-go phones)
In embodiments, the app is designed to arrange micropayments for pay-per-use or top up credits. In embodiments, the app is sold in combination with a gel to accompany and enhance the radio wave therapy effect for use with:
o Cosmetic gels
o Pain relieving gels
o Biolubrication gels
o Regenerative gels
o Wound healing gels
In embodiments, gels are sold with a credit allocation to be downloaded etc. In embodiments, gels are sold with usage credits, e.g. code in the box, QR code etc. that enables a certain amount of credits to be downloaded, linked to a particular treatment regime in the App., e.g. enough treatments for the expected life of the purchased gel (i.e. 11 treatments if the tube of gel contains 11 applications).
It may be recognised that any device with a radio signal can be modified to provide the device in accordance with the present disclosure. It may also be recognised that the present disclosure extends to exploiting any EM transmitter e.g. WiFi or Bluetooth functions.
There is provided an installed application on a mobile device (e.g. tablet or 'phone) that can control the voltage and current output from either the USB/MHL socket (5 V output max., Android and alike) or the headphone/microphone jack (2V output max.).
There is also provided an accessory electrode or electrodes, or intermediate control device that terminates in coils, that plug into the controlled socket to enable delivery pulsed electromagnetic fields to the body.
In embodiments using the 3.5mm headphone jack, this may pick up on the "live" microphone contact in the socket, thus the accessory may also retain a pass through headphone jack to enable to user to continue to listen to music etc.
There is further provided an application that provides a selection of therapies to the user and thus tells the control application which programme to apply (for example, varying the voltage, current, length of treatment, pulsing of current (time of pulse and time between pulse), etc.).
The application may allow enable the user to purchase and download additional therapy programmes. The application may enable micropayments to be taken, for example: (i) in-App pay-per use for the programmes; and (ii) download top up credits to enable the use of programmes (cf. pay-as-you-go phones).
There is provided a range of therapeutic gels that are "tuned" to particular therapy regimes, e.g. joint pain. In an embodiment, the gels are conductive and used on the site of electrode placement but not necessarily. In embodiments, the gels are sold with usage credits, e.g. code in the box, QR code etc. that enables a certain amount of credits to be downloaded, linked to a particular treatment regime in the App., e.g. enough treatments for the expected life of the purchased gel (i.e. 11 treatments if the tube of gel contains 11 applications). There is yet further provided an application that is installed on a smartphone or tablet that effectively acts as a remote control for a new or existing electronic therapeutic or diagnostic device and that:
a. provides a selection of therapies /diagnostic tests to the user, compatible with the capabilities of the target device and thus tells the control application which programme to apply (for example, varying the voltage, current, length of treatment, pulsing of current (time of pulse and time between pulse), etc.); b. enables the user to purchase and download additional therapy programmes as they are developed;
c. enables micropayments to be taken, for example:
i. in-App pay-per use for the programmes;
ii. download top up credits to enable the use of programmes (cf. pay-as-you-go phones); and
iii. top up credit vouchers/codes to be supplied with consumables (electrodes, gels , test strips etc.) to enable the device and ensure brand loyalty vs generic versions of consumables;
d. enables a recording of use to be archived / sent to care provider so that: i. care provider can verify that a prescribed therapeutic regime has been properly followed
ii. diagnostic results can be sent to a care provider - alerts could be sent.
The described methods may be implemented by a computer program. The computer program which may be in the form of a web application or 'app' comprises computer- executable instructions or code arranged to instruct or cause a computer or processor to perform one or more functions of the described methods. The computer program may be provided to an apparatus, on a computer readable medium or computer program product. The computer readable medium or computer program product may comprise non-transitory media such as as semiconductor or solid state memory, magnetic tape, a removable computer memory stick or diskette, a random access memory (RAM), a read-only memory (ROM), a rigid magnetic disc, and an optical disk, such as a CD-ROM, CD-R/W, DVD or Blu-ray. The computer readable medium or computer program product may comprise a transmission signal or medium for data transmission, for example for downloading the computer program over the Internet.
An apparatus or device may be configured to perform one or more functions of the described methods. The apparatus or device may comprise a mobile phone, tablet or other mobile processing device. The apparatus or device may take the form of a data processing system. The data processing system may be a distributed system. For example, the data processing system may be distributed across a network or through dedicated local connections. The apparatus or device typically comprises at least one memory for storing the computer-executable instructions and at least one processor for performing the computer-executable instructions.
Although aspects and embodiments have been described above, variations can be made without departing from the inventive concepts disclosed herein. For example, it
may be understood that the aspects and embodiments described above are equally suitable for the body of an animal.
Examples The inventors have found that both the application alone and in combination with an anti-ageing treatment gel reduced physical wrinkles significantly more than a control application over 8 weeks of treatment.
A randomised home -use study in three parallel groups of healthy volunteers with wrinkles was performed in order to assess the efficacy of a mobile device app on a treated site against an untreated site, and a control (inactive app). The study design along with the test groups and protocols are shown in Table 1.
Table 1
For groups 1 and 2 in Table 1 , an 'app' on a mobile telecommunications device was configured to a control a Bluetooth™ transmitter inside the mobile telecommunications device to deliver a pulsed electromagnetic field to the participants in each group every night during sleep. The frequency of the electromagnetic field itself was in the Bluetooth frequency range, 2.400 to 2.483.5 GHz. The pulsed electromagnetic field emission patterns induced by the Bluetooth transmitter were as follows:
Pulse at 13 Hz for 10 mins then off for 5 mins, this continues for 2 hours, then
Pulse at 26 Hz for 10 mins then off for 5 mins, this continues for 2 hours, then
Pulse at 39 Hz for 10 mins then off for 5 mins, this continues for 2 hours, then
End. For group 3, a dummy app was used without the knowledge of the participant.
A gel, DH3942, was applied to the skin of participants in test group 1. The components of the gel are shown in Table 2 Table 2
DH3942 Composition
Aqua
Phosphatidylcholine
Alcohol
Glycerin
Carbomer
Polysorbate 80
Disodium Phosphate
Benzylalcohol
Methylparaben
Ethylparaben
Sodium Hydroxide
Citric Acid
Linalool
Disodium Edta
Ascorbyl Palmitate
Sodium Metabisulfite
BHT
Palmitoyl Tetrapeptide-7
Palmitoyl Tripeptide-1
In addition to phospholipid vesicles, the three main components of the gel are Palmitoyl ascorbic acid (vitamin C tethered to palmitic acid), Palmitoyl tetrapeptide 7, and Palmitoyl tripeptide 1.
The purpose of vitamin C is to provide a necessary co-factor for the transformation of newly synthesised collagen. Vitamin C is part of the enzyme system that hydroxylates collagen such that it can adopt the correct 3-dimensional structure. The absence of vitamin C would mean that collagen is produced but it can't be adopted into skin structure. Given that an excess of collagen by the skin's fibroblasts is promoted there is a need for excess vitamin C to ensure the fibroblasts are convinced collagen is being degraded by the presence of the peptides.
The two peptides on the other hand promote the synthesis of collagen. In effect when fibroblasts encounter these peptides they are provoked into producing collagen since the peptides represent the breakdown products of collagen. In other words the fibroblasts have a signal that collagen is being degraded and respond by producing more collagen. It may therefore be understood that the pulsed electromagnetic field may stimulate fibroblasts to initiate production of collagen and the gel may enhance production of collagen by the fibroblasts. Conversely, the gel may stimulate the fibroblasts to initiate production of collagen and the pulsed electromagnetic field may enhance production of collagen by the fibroblasts. It may also be understood that the gel is configured to supply components of the gel to the fibroblasts and the pulsed electromagnetic field is arranged to enhance absorption of the components of the gel into the fibroblasts.
Phospholipids of the base vesicles will also be used during the production of increased sub-dermal structures since all cells require phospholipid as part of their external and internal membranes.
The reduction in wrinkle volume was assessed by profilometry. For these measurements, Silflo replicas were made of the same patch of skin on each subject at each assessment time. The volume of the ridges on these moulds - effectively the volume of the wrinkles on that patch of skin - were then measured in the following manner. A collimated light source directed at a 25° angle from the plane of the replica was used. The sampling orientation was adjusted to assess a combination of the expression-induced lines (crow's feet) and minor, fine lines. The shadow texture
produced by the oblique lighting of the negative replica was analysed. Raw data f Arppom the profilometry assessments are detailed in Table 3.
The following abbreviations are used in Table 3 and thereafter:
"Comb." = GROUP 1 : DH3942 and electromagnetic therapy app combined;
"App." = GROUP 2: electromagnetic therapy app alone;
"Control" = GROUP 3: electromagnetic therapy control app (placebo).
PROFILOMETRY
Group Week O Week 4 Week 8
131 125 118
133 127 120
-o 126 121 115
s o 135 128 123
U 127 122 116
130 124 119
136 131 123
MEAN 131.1 125.4 119.1
STDEV 3.8 3.5 3.1
Group Week O Week 4 Week 8
126 122 119
129 125 121
137 131 128
126 122 119
131 126 123
MEAN 129.8 125.2 122.0
STDEV 4.5 3.7 3.7
Group Week O Week 4 Week 8
127 129 130
129 126 127
133 131 130
o
U 125 126 127
128 127 129
MEAN 128.4 127.8 128.6
STDEV 3.0 2.2 1.5
For each type of assessment, two further variables were constructed, as detailed in Table 4, namely the difference between Week 0 and Week 4 and 8 and the ratio of Week 4 and 8 to Week 0 (normalisation).
Table 4 PROFILOMETRY
Group Week O Week 4 Week 8 WkO- WkO- Wk4/Wk0 Wk8/Wk0
Wk4 Wk8
131 125 118 6.0 13.0 0.95 0.90
133 127 120 6.0 13.0 0.95 0.90
-O 126 121 115 5.0 11.0 0.96 0.91 s o 135 128 123 7.0 12.0 0.95 0.91
U 127 122 116 5.0 11.0 0.96 0.91
130 124 119 6.0 11.0 0.95 0.92
136 131 123 5.0 13.0 0.96 0.90
MEAN 131.1 125.4 119.1 5.7 12.0 0.956 0.91
STDEV 3.8 3.5 3.1 0.8 1.0 0.01 0.01
Group Week O Week 4 Week 8 WkO- WkO- Wk4/Wk0 Wk8/Wk0
Wk4 Wk8
126 122 119 4.0 7.0 0.97 0.94
129 125 121 4.0 8.0 0.97 0.94
137 131 128 6.0 9.0 0.96 0.93 ■
126 122 119 4.0 7.0 0.97 0.94
131 126 123 5.0 8.0 0.96 0.94
MEAN 129.8 125.2 122.0 4.6 7.8 0.965 0.94
STDEV 4.5 3.7 3.7 0.9 0.8 0.01 0.00
Group Week O Week 4 Week 8 WkO- WkO- Wk4/Wk0 Wk8/Wk0
Wk4 Wk8
127 129 130 -2.0 -3.0 1.02 1.02
"o 129 126 127 3.0 2.0 0.98 0.98
¾ 133 131 130 2.0 3.0 0.98 0.98 o
u 125 126 127 -1.0 -2.0 1.01 1.02
128 127 129 1.0 -1.0 0.99 1.01
MEAN 128.4 127.8 128.6 3.0 -1.0 1.00 1.00
STDEV 3.0 2.2 1.5 2.1 2.6 0.02 0.02
The statistical significance of the results in Table 4 is shown in Table 5 for each of the test groups. In Table 5 the following conventions for levels of significance have been used:
ns p > 0.05;
* p < 0.05;
** p < 0.01;
*** p < 0.001;
**** P < 0.0001
Table 5
Figure 8 is a chart comparing reduction in wrinkle volume over 8 weeks as a percentage of wrinkle volume at week 0 (100%). The abscissa displays the number of weeks within a range from 0-8 weeks. The ordinate displays the wrinkle volume as a percentage of the wrinkle volume observed at week 0 within a range from 80-100%. The chart displays the mean data from the last two columns of Table 4. By week 8, wrinkle volume (raw data) for both the Combined treatment and the Application alone were significantly less than the Control application.
The actual differences (difference from week zero, i.e. removing any variation in week 0 data) show that at week 4 and 8, the Combination reduced wrinkle volume significantly more than both the Application alone and the Control. The Application was more effective than the Control at week 4 (nearly significantly at p= 0.054), and significantly so by week 8.
This was reflected in the normalised data where the reduction achieved by the combination (9.9%) was significantly better than the application alone (6%) which was significantly better than the Control (an increase of 0.2%) at all time points.
The application alone significantly reduces wrinkle volume over the placebo application by week 4. The addition of an anti-wrinkle gel formulation significantly enhances the effect of the application by week 8.