Efficacy Test Conducted With ByeByeCellulite Cream

ByeByeCellulite Cream was found to statistically significantly enhance the biomechanical properties of the skin on the thigh towards the firm-elastic optimum. After 28 days of treatment, a mean increase by 9% (firmness) / 10% (elasticity) was observed and a positive effect of the Anti Cellulite Cream was detected in 85% (firmness) and 90% (elasticity) of the volunteers.

Skin Roughness
Cellulite Cream was found to statistically significantly increase smoothness on the thigh. After 28 days of treatment, a mean increase by 11% was observed and a positive effect of the Anti Cellulite Cream was detected in 90% of the volunteers.

Thigh Circumference
No significant effect of the cream for cellulite on thigh circumference could be observed over the course of the Cellulite treatment.

ByeByeCellulite Cream – Professional Scoring of Cellulite Symptoms

Use of the Anti Cellulite Cream was found to significantly reduce the cellulite symptom score. After 28 days of treatment, a positive effect on the cellulite symptom score was observed in 65% of volunteers.

Methods
Measurement of Biomechanical Properties (Elasticity, Firmness)

The biomechanical properties of the skin are assessed using the Cutometer MPA580

The measurement is based on the vacuum-suction principle. By applying a constant negative pressure for a given time period, skin is drawn into a hollow tube with an orifice of 2 mm in diameter. Then, at normal air pressure, the skin is allowed to retract. The penetration depth of the skin into the tube is recorded optically without friction and without mechanical influence.

A number of standardized parameters can be calculated from the resulting penetration depth curve. Most of the parameters are a function of skin thickness and thus cannot be simply compared between subjects and regions.
To increase accuracy and to capture information on the properties of skin under repeated external stress, the cycle is repeated several times and parameters selected for evaluation are based on areas rather than individual measurement points.

The delineation of the areas is based on the fitted logarithmic envelope curves of the minimum and maximum extensions according to the equation:

y= ln x + b : a

(x = repetitions, y = max. amplitude or min. amplitude).

The study was conducted with 20 successive measurement cycles, 1 second suction, 1 second retraction, with a 450 mbar vacuum. The following parameters were selected to assess changes in the biomechanical properties of the skin:

ByeByeCellulite Cream Measurements of Elasticity and Firmness

Fig. 1: Cutometer Parameters

The study was conducted with 20 successive measurement cycles, 1 second suction, 1 second retraction, with a 450 mbar vacuum. The following parameters were selected to assess changes in the biomechanical properties of the skin:

Skin firmness
Skin firmness is assessed by the parameter F4, the area below the approximated envelope function of the maximum extensions.  A decrease in F4 corresponds to an increase in skin firmness.

Skin elasticity
Skin elasticity is assessed by the ratio F3 / F4. The larger F3 in comparison to F4, the larger are the restoring forces and the smaller is the remaining residual deformation.  The closer the resulting value is to 1, the more elastic the skin.

The calculation of the parameters was conducted by WinCT (Courage & Khazaka GmbH, Cologne – Germany).

Measurement of Skin Roughness

PRIMOS (Phase-Shifting rapid in vivo measurement of skin) is a non-contact measurement device, which allows for real-time three dimensional in vivo measurement of the micro topography of human skin based on the technology of active image triangulation. The measurement head consists of a digital micromirror device as projection unit and a CCD-camera as recording unit, mounted onto an adjustable rack.

For active image triangulation an intensity encoded point M is projected onto the surface under investigation. Its image on the surface is recorded by the CCD-camera from a specific angle. The point M is a function of parameters like intensity, triangulation angle between projection system and camera and some other inner respectively outer coordinates of the camera and projection plane.

The height information of the structured surface is coded in the distorted intensity pattern, which is recorded. The resolution and accuracy depends on the optical and topographical characteristics of the measured surface and on the noise characteristics of the measurement system. For accurate in vivo measurements of human skin, depending on the measured part of the human body (inner forearm, forehead, eye zone), different parameters of effective wavelength and amplification factor should be used.

The skin surface of the thigh is recorded from silicon imprints as a 3D topography using the PRIMOS system – the fast phase-shift technique was used for the measurement (phase width: 16 & 64 pixels). The silicon imprints (Detaseal Xlite, Detax GmbH & Co. KG, Germany) of the thigh were taken with a diameter of approximately 5 cm diameter (PRIMOS measurement centrally on the imprint).

The macro-structure of the area was digitally removed by a polynomial filter and, if necessary, areas with questionable reproductive character (air bubbles) excluded from the evaluation. Skin roughness was then assessed by means of the parameter RZ (mean depth of roughness). To mitigate potential directional effects, the evaluation was conducted using the arithmetic average of RZ from 32 radial cuts.

Professional Scoring of Cellulite Symptoms

Two trained evaluators graded the level of cellulite symptoms using a 5-point scale (0-4). Ambient conditions for the evaluation were standardized (artificial light source: LUMILUX 840 fluorescent tubes, 4000K cool white with excellent colour accuracy) and subjects asked to stand upright and to maintain a neutral expression during the evaluation. The evaluators made their rating independently inspecting the subjects from all angles. Analysed are their mean scores for each of the two treatment conditions. The scale used is based upon the 4 stages of cellulite:

0 = no signs
1 = slight dimpling of skin surface
2 = dimpling and skin depressions
3 = dimpling and depressed striations
4 = palpable nodules and striations

Thigh Circumference
The thigh circumference was measured under standardized conditions standing upright with a tape measure (tape measure was put around the thigh, pressed together and released, retracted until the measure could move without friction over the thickest point of the thigh) and recorded in 0.5cm intervals.

Performance of Test
The subjects were selected from the Derma Consult Concept GmbH database. They were informed about importance and meaning of the study; they could withdraw from the study at any time without giving any reason. Written informed consent was obtained from all the subjects prior to entry into the trial. The following criteria were used for selection of subjects:
for inclusion in study:

– female (≥ 18 years of age)
– ability to comply with the requirements of the study
– fundamentally clinically healthy
– cellulite grade: 3 – 4 (see scale above)

for exclusion from study:

– skin diseases or any other medical condition interfering with the objectives of the study
– planned medical treatment during study period
– pregnancy
– past surgery in the test areas
– weight-loss diet within past 3 month
– change or start of hormone replacement therapy within past 3 month
– change or start of oral contraception within past 3 month

A reserve subject in addition to the 20 original subjects, to replace potential drop-outs, started the study with a delay of 1 day (final readings only taken in case a drop-out needed to be replaced).

The subjects were instructed not to use any topical preparations on the test areas starting from seven days prior to testing (preconditioning phase) and until the end of the test. For cleansing, water or a mild syndet (Eubos® flüssig – blau; manufacturer: Dr. Hobein, D-53340 MeckenheimMerl, Germany) was allowed only (whole study inclusive the preconditioning phase).

The subjects were asked to maintain their current sporting habits and nutrition throughout the study, not to use tanning beds and to report any medical treatment / medication to the study supervisor. For visits to the test institute, the subjects were instructed not to wear stretching clothes or underwear (to avoid leaving marks on the skin), not to visit saunas or swimming pools and not to consume alcohol within 24 hours before measurement / scoring.

Prior to the first application of the ByeByeCellulite Cream on the initial study visit to the test institute after the preconditioning phase, the cellulite grade of each thigh was assessed by two trained evaluators independently (scores averaged) and subsequently biomechanical properties measurements and silicon imprints were taken at clearly defined sites on each thigh and thigh circumference was measured. The exact measurement sites (defined and assessed in upright, standing position), selected as areas with the most defined symptoms, were recorded for each subject for later relocation.

The silicon imprints (Detaseal Xlite, Detax GmbH & Co. KG, Germany) were taken with a diameter of approximately 5 cm (PRIMOS measurement centrally on the imprint). One thigh (randomized selection) remained untreated and served as control. Further scoring, measuring and imprinting was performed after 28 days of regular treatment 8-12 hours following the final application before the concluding visit.

After a detailed explanation of the correct product application procedure by a Derma Consult staff member on the first study visit to the test institute after the preconditioning phase, the subjects used the Anti Cellulite Cream twice daily (in the morning and evening) after cleansing at home according to the on-pack instructions (supplied by the study sponsor) – massaging the ByeByeCellulite Cream into the skin of the designated treatment thigh with light pressure, starting with only a small amount of Anti Cellulite Cream, increasing it over time.

The subjects were expressly advised about the specific characteristics of the ByeByeCellulite Cream with possible minor discomfort in the form of reddening, feeling of warmth or stinging at the beginning of the treatment and to reduce the application amount, if required, to minimize these symptoms. Additionally as precaution, they were instructed not to use the cream for cellulite immediately after bathing.

The first application was performed at the test institute after cleansing with wet towels under supervision of a Derma Consult staff member to ensure proper use. All measurements and scoring were conducted after adaptation to the controlled environmental conditions of the test institute (room temperature: 21±1°C, relative humidity: 45±5%).

Biometry
Measurement data is automatically computerised and after validity check and quality assurance stored centrally in a database. Evaluation is conducted using the software NAG® Statistical AddIns for Excel – NAG Ltd., United Kingdom. The data were analyzed by Wilcoxon Rank Test. The 0.05 level was selected as the point of minimal acceptance of statistical significance.

Results
During the first week of treatment, original subject 16 chose to drop out of the study due to experienced discomfort (see incompatibility section below) and was replaced by the reserve subject. The data collected on the initial visit from the drop-out was discarded and hence the entire evaluation is based on the results from 20 completing volunteers, aged between 38 -59 years (average: 47,5).

Biomechanical Properties (Skin Firmness / Skin Elasticity)
In assessing skin firmness, evaluated are changes in the parameter F4 in the treated condition (thigh) in comparison to the changes in the untreated condition. The absolute values by condition and time point are shown below in figure two; the changes from the initial condition in figure three. A decrease in F4 corresponds to an increase in skin firmness.

Experimental data of Skin Firmness Fig. 2: F4 Values

ByeByeCellulite Cream Experimental data of Skin Firmness

 

Increase in Skin Firmness relative to initial conditions and to untreated Fig. 4

After 28 days of treatment, a statistically significant (p<0.05) decrease in F4 was observed in the product treated condition as compared to the changes in the untreated condition. The cream for cellulite was found to statistically significantly increase skin firmness.

After 28 days of treatment a positive effect could be detected in 85% of the study participants. The respective percentage changes as compared to the initial condition and with regard of the changes in the untreated condition are shown in figure four below.

Experimental data of Skin Firmness (delta values) Fig. 3: F4 Values

ByeByeCellulite Cream Experimental data of Skin Firmness (delta values)
ByeBye Cellulite Cream Increase in Skin Firmness in %

In assessing skin elasticity, evaluated are the changes in the fraction F3 divided by F4 in the treated condition in comparison to the changes in the untreated condition. The absolute values by condition and time point are shown below in figure five; the changes from the initial condition in figure six. An increase in F3/F4 corresponds to an increase in skin elasticity.

Experimental data of Skin Elasticity Fig. 5: F3/F4 Values

ByeByeCellulite Cream Experimental data of Skin Elasticity

 

Increase in Skin Elasticity relative to initial conditions and to untreated Fig. 7

After 28 days of treatment, a statistically significant (p<0.05) increase in F3/F4 was observed in the product treated test condition as compared to the changes in the untreated condition.

The ByeByeCellulite Cream was found to statistically significantly increase skin elasticity; after 28 days of treatment a positive effect could be detected in 90% of the study participants. The respective percentage changes as compared to the initial condition and with regard of the changes in the untreated condition are shown in figure seven below.

Experimental data of Skin Elasticity (delta values) Fig. 6: F3/F4 Values

ByeByeCellulite Cream Experimental data of Skin Elasticity (delta values)
ByeByeCellulite Cream Increase in Skin Elasticity in %

The ByeByeCellulite Cream was found not only to increase skin firmness, but at the same time to also increase skin elasticity. Overall, the ByeByeCellulite Cream induced a change in the biomechanical properties of the skin on the thigh towards the firm-elastic optimum.

The Cream for Cellulite was found to statistically significantly increase skin smoothness; after 28 days of treatment a positive effect could be detected in 90% of the study participants.

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