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Scientific Proof

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Unlike the competition Clevagen INTENSIV contains the
recommended concentration of 5% VOLUFILINE™.

VOLUFILINE™
Patent filed For a progressively
shapelier bust

The efficacy of VOLUFILINE™ in promoting the installation of fat has beendemonstrated in vitro and in vivo. The results of the studies are reported in thisdossier.

The cells incubated in the presence of VOLUFILINE™ showed an increase indose-dependent lipid incorporation that was greater than 492% vs. thecontrol cells, for a VOLUFILINE™ concentration of 1.75%.

The results were reproduced using human adipocytes:

Following culture and confluence, the human adipocytes were incubated in the differentiation maintenance medium in the absence (control) or presence of VOLUFILINE™at various concentrations for 6 days.

At the end of that period, the cells were washed, fixed and stained with red oil. The cell layers were digitally photographed and the red staining quantified by image analysis.

Photographs of human adipocytes:


Figure a: control


Figure b: 0.5%VOLUFILINE™


Figure c: 1% VOLUFILINE™

 

The mean cell volume was increased 26-fold in 6 days vs. the control cells, as
illustrated by the 3D-confocal microscopy images shown hereafter:


Adipocytes before


Adipocytes after

Conclusion of the in vitro studies
The set of results obtained show complete consistency between the DNA array activated-gene profile and the cell effects observed. VOLUFILINE™ maintained a moderate proliferative activity throughout the differentiation phase: 20 to 35%.
VOLUFILINE™ amplified differentiation (430% increase) and maintained it, activating lipid accumulation (640% increase). Those effects result in a volume-enhancing effect on adipose tissue, which was demonstrated by confocal microscopy.

Principle
The volume study was conducted using interference-fringe topometry consisting in analysis of the optical deformation of the fringes projected on the skin surface under laser illumination (FOITS method).

A clinical trial conducted on 28 female volunteers with a small bust (FOITSmethod) demonstrated a gradual volume-enhancing effect after 28 and 56days of 5% VOLUFILINE™ application.

Protocol
For this study in order to ensure the most precise repositioning possible, it was necessary to develop special equipment consisting in:
- a horizontal breast support system (identical to that used for breast radiography) the height of which was precisely determined relative to the seat
- a back-rest system situated at a constant distance from the breast-rest.

The system is shown below:

Study type
Single-blind controlled study, treated breast vs. untreated breast. The treated breast was the left or right breast (randomization of the study population).

Number of subjects:
32 subjects included. 30 completed the study.
Only 28 cases were evaluable at time point 56 days.

Special study criteria
Women aged 18 to 35 years
Small breast volume, cup size 80-85B or 90A
Regular hormonal status or status stabilized by oral contraceptives. No pregnancy or breast-feeding during the study. Body weight stable for at least 3 months.

Product application
The product was a cream gel containing 5% VOLUFILINE™ (Appendix 1), which
was applied twice daily for 56 days.

Results

Safety
The product was well tolerated by all the volunteers.

Out of the 32 volunteers included in the study, only the data for n=30 subjects at time point 28 days and n=28 subjects at time point 56 days were evaluable.

The breast volume determined by FOITS was that of the superior part of the breast (décolleté zone), the lower part being excluded by the positioning system.

For the control breast, the change in volume was practically null after 28 days and the very slight variation observed at 56 days was of very little significance (p=0.52). For the treated breast, an increase, although not very significant, was observed at T28 (p=0.3). The increase was confirmed at T56 days with 90% certainty (p=0.1).

 

Table 7
Percentage change in breast volume after 5% VOLUFILINE™ application for 56 days
Mean values for n=28 subjects and for the best responders (n=8).

For the entire population, i.e. 28 subjects, an increase in breast volume was observed for the VOLUFILINE™-treated breast and that increase became more marked over time: 1.4 to 2.2%. As indicated above, the increase at T56 was 90% certain (p=0.1).

The percentage increases for the best responders (8 subjects) were 5.6 and 8.4% at T28 and T56.

Conclusion
While the increase in breast volume was moderate: on average 2.2% at time point 56 days for the 28 subjects, they were nonetheless significant at the p=0.1 level.

This trend toward an increase, which became more marked over time, is a second indication that concords with the results obtained and suggests that the long-term results may be even better.

 

 


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