BEST CELLULITE TREATMENT

INVEL ACTIVE THERAPEUTIC SHORTS
WITH BIOCERAMICS® MIG3®  

1. Clinical study published in the Journal of Drugs in Dermatology, USA, using Bermuda Invel® for 8 hours daily for 30 days. 2. Randomized, double-blind study of 151 women using Bermuda Invel® with MIG3® technology for 60 days, for 8 hours a day. (Study of nitric oxide) Evaluation of the effect of fabrics incorporated with Bioceramics® MIG3® Invel®, on the generation of NO gas. São Paulo, v.00, 69 p., 2010.

Randomized, double-blind clinical study evaluating the improvement of gynoid lipodystrophy (cellulite) with the use of Bermuda Invel® Activive Shorts.

Regina Mayumi Doi1, Marcos Leal Brioschi2, Cicília Yuko Wada3

1L.AL Clínica Pesquisa e Desenvolvimento Ltda; 2InfraRedMed – Infrared Diagnosis; 3 Statpharm Scientific Advisory

Introduction

Gynoid lipodystrophy (GLD) is a complex of changes in adipose tissue, resulting in macronodules on the skin surface. It is an important factor related to aesthetics and female self-esteem, which searches for effective and safe treatment methods relevant. It affects between 85 and 98% of women after puberty(1) and is characterized by changes in skin topography, causing small depressions in the skin, whose appearance becomes similar to orange peel. The Curri scale, the most used, classifies the degree of lipodystrophy into four evolutionary degrees divided by its intensity of involvement(2)

goal

Primary: – Evaluate the clinical improvement of the areas affected by Gynoid Lipodystrophy (cellulite), through clinical (physical examination) and laboratory parameters (assessment of elasticity).
Secondary: – Evaluate, with the help of Infrared Thermography, the evolution of peripheral microcirculation in the area affected by Gynoid Lipodystrophy. – Evaluate the safety of using the product.

Methodology

A randomized, double-blind, placebo-controlled, single-center national study was carried out, including a sample of 151 volunteers with grade III Gynoid Lipodystrophy (cellulite) in at least one of the areas evaluated, from April to June 2009. Investigational

product: Invel® Active Shorts Traditional.

Methodology

The Invel® Active Shorts Traditional as well as the placebo Bermuda shorts were used for 60 days, for at least eight consecutive hours. Follow-up assessments were carried out at 30 (first visit) and 60 (second visit) days.

Assessment method:

(a) The Curri scale: Visual classification of lipodystrophy; (b) MPA580 Customer®: Skin elasticity; (c) Infrared thermography in chemistry and in the evaluation of procedures in aesthetic medicine constitutes another method, although it is not a recent phenomenon; (d) Product safety was measured by the proportion of patients who did not experience adverse events, serious or not, related to the use of the product.

Results

Cellulite Degrees:

Significant differences in the proportions of improvements in cellulite grades II and III on the Curri scale between Invel® Active Shorts Traditional and Placebo on the Buttock over 30 days, in the difference tests (p=0.01623) and ratio (p=0.00644). The estimate of the relative risk of improving the degree of cellulite within 30 days in the Buttocks was RR=2.107, which indicates that treatment with Bioceramica® is 111% superior to placebo.

Elasticity:

There was a significant effect of time on elasticity in all locations and sides, at a significance level of 5%.

Thermography :

The effects of time were significant in all places studied, that is, the average temperatures at the three times differ significantly, at a significance level of 5%.

Safety:

No clinically significant events were observed in the studied population.

Greater tissue irrigation, decreased area of ​​lesser irrigation, increased perfusion Homogeneously:

Conclusion

With the use of Invel® Active Shorts Traditional for 8 hours of use daily, for 60 days, the present study demonstrated an average improvement of 19% in the clinical aspect of cellulite (gynoid lipodystrophy) grade II and III according to the scale by Curri. Invel® Active Shorts Traditional with Invel® technology did not cause irritation and/or sensitization in research subjects, which demonstrates that it is a safe product for use under the conditions in which they were tested. ANVISA, the National Health Surveillance Agency, recognized the efficacy and safety of this product and granted ANVISA/MS registration N°80104760003 on 01/31/2011.

Reference

1. Avram MM. Cellulite: a review of its physiology and treatment. J Cosmet Laser Ther 2004; 6:181-185. 2. Curri SB. Las paniculopathies of venous striae: clinical and instrumental diagnosis. Barcelona: Hausmann, 1991.p.211.

Acknowledgment

This research was sponsored by INVEL® (GOEN3 Indústria e Comércio de Artigos para a Saúde Ltda), and the company that carried out the clinical monitoring of the study, hired by the sponsor, was ProSearch Pesquisa Clínica. Research developed by IITP® (Invel Institute of Technology and Research).

Journal of Drugs in Dermatology - New Methods and techniques

A double-blinded, randomized trial testing the tolerability and efficacy of an innovative topical agent with or without occlusion for the treatment of cellulite: a study and literature review.

Rao J, Paabo Ke, Goldman MP. Dermatology/Cosmetic Laser Associates of La Jolla, Inc., La Jolla, California 92037, USA.

SUMMARY

In a scientific article published in the Journal of Drugs in Dermatology, New York, researchers prove the effectiveness of the tissue incorporated with Bioceramics. A group made up of 20 volunteers with a moderate degree of cellulite received treatment with tissue occlusion on one of the thighs. In the other, an anti-cellulite cream was applied to the affected areas regularly at night. After a period of four weeks, evaluating dermatologists detected an improvement of up to 65% in thighs treated with Bioceramics.

The result was obtained by comparing photographs taken from various angles before and after the study. Among the volunteers, 17 completed evaluations about the test. For 76%, it was possible to notice an improvement in cellulite, of which 54% reported that the improvement was on the thigh that received the item of clothing. Using the photographs, the evaluators also detected an improvement of 59% in the thighs treated without occlusion.

Publications: Clinical Experiments Randomized Controlled Experiments