Cellulite injection: clinical studies continue
In the second half of 2013, researchers at Stony Brook University, working under the guidance of Professors Marie A. Badalamente and Alexander B. Dagum, plan to start a placebo-controlled clinical trial of Phase IIa of a pharmacological method of cellulite treatment developed by them. Licensed by BioSpecifics Technologies and sublicensed by Auxilium Pharmaceuticals, this method is based on the use of a form of the collagenase enzyme intended for subcutaneous administration.
To date, there is not a single method approved by the US Food and Drug Administration for the treatment of cellulite – a condition that is not a disease, but a common cosmetic defect that affects up to 90% of women and about 10% of men.
With cellulite, the skin of problem areas (thighs, buttocks, abdomen) takes the form of a so–called orange peel - it is covered with characteristic pits and bumps, the cause of which is the pressure of fat deposits on the collagen fibers of connective tissue.
The principle of action of the experimental collagenase preparation is the enzymatic dissolution of collagen fibers stretched by fat deposits, which ensures the alignment of the skin relief.
As part of a phase I pilot clinical trial, collagenase was injected into the posterior surface of the thighs of 10 women. Before the procedure, the cellulite areas were measured in square centimeters and photographed. On average, experimental therapy provided a 77% reduction in the severity of cellulite within a day after the introduction of collagenase. At the same time, women noted only minor side effects, such as bruising, soreness and slight redness of the skin immediately after administration of the drug. 6 months after the procedure, the positive effect of its implementation remained on average at the level of 76%. At the same time, the average level of satisfaction of the study participants with the results of therapy was 1.75 (1 – complete satisfaction, 4 – dissatisfaction).
According to the authors, currently quite a lot of approaches are used to combat cellulite, including laser therapy, massage and creams for topical application, but their effectiveness is not supported by convincing evidence. They hope that the introduction of collagenase will prove to be a safe and effective alternative, ensuring stable results.
Evgeniya Ryabtseva
Portal "Eternal youth" http://vechnayamolodost.ru based on the materials of Stony Brook University:
Clinical Trials for Cellulite Treatment on the Horizon.
Portal "Eternal youth" http://vechnayamolodost.ru17.04.2013