Various studies on skin rejuvenating methods and their effects

Autologous fibroblasts are good sources for correcting the appearance of aging and wrinkles by replacing lost skin components and playing a crucial role in healing.


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Original studies on acne and wrinkle treatment with autologous fibroblasts
Detailed description of studies, procedures, methods and their results
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Studies on the efficacy of autologous fibroblasts in skin rejuvenation and skin repair

P2810

Two phase III, multicenter, double-blind, randomized, placebo-controlled trials evaluating the efficacy and safety of autologous fibroblast therapy in the treatment of nasolabial fold wrinkles

 

Stacy R. Smith, MD, San Diego, CA, United States

 

Background: AT (Isolagen Technologies, Inc. Exton, PA) is a rejuvenation technology utilizing a patient’s own cultured cells to induce tissue repair and regeneration. The experience in the United States to date (;100 clinicians treating ;1000 patients) has been encouraging involving facial rhytids. This led to two confirmatory phase III studies (005/006) comparing AT to placebo (P) in the treatment of NLF under a FDA Special Protocol Assessment (SPA). Additional study controls included patient selection, cell biopsy, time frame for use, injection and assessment training, separate injectors and blinded assessors, and evaluation standards defined under this SPA to confirm AT’s efficacy and safety.

 

Methods: Two identical, double-blind, parallel, multicenter, phase III studies were initiated to compare the efficacy and safety of AT versus P in the treatment of moderate to severe NLF wrinkles. Subjects over the age of 18 years in whom cosmetic treatment was indicated for NLF wrinkles ([3 on 6 point Lemperle scale) were randomized to AT or placebo in a 1:1 ratio. Subjects underwent small punch biopsies of the retroauricular skin to process isolated fibroblasts. These cells were serially cultured resulting in a suspension of 1-2 3 107 viable cells/ mL. Subjects then received three injection treatments, 30 7 days apart. Injections of 0.1 mL/linear cm (\2 mL/treatment) into the papillary dermis of 2 BNL (\20 cm combined) were given by a trained physician. A separate blinded physician, as well as the subjects, evaluated their NLF wrinkles at baseline (BL), 2, 4, and 6 months post-final treatment. Physician graders utilized the Lemperle Rating Scale, a previously published, static, 6-point photonumeric scale to assess NLF wrinkle severity. The proportion of subjects achieving various degrees of improvement in their NLF wrinkle scores were compared between groups. Safety information was collected via regular examinations and collection of reported adverse events.

 

Results and conclusions: A total of 421 subjects were randomized in the 2 studies: 203 subjects with a mean age of 57.3 years in 005 and 218 subjects with a mean age of 55.0 years in 006. In 005 subjects were 89.6% female and 88.17% white; in 006, subjects were 90.8% female and 87.6% white. Populations were comparable between studies and observations between AT and placebo will be discussed.

Supported by Isolagen Techologies, Inc.



Studies on the effectiveness of hyaluronic acid in skin rejuvenation and skin repair

The use of hyaluronic acid gel to treat uncommon areas of the face

Luciana Godoi Correa, MD, Clinica Nuno Osorio, São Paulo, Brazil; Ane Beatriz Niwa, Clinica Nuno Osorio, São Paulo, Brazil; Luis Antonio Torezan, MD, Clinica Nuno Osorio, São Paulo, Brazil; Nuno Osorio, MD, Clinica Nuno Osorio, São Paulo, Brazil

 

Hyaluronic acid gel has been used by Brazilian dermatologists for years to correct wrinkles, augmenting the lips, and shaping its countours. It is a safe material, with immediate results. No tests before treatment are required. Adverse reactions are very rare because it does not contain animal protein and its effect is not permanent. In this poster, we relate the use of hyaluronic acid gel to fill and shape uncommon areas of the face.

 

We describe 4 cases where hyaluronic acid gel was used to fill the dark circles around the eye, 5 cases where it was used to fill the ear lap. In all cases, the cosmetic result was excellent. Among the few complication levels, ecchymosis was the one that occurred the most. The exact duration of this treatment is currently unknown.