Autologous Cells Improve Acne Scarring

WASHINGTON – The autologous cellular product azficel-T produced significant improvement in acne scarring compared with placebo, according to new study results reported at the annual meeting of the American Society for Dermatologic Surgery.

The product, Laviv (Fibrocell Science), was recently approved by the Food and Drug Administration for the treatment of moderate to severe nasolabial folds. It is the first FDA-approved personalized cell therapy for aesthetic use, according to Dr. Girish Munavalli of the dermatology department at Wake Forest University, Winston-Salem, N.C.

In the multicenter, randomized, double-blind, placebo-controlled study, skin biopsies were collected from 119 patients with moderate-to-severe depressed acne scarring of at least 9 cm² for at least 3 years. The biopsies were used to produce individual fibroblasts for each patient. Up to three injections of 2 mL of autologous fibroblasts (10-20 million cells/mL) were given on one cheek and placebo on the other at 14-day intervals in 99 of the patients. Treatment was administered at a dose of 0.1 mL/cm² into areas of acne scarring. Adverse events were recorded for each cheek.

At 4 months after completion of the treatment, a statistically significant higher percentage of patients had responded to treatment with azficel-T than to treatment with placebo, as rated by both the study investigators (58.7% vs. 42.2%, respectively) and patients (43.1% vs. 18.3%). Patient and evaluator assessments at earlier time points during the study also showed a significantly higher proportion of responses with azficel-T than with placebo at all but one assessment, reported Dr. Munavalli.

The study successfully met its two prospectively defined end points: a 2-point or greater improvement on a 5-point Subject Live Acne Scarring assessment scale, and a 1-point or greater reduction in cheek acne severity on a physician-assessed, validated 5-point Evaluator Live Acne Scar assessment scale.

All reported adverse events were mild or moderate in severity. No subjects experienced serious adverse events, discontinued treatment, or withdrew from the study. The incidence of adverse events occurring in the treatment areas was comparable between azficel-T and placebo. The most commonly reported adverse events were treatment-area erythema (occurring in 11.1%) and swelling (10.1%). In the azficel-T-treated area, erythema was moderate in 5 of the 12 subjects who reported it, and swelling was moderate in 5 of the 11 who reported it. In contrast, all treatment-related adverse events in the placebo-treated areas were mild.

Other adverse events with a possible relationship to study treatment included bruising, rash, irritation, nodules, pain, acne, induration, and headache, Dr. Munavalli reported.

"Our findings show that using a person's own collagen-producing cells in the form of Laviv may provide a promising new alternative to improve acne scarring with minimal downtime and an excellent safety profile," he noted.

Dr. Munavalli received research funding from Fibrocell Science.

WASHINGTON – The autologous cellular product azficel-T produced significant improvement in acne scarring compared with placebo, according to new study results reported at the annual meeting of the American Society for Dermatologic Surgery.

The product, Laviv (Fibrocell Science), was recently approved by the Food and Drug Administration for the treatment of moderate to severe nasolabial folds. It is the first FDA-approved personalized cell therapy for aesthetic use, according to Dr. Girish Munavalli of the dermatology department at Wake Forest University, Winston-Salem, N.C.

In the multicenter, randomized, double-blind, placebo-controlled study, skin biopsies were collected from 119 patients with moderate-to-severe depressed acne scarring of at least 9 cm² for at least 3 years. The biopsies were used to produce individual fibroblasts for each patient. Up to three injections of 2 mL of autologous fibroblasts (10-20 million cells/mL) were given on one cheek and placebo on the other at 14-day intervals in 99 of the patients. Treatment was administered at a dose of 0.1 mL/cm² into areas of acne scarring. Adverse events were recorded for each cheek.

At 4 months after completion of the treatment, a statistically significant higher percentage of patients had responded to treatment with azficel-T than to treatment with placebo, as rated by both the study investigators (58.7% vs. 42.2%, respectively) and patients (43.1% vs. 18.3%). Patient and evaluator assessments at earlier time points during the study also showed a significantly higher proportion of responses with azficel-T than with placebo at all but one assessment, reported Dr. Munavalli.

The study successfully met its two prospectively defined end points: a 2-point or greater improvement on a 5-point Subject Live Acne Scarring assessment scale, and a 1-point or greater reduction in cheek acne severity on a physician-assessed, validated 5-point Evaluator Live Acne Scar assessment scale.

All reported adverse events were mild or moderate in severity. No subjects experienced serious adverse events, discontinued treatment, or withdrew from the study. The incidence of adverse events occurring in the treatment areas was comparable between azficel-T and placebo. The most commonly reported adverse events were treatment-area erythema (occurring in 11.1%) and swelling (10.1%). In the azficel-T-treated area, erythema was moderate in 5 of the 12 subjects who reported it, and swelling was moderate in 5 of the 11 who reported it. In contrast, all treatment-related adverse events in the placebo-treated areas were mild.

Other adverse events with a possible relationship to study treatment included bruising, rash, irritation, nodules, pain, acne, induration, and headache, Dr. Munavalli reported.

"Our findings show that using a person's own collagen-producing cells in the form of Laviv may provide a promising new alternative to improve acne scarring with minimal downtime and an excellent safety profile," he noted.

Dr. Munavalli received research funding from Fibrocell Science.

WASHINGTON – The autologous cellular product azficel-T produced significant improvement in acne scarring compared with placebo, according to new study results reported at the annual meeting of the American Society for Dermatologic Surgery.

The product, Laviv (Fibrocell Science), was recently approved by the Food and Drug Administration for the treatment of moderate to severe nasolabial folds. It is the first FDA-approved personalized cell therapy for aesthetic use, according to Dr. Girish Munavalli of the dermatology department at Wake Forest University, Winston-Salem, N.C.

In the multicenter, randomized, double-blind, placebo-controlled study, skin biopsies were collected from 119 patients with moderate-to-severe depressed acne scarring of at least 9 cm² for at least 3 years. The biopsies were used to produce individual fibroblasts for each patient. Up to three injections of 2 mL of autologous fibroblasts (10-20 million cells/mL) were given on one cheek and placebo on the other at 14-day intervals in 99 of the patients. Treatment was administered at a dose of 0.1 mL/cm² into areas of acne scarring. Adverse events were recorded for each cheek.

At 4 months after completion of the treatment, a statistically significant higher percentage of patients had responded to treatment with azficel-T than to treatment with placebo, as rated by both the study investigators (58.7% vs. 42.2%, respectively) and patients (43.1% vs. 18.3%). Patient and evaluator assessments at earlier time points during the study also showed a significantly higher proportion of responses with azficel-T than with placebo at all but one assessment, reported Dr. Munavalli.

The study successfully met its two prospectively defined end points: a 2-point or greater improvement on a 5-point Subject Live Acne Scarring assessment scale, and a 1-point or greater reduction in cheek acne severity on a physician-assessed, validated 5-point Evaluator Live Acne Scar assessment scale.

All reported adverse events were mild or moderate in severity. No subjects experienced serious adverse events, discontinued treatment, or withdrew from the study. The incidence of adverse events occurring in the treatment areas was comparable between azficel-T and placebo. The most commonly reported adverse events were treatment-area erythema (occurring in 11.1%) and swelling (10.1%). In the azficel-T-treated area, erythema was moderate in 5 of the 12 subjects who reported it, and swelling was moderate in 5 of the 11 who reported it. In contrast, all treatment-related adverse events in the placebo-treated areas were mild.

Other adverse events with a possible relationship to study treatment included bruising, rash, irritation, nodules, pain, acne, induration, and headache, Dr. Munavalli reported.

"Our findings show that using a person's own collagen-producing cells in the form of Laviv may provide a promising new alternative to improve acne scarring with minimal downtime and an excellent safety profile," he noted.

Dr. Munavalli received research funding from Fibrocell Science.