Jwala Karnik1, Leslie Baumann2, Suzanne Bruce3, Valerie Callender4, Steven Cohen5, Pearl Grimes6, John Joseph7, Ava Shamban8, James Spencer9, Ruth Tedaldi10, William Philip Werschler11, Stacy R Smith12. 1. Suneva Medical Inc, Santa Barbara, California. 2. Baumann Cosmetic and Research Institute, Miami, Florida. 3. Suzanne Bruce and Associates, Houston, Texas. 4. Callender Dermatology and Cosmetic Center, Glenn Dale, Maryland; Howard University College of Medicine, Washington, District of Columbia. 5. FACES+ Plastic Surgery, Skin, and Laser Center, San Diego, California; Division of Plastic Surgery, University of California, San Diego, California. 6. Vitiligo & Pigmentation Institute of Southern California, University of California, Los Angeles Geffen School of Medicine, Los Angeles, California. 7. Clinical Testing Center of Beverly Hills, CA, University of California, Los Angeles, Geffen School of Medicine, Los Angeles, California. 8. University of California, Los Angeles, Geffen School of Medicine, Los Angeles, California. 9. Mount Sinai School of Medicine, New York, New York. 10. private practice, Wellesley, Massachusetts. 11. Division of Dermatology University of Washington School of Medicine, Seattle, Washington. 12. Division of Dermatology, University of California, San Diego, California. Electronic address: ssmith@stacyrsmithmd.com.
Abstract
BACKGROUND: Acne scarring remains a stubborn clinical problem. Few treatments have been shown to be definitely effective for this problem. Polymethylmethacrylate (PMMA) microspheres in collagen (ArteFill, Suneva Medical Inc, Santa Barbara, CA) have shown long-term benefit for nasolabial fold treatment. A pilot study has shown benefit for PMMA-collagen in atrophic acne scarring. OBJECTIVE: We sought to demonstrate the safety and effectiveness of PMMA-collagen for acne scarring in a controlled, blinded trial. METHODS:Subjects with at least 4 moderate to severe rolling, atrophic scars randomly receivedPMMA-collagen or saline injections. Subjects underwent up to 2 injection sessions and were followed up for 6 months. Efficacy was assessed using a validated rating scale for each scar. RESULTS: In all, 147 subjects underwent injections. Success was achieved by 64% of those treated with PMMA-collagen compared with 33% of control subjects (P = .0005). The treatment showed excellent safety with generally mild, reversible adverse events. No significant differences in efficacy or safety were noted between genders, for darker skin types, or in older age groups. LIMITATIONS: Subjects were followed up for only 6 months. CONCLUSION:PMMA-collagen demonstrates substantial effectiveness in the treatment of atrophic acne scars of the face while maintaining an excellent safety profile. Further follow-up should be undertaken to demonstrate longer-term benefit and safety.
RCT Entities:
BACKGROUND: Acne scarring remains a stubborn clinical problem. Few treatments have been shown to be definitely effective for this problem. Polymethylmethacrylate (PMMA) microspheres in collagen (ArteFill, Suneva Medical Inc, Santa Barbara, CA) have shown long-term benefit for nasolabial fold treatment. A pilot study has shown benefit for PMMA-collagen in atrophic acne scarring. OBJECTIVE: We sought to demonstrate the safety and effectiveness of PMMA-collagen for acne scarring in a controlled, blinded trial. METHODS: Subjects with at least 4 moderate to severe rolling, atrophic scars randomly received PMMA-collagen or saline injections. Subjects underwent up to 2 injection sessions and were followed up for 6 months. Efficacy was assessed using a validated rating scale for each scar. RESULTS: In all, 147 subjects underwent injections. Success was achieved by 64% of those treated with PMMA-collagen compared with 33% of control subjects (P = .0005). The treatment showed excellent safety with generally mild, reversible adverse events. No significant differences in efficacy or safety were noted between genders, for darker skin types, or in older age groups. LIMITATIONS: Subjects were followed up for only 6 months. CONCLUSION:PMMA-collagen demonstrates substantial effectiveness in the treatment of atrophic acne scars of the face while maintaining an excellent safety profile. Further follow-up should be undertaken to demonstrate longer-term benefit and safety.