A double-blind, randomized, multicenter, controlled trial of suspended polymethylmethacrylate microspheres for the correction of atrophic facial acne scars - 18/06/14

Doi : 10.1016/j.jaad.2014.02.034

Jwala Karnik, MD ^a, Leslie Baumann, MD ^l, Suzanne Bruce, MD ^b, Valerie Callender, MD ^c,^d, Steven Cohen, MD ^e,^f, Pearl Grimes, MD ^m, John Joseph, MD ^h, Ava Shamban, MD ⁱ, James Spencer, MD ^j, Ruth Tedaldi, MD ⁿ, William Philip Werschler, MD ^k, Stacy R. Smith, MD ^g,^⁎
^a Suneva Medical Inc, Santa Barbara, California
^b Suzanne Bruce and Associates, Houston, Texas
^c Callender Dermatology and Cosmetic Center, Glenn Dale, Maryland
^d Howard University College of Medicine, Washington, District of Columbia
^e FACES+ Plastic Surgery, Skin, and Laser Center, San Diego, California
^f Division of Plastic Surgery, University of California, San Diego, California
^g Division of Dermatology, University of California, San Diego, California
^h Clinical Testing Center of Beverly Hills, CA, University of California, Los Angeles, Geffen School of Medicine, Los Angeles, California
ⁱ University of California, Los Angeles, Geffen School of Medicine, Los Angeles, California
^j Mount Sinai School of Medicine, New York, New York
^k Division of Dermatology University of Washington School of Medicine, Seattle, Washington
^l Baumann Cosmetic and Research Institute, Miami, Florida
^m Vitiligo & Pigmentation Institute of Southern California, University of California, Los Angeles Geffen School of Medicine, Los Angeles, California
ⁿ private practice, Wellesley, Massachusetts

^∗Reprint requests: Stacy R. Smith, MD, 561 Saxony Place, Suite 102, Encinitas, CA 92024.

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 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.

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Key words : acne, acne scars, collagen, dermal filler, microspheres, polymethylmethacrylate

Abbreviations used : AE, ASRS, FDA, PMMA

Plan

	Supported by Suneva Medical Inc.
	Conflicts of interest: None declared.

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Vol 71 - N° 1

P. 77-83 - juillet 2014 Retour au numéro

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A double-blind, randomized, multicenter, controlled trial of suspended polymethylmethacrylate microspheres for the correction of atrophic facial acne scars - 18/06/14

Abstract

Background

Objective

Methods

Results

Limitations

Conclusion

Plan

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