Christopher I Zoumalan1, Shiva C Tadayon2, Jason Roostaeian3, Anthony M Rossi4, Allen Gabriel5. 1. Keck School of Medicine, University of Southern California, Los Angeles, CA. 2. Private oculoplastic surgery practice in Los Angeles, CA. 3. Department of Plastic Surgery, UCLA David Geffen School of Medicine, Los Angeles, CA. 4. Dermatology Service, Memorial Sloan Kettering Center, New York, NY. 5. Department of Plastic Surgery, Loma Linda University Medical Center, Loma Linda, CA.
Abstract
BACKGROUND: Several growth factors and hyaluronic acid are implicated in fetal scarless healing. Whether these factors can be applied to an adult scar to improve scar characteristics is unknown. OBJECTIVES: This study compared the efficacy and safety of SKN2017B, a proprietary topical cream consisting of selective synthetic recombinant human growth factors and hyaluronic acid in a silicone base containing a specifically formulated silicone cream for postsurgical scar treatment. METHODS: In this prospective, randomized, controlled, double-blinded study, unilateral or bilateral facial or truncal scars in adult surgical patients were randomly treated with SKN2017B or silicone cream. Study investigators, study patients, and 2 independent reviewers assessed improvement in scar characteristics after 4 and 12 weeks of treatment. RESULTS:Forty-nine bilateral and12 unilateral scars in 45 patients were treated with SKN2017B or silicone. At 12 weeks, investigators rated 74% of scars treated with SKN2017B as showing overall improvement vs 54% of silicone-treated scars, a 73% relative improvement with SKN2017B (P < 0.0001). Patients rated a moderate-to-significant improvement in 85% of SKN2017B-treated scars vs 51% of silicone-treated scars, a 67% relative improvement with SKN2017B (P < 0.001). Independent reviewers rated 87% of scars treated with SKN2017B to be better overall vs 1% of scars treated with silicone (P < 0.0001). There were no tolerability issues or adverse reactions with either cream. CONCLUSIONS:SKN2017B consists of highly selective growth factors within a silicone cream matrix and is well tolerated and effective for surgical scar management.
RCT Entities:
BACKGROUND: Several growth factors and hyaluronic acid are implicated in fetal scarless healing. Whether these factors can be applied to an adult scar to improve scar characteristics is unknown. OBJECTIVES: This study compared the efficacy and safety of SKN2017B, a proprietary topical cream consisting of selective synthetic recombinant human growth factors and hyaluronic acid in a silicone base containing a specifically formulated silicone cream for postsurgical scar treatment. METHODS: In this prospective, randomized, controlled, double-blinded study, unilateral or bilateral facial or truncal scars in adult surgical patients were randomly treated with SKN2017B or silicone cream. Study investigators, study patients, and 2 independent reviewers assessed improvement in scar characteristics after 4 and 12 weeks of treatment. RESULTS: Forty-nine bilateral and 12 unilateral scars in 45 patients were treated with SKN2017B or silicone. At 12 weeks, investigators rated 74% of scars treated with SKN2017B as showing overall improvement vs 54% of silicone-treated scars, a 73% relative improvement with SKN2017B (P < 0.0001). Patients rated a moderate-to-significant improvement in 85% of SKN2017B-treated scars vs 51% of silicone-treated scars, a 67% relative improvement with SKN2017B (P < 0.001). Independent reviewers rated 87% of scars treated with SKN2017B to be better overall vs 1% of scars treated with silicone (P < 0.0001). There were no tolerability issues or adverse reactions with either cream. CONCLUSIONS:SKN2017B consists of highly selective growth factors within a silicone cream matrix and is well tolerated and effective for surgical scar management.