Observer-Blinded, Randomized Study to Determine the Safety and Efficacy of a Silicone Gel (RecedoTM Gel) Versus a Gel Containing Onion Extract (Mederma® Advanced Scar Gel) for the Appearance and Symptoms of Surgical Scars Brian Berman, MD, PhD, and Mark Nestor, MD, PhD Center for Clinical and Cosmetic Research, Aventura, FL Background • Scarring can cause functional, cosmetic, and psychological morbidity1 • The clinical symptoms of scars include tenderness, discoloration, pruritus, and disfigurement • Remedial treatments used for scars include surgery, laser therapy, steroid injections, and topical products such as onion extract gel and silicone gel2 • The use of silicone gel sheets for treating burns has revealed that skin grafts refrain from shrinking, while the area around the burns heals by epithelialization without hypertrophy3 • Silicone gels and sheets are widely considered as first-line treatment for scars2 Objectives • To evaluate the safety and efficacy, in terms of appearance and symptoms, of a 100% silicone gel (RecedoTM) compared with an onion extract-containing gel (Mederma®) in adult subjects with postsurgical scars Methods Study Design • Randomized, evaluator-blinded, single-center, 16-week, active- comparator clinical study (Figure 1) • All subjects had postsurgical scars that were 2 weeks to 4 months old • The initial treatment was applied to the affected scar at the baseline visit (day 0) by a designated device dispenser at that site who was not responsible for any subject or scar evaluations • All remaining treatments were applied by the subject • Study visits were scheduled for baseline (day 0, first investigational product application), week 2, week 8, week 12 (end of treatment), and a final evaluation at week 16 (follow-up or early termination) Figure 1. Study Design Figure 1. Study Design 1:1 Randomization Day 0 Baseline Week 2 Week 12 End of treatment 100% silicone gel Twice daily (BID), n=24 Onion extract-containing gel Once daily (OD), n=24 Week 16 Follow-up assessment Follow-up Week 8 Study Visits Efficacy Assessments • Vancouver Scar Scale (VSS) total score Change from baseline to week 16 (including ratings of vascularity, pliability, and height, with scores of 0-3 for each; total potential score range was 0-9) • Pain and itch scores Change from baseline to week 16 (including ordinal ratings of 0-3 for each, and visual analog scale [VAS] scores of 0-10 cm for each) • Investigator’s and Subject’s Global Assessment of Scar Treatment Assessed at weeks 8, 12, and 16 (4-point assessments: 1=very good, 2=good, 3=moderate, and 4=unsatisfactory) • Comparison between the 2 study groups in the Subject’s Global Assessment of Scar Treatment at weeks 8, 12, and 16 Safety Assessments • Adverse events (AEs) and serious AEs Results Baseline Characteristics • Subjects were well matched, with no significant differences between study groups for age, gender, ethnicity, race, or age of scar (Table 1) • 1 subject in the onion extract-containing gel OD group was lost to follow-up after the baseline visit Table 1. Baseline Characteristics 100% silicone gel BID (n=24) Onion extract- containing gel OD (n=24) Gender, n (%) Male Female 13 (54.2) 11 (45.8) 10 (41.7) 14 (58.3) Age, mean, years 61.7 60.5 Ethnicity, n (%) Hispanic or Latino Non-Hispanic or -Latino 6 (25) 18 (75) 5 (20.8) 19 (79.2) Race, n (%) White Hispanic Black/African American 20 (83.3) 4 (16.7) 0 (0) 20 (83.3) 3 (12.5) 1 (4.2) Age of scar, mean, days 45 52.4 Efficacy Evaluations VSS Score • The mean VSS score increasingly improved (decreased) from baseline for both groups during the course of the study (Figure 2) • The improvement was significantly greater for the 100% silicone gel BID group at week 2 (P<.01) and at the end of the study at week 16 (P<.05) compared with the onion extract-containing gel OD group Figure 2. Improvement in Mean VSS Score From Baseline Figure 2. Improvement in Mean VSS Score From Baseline 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 Week 2 Week 8 Week 12 Week 16 M e a n C h a n g e F ro m B a s e li n e P<.05 P<.01 100% silicone gel BID Onion extract-containing gel OD Pain and Itch Assessments • There was a significant reduction in subject-reported itch from baseline in the 100% silicone gel BID group but not in the onion extract-containing gel OD group • Mean VAS scores – 100% silicone gel BID 0.3 at baseline 0 at week 16 (P<.02) – Onion extract-containing gel OD 0.2 at baseline 0.09 at week 16 • There were no significant differences between groups in subject- reported itch • There were no significant differences from baseline or between groups in subject-reported pain Investigator’s Global Assessment of Scar Treatment • The mean change from baseline for the Investigator’s Global Assessment of Scar Treatment increased significantly from week 2 to week 16 in both groups (P<.001 for each) (Figure 3) Figure 3. Mean Change From Baseline in Investigator’s Global Assessment of Scar Treatment Figure 3. Investigator’s Global Assessment of Scar Treatment 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 P<.001 M e a n C h a n g e F ro m B a s e li n e Week 2 Week 16 Week 2 Week 16 100% silicone gel BID Onion extract- containing gel OD P<.001 Subject’s Global Assessment of Scar Treatment • Similar to the Investigator’s Global Assessment, the mean change from baseline in the Subject’s Global Assessment of Scar Treatment increased significantly from week 2 to week 16 in both groups (P<.04 for 100% silicone gel BID and P<.03 for onion extract-containing gel OD) (Figure 4) Figure 4. Mean Change From Baseline in Subject’s Global Assessment of Scar Treatment Figure 4. Subject’s Global Assessment of Scar Treatment 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 P<.04 Week 2 Week 16 Week 2 Week 16 P<.03 M e a n C h a n g e F ro m B a s e li n e 100% silicone gel BID Onion extract- containing gel OD Safety Evaluation • 10 subjects experienced AEs during the study • The most common treatment-related AE was mild-to-moderate itching at the site of application, which was reported by 5 subjects (21.7%) in the onion extract-containing gel OD group and 0 subjects in the 100% silicone gel BID group (P<.02) • Application-site tenderness (recorded as burning, tingling, or sensitivity) occurred in 2 subjects (6.3%) • No serious AEs occurred during the study Conclusions • Both the 100% silicone gel and the onion extract-containing gel were effective and safe in improving the appearance of postsurgical scars • As assessed by the VSS, the 100% silicone gel BID was significantly more effective than the onion extract-containing gel OD at improving postsurgical scars • The 100% silicone gel BID was better tolerated than was the onion extract-containing gel OD, as nearly one-quarter of onion extract-containing gel OD subjects had mild-to- moderate itching at the application site, versus no subjects receiving 100% silicone gel BID References 1. Bock O, et al. Arch Dermatol Res. 2006;297(10):433-438. 2. Monstrey S, et al. J Plast Reconstr Aesthet Surg. 2014;67(8):1017-1025. 3. Perkins K, et al. Burns Incl Therm Inj. 1983;9(3):201-204.Disclosure: This study was funded by Exeltis USA Dermatology, LLC. FC17PosterExeltisBermanObserverBlindedStudyGel.pdf