Scars are the result of skin healing process after incisions, burns, acne and other wounds resulting from sports or trauma. Scars have physical, cosmetic and emotional implications. We present a prospective, randomized, open clinical study, assessing the efficacy and safety of REGEN-SIL® siliconic gel, in therapeutic management of post-operative hypertrophic and keloid scars compared to the ... [Show full abstract] efficacy and safety of another silicone gel available on pharmaceutical market, both products being authorized as medical devices with the same therapeutic indications. One hundred patients undergoing incisions in the anterolateral cervical region for thyroid and parathyroid glands surgical approach were randomly assigned into two groups: REGEN-SIL® group (50 patients) and Silicone Gel group (50 patients). The application of silicone-based products started immediately after the sutures were removed. The scars evolution was assessed through Vancouver Scar Scale (VSS) at baseline, at one month and three months of treatment onset. Side effects that could occur following administration of both products have been monitored. In addition, patient and physician satisfaction were evaluated. Ninety-three patients completed the trial and all assessments of scars revealed significantly better improvement scaring process in REGEN-SIL® group than in Silicone Gel group after 3 months of treatment onset. No side effects were recorded in both groups. This study has demonstrated the superior efficacy of REGEN-SIL® in therapeutic management of post-operative hypertrophic and keloid scars, and also a greater appreciation from the side of patients and physicians versus the comparative product. © 2017, Romanian Society for Pharmaceutical Sciences. All rights reserved.