A double-blind, controlled pilot study of a silicone gel with superoxidized water versus an 8% pirfenidone gel for the treatment of hypertrophic scars and keloids

Background: Hypertrophic scars (HS) and keloids (KS) are common, and treatment success is variable. Topical pirfenidone is widely used in Mexico, although no comparative studies on its efficacy are available. Silicone is considered the standard treatment. Objective: To compare the efficacy of a silicone gel with superoxidized water versus an 8% pirfenidone gel for the treatment of KS and HS. Materials and methods: Pilot, comparative, experimental, prospective, longitudinal, non-inferiority study with a blinded evaluator. Two groups of 20 patients were randomly assigned to receive identical tubes of either silicone gel with superoxidized water or pirfenidone gel. Follow-up was scheduled at 2, 4, 8, 12, and 16 weeks, recording scar location, cause, evolution time, symptoms, skin phototype, Dermatology Life Quality Index (DLQI), and scar assessment scales (POSAS, VSS, AVS). Results: Forty patients were randomized to receive treatment with either silicone or pirfenidone. Ten patients did not complete the study (6 from the silicone group and 4 from the pirfenidone group). Baseline characteristics were comparable between groups. After 16 weeks of follow-up, both treatments showed comparable improvements in symptoms (pruritus 85%, dysesthesia 75%, pain 50%) and scar appearance, with no significant differences in clinical scales or DLQI. There was a single case of contact dermatitis (pirfenidone). Conclusions: Both the topical silicone gel and the pirfenidone gel are equally effective in the treatment of keloids and hypertrophic scars.