Randomized-Controlled Trial Comparing Safety and Efficacy of Repairing Balm vs Topical Antimicrobial for Post-Procedural Wounds

Abstract

Background: Actinic keratoses (AK) are pre-cancerous, intraepidermal lesions that exist on a continuum with squamous cell carcinoma. Cryotherapy using liquid nitrogen freezing is the most common method for treating AKs. Following cryotherapy, wound care often involves antimicrobial ointments as prophylactics against infection. However, given the rise in antibacterial resistance and possible contact dermatitis, equivalent alternatives should be identified. Cutaneous wound healing is important in dermatologic conditions.

Objective: Evaluate the safety (adverse events) and efficacy (erythema and oozing/crusting, speed of recovery) of post-procedural wound healing of AK lesions, when using either a topical antibiotic (PSO), or a nonprescription repairing balm containing panthenol, madecassoside, and metal salts (CB5).

Methods: A multicenter, intra-individual, randomized control trial was conducted. Sixty participants with at least 3 AK lesions on each arm were enrolled. Following cryotherapy, 3 lesions were selected on each arm for study and control treatment. The treatment of the right or left arm was randomly assigned to either the control group (PSO) or the investigational group (CB5), so that each subject participated in both the investigational and control arms. At each visit, the physician assessed the skin condition (erythema, oozing/crusting) and adverse events, and subject satisfaction was recorded. Results: There were no clinically significant differences in time to lesion healing, erythema, or oozing/crusting between groups. On day 21, 100% of patients agreed that their lesions had improved. No adverse events related to the study products were reported throughout the trial. Conclusion: Post-procedural treatment with CB5 and PSO demonstrated equivalent wound healing in participants undergoing liquid nitrogen cryotherapy for AKs without the potential for further adverse effects.

Citation: Lynde CW, Andriessen A, Guenther L, et al. Randomized-controlled trial comparing safety and efficacy of repairing balm versus topical antimicrobial for post-procedural wounds. J Drugs Dermatol. 2025;24(5):507-515. doi:10.36849/JDD.8746R1.