Randomized-Controlled Trial Comparing Safety and Efficacy of Repairing Balm vs Topical Antimicrobial for Post-Procedural Wounds
May 2025 | Volume 24 | Issue 5 | 507 | Copyright © May 2025
Published online April 30, 2025
Charles W. Lynde MD FRCPCa, Anneke Andriessen PhDb, Lyn Guenther MD FRCPCc, Nour Dayeh d, Sandra Skotnicki MD FRCPCe, Simon Nigen MD BPharm FRCPCf, Gary R. Sibbald MD FRCPC MACP FAAD MEd FAPWCAg
aDepartment of Medicine, University of Toronto, Toronto, ON; Lynderm Research, Markham, ON, Canada
bRadboud University Medical Center, Nijmegen, The Netherlands; RBC Consultants, Malden, The Netherlands
cDermatology, Western University, London, ON; Guenther Research Inc London, ON, Canada
dEmployee of L’Oréal, Montreal QC, Canada
eDepartment of Medicine, Divisions of Dermatology and Occupational and Environmental Health, University of Toronto, Toronto, ON, Canada; Bay Dermatology Centre, Toronto, ON, Canada
fDivision of Dermatology, Department of Medicine, McGill University, Montreal, QC, Canada; Sima Recherche, Université de Montréal, Montreal, QC, Canada
gProject ECHO Ontario Skin and Wound. Medicine and Public Health, University of Toronto, Toronto, ON, Canada
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
INTRODUCTION
Actinic Keratosis And Cryotherapy
Actinic keratosis (AK) is a concern worldwide and is associated with an increased risk of development of non-melanoma skin cancer.1 Chronic sun exposure plays a central role in its pathogenesis.2 AKs are among the most common skin lesions, accounting for a significant proportion of primary diagnoses made in dermatological practice. Relatedly, the treatment of AKs is the most common procedure performed in dermatology.3 The prevalence of AKs has been estimated to be between 40 to 60% of the fair-skinned population aged > 40 years, with the average patient having six to eight lesions.4 Clinically, AKs present as red, scaly macules and papules (Figure 1). In some cases, they
