Randomized-Controlled Trial Comparing Safety and Efficacy of Repairing Balm vs Topical Antimicrobial for...

Area of Science:

• Dermatology
• Wound Healing
• Oncology

Background:

• Actinic keratoses (AKs) are pre-cancerous lesions on a continuum with squamous cell carcinoma.
• Cryotherapy is a common AK treatment, often followed by antimicrobial ointments for wound care.
• Concerns regarding antibiotic resistance and contact dermatitis necessitate exploring alternative post-procedural treatments.

Purpose of the Study:

• To evaluate the safety and efficacy of a novel repairing balm (CB5) compared to a topical antibiotic (PSO) for wound healing after actinic keratosis cryotherapy.
• To assess adverse events, erythema, oozing/crusting, and speed of recovery in post-procedural AK lesions.

Main Methods:

• A multicenter, intra-individual, randomized controlled trial was conducted with 60 participants.
• Participants received cryotherapy for AK lesions on both arms.
• Three lesions per arm were treated with either the repairing balm (CB5) or topical antibiotic (PSO) in a randomized manner.

Main Results:

• No significant differences were observed in healing time, erythema, or oozing/crusting between the CB5 and PSO groups.
• 100% of patients reported lesion improvement by day 21.
• No adverse events related to either study product were reported.

Conclusions:

• The repairing balm (CB5) demonstrated equivalent safety and efficacy to topical antibiotics (PSO) for post-procedural wound healing of actinic keratosis lesions.
• CB5 offers a viable alternative to topical antibiotics, mitigating risks associated with antibiotic resistance and contact dermatitis.
• Both treatments supported successful cutaneous wound healing following cryotherapy.