Radiofrequency Treatment Versus Topical Therapy for Facial Acne Vulgaris

Acne vulgaris is a common inflammatory skin condition involving the pilosebaceous unit. Increased sebum production, abnormal follicular keratinization, proliferation of Cutibacterium acnes, and inflammation contribute to its development. Standard treatments for mild-to-moderate acne include topical medications such as retinoids and benzoyl peroxide. Radiofrequency has also been investigated as a non-pharmacological approach to acne treatment, with previous studies suggesting potential effects on sebum production, inflammatory lesions, and dermal structure. This is a prospective, randomized, parallel-group, open-label clinical trial designed to compare a sequential RF treatment protocol with standard topical therapy in adults with mild-to-moderate inflammatory facial acne vulgaris. Approximately 60 eligible participants will be randomized in a 1:1 ratio to an RF treatment group or an active topical comparator group. Participants assigned to the RF group will receive three treatment sessions at 6-week intervals using the Density Noir System (6.78 MHz). Treatment consists of two sequential phases. The first phase uses the Classic F Tip in MONO+BI mode to provide global facial treatment. The second phase uses the Classic E Tip in bipolar mode to provide targeted treatment of individual inflammatory acne lesions. Participants assigned to the topical comparator group will use a fixed-combination gel containing adapalene 0.1% and benzoyl peroxide 2.5%, applied once daily to the entire face for 12 weeks. The primary efficacy assessments are the change from baseline in inflammatory lesion count and facial sebum production. Safety and tolerability will be assessed by evaluating acute local skin responses after RF treatment and by monitoring adverse events throughout the study. Secondary assessments include Investigator Global Assessment (IGA), erythema index, dermal thickness measured by high-frequency ultrasound, Dermatology Life Quality Index (DLQI), procedural pain, durability of treatment response, and participant satisfaction. Participants will be followed for approximately 24 weeks, including the treatment period and post-treatment follow-up.