RECRUITING Not applicable ClinicalTrials.gov

Radiofrequency Treatment Versus Topical Therapy for Facial Acne Vulgaris

Sponsor: Jeisys Medical Inc • ClinicalTrials.gov ID: NCT07805655

Registry updated: 2026-09-04

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

This clinical study will compare a radiofrequency (RF) treatment with a standard topical treatment for adults with mild-to-moderate inflammatory facial acne vulgaris. Approximately 60 participants will be randomly assigned to one of two treatment groups. Participants in the RF group will receive three treatment sessions using the Density Noir radiofrequency system at 6-week intervals. Participants in the topical treatment group will use a combination gel containing adapalene 0.1% and benzoyl peroxide 2.5% once daily for 12 weeks. Participants in both groups will be followed for an additional 12 weeks after completion of treatment. The main purpose of the study is to compare how well the two treatments reduce the number of inflammatory acne lesions and facial sebum production. The study will also evaluate treatment safety and tolerability. Additional assessments will include overall acne severity, skin redness, dermal thickness, quality of life, treatment-related pain, participant satisfaction, and durability of treatment response.

Interventions

Adapalene 0.1% and Benzoyl Peroxide 2.5% gel (Drug)
Participants will apply a fixed-combination topical gel containing adapalene 0.1% and benzoyl peroxide 2.5% once daily to the entire face for 12 weeks.
Sequential Radiofrequency Treatment (Device)
Participants will receive three radiofrequency treatment sessions using the Density Noir System (6.78 MHz) at 6-week intervals. Treatment consists of two sequential phases: global facial treatment using the Classic F Tip in MONO+BI mode, followed by targeted treatment of individual inflammatory acne lesions using the Classic E Tip in bipolar mode.

Eligibility criteria

Inclusion Criteria: * Male or female participants aged 18-40 years. * Clinical diagnosis of mild-to-moderate inflammatory facial acne vulgaris, defined as Investigator Global Assessment (IGA) Grade 2 or 3. * Presence of 10-40 inflammatory facial lesions (papules and pustules). * Willing and able to comply with the study requirements, treatment schedule, and follow-up visits. * Able to understand the study procedures and provide written informed consent. Exclusion Criteria: * Severe acne, including nodulocystic acne. * Active skin infection, open wound, or other significant dermatologic condition in the treatment area that may interfere with study assessments or treatment. * Use of systemic isotretinoin within the protocol-specified period before enrollment. * Recent use of systemic or topical acne treatments that may interfere with evaluation of the study interventions. * Previous energy-based device treatment to the facial area within the protocol-specified period before enrollment. * Pregnancy or breastfeeding. * Presence of an implanted electronic device or other contraindication to radiofrequency treatment. * Known hypersensitivity or contraindication to adapalene, benzoyl peroxide, or other components of the comparator treatment. * Any medical condition or medication use that, in the investigator's judgment, may affect participant safety, study participation, or interpretation of study results.

Conditions

Acne Vulgaris

Locations

Especialistas de la Piel y Cirugía, S.C. — Nuevo León, Monterrey, Mexico

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment