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Recruiting
NCT07805655
Radiofrequency Treatment Versus Topical Therapy for Facial Acne Vulgaris
Conditions: Acne Vulgaris
Sex: All
Ages: 18 Years – 40 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Jeisys Medical Inc
Location: Especialistas de la Piel y Cirugía, S.C. Nuevo León Monterrey
Summary
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.
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.
Source: ClinicalTrials.gov (NCT07805655). StuddyBuddy aggregates publicly available trial information.