RF treatment vs topical therapy for facial acne vulgaris

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, randomized study compares a sequential radiofrequency treatment using Density Noir with a fixed-combination adapalene 0.1% and benzoyl peroxide 2.5% gel in adults with mild-to-moderate inflammatory facial acne. Participants are randomly assigned to RF (three sessions at six-week intervals) or topical therapy (daily gel for 12 weeks), with follow-up continuing for 12 weeks after treatment. The primary outcomes are changes in inflammatory lesion counts and facial sebum production, while safety, tolerability, acne severity, skin redness, dermal thickness, quality of life, and treatment-related pain are also evaluated. The study is open-label and aims to determine which approach offers better symptom control and tolerability in a real-world setting. Approximately 60 participants will be enrolled, with equal allocation to each group.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Shaheen Amna Kashif, PhD
• Email: shaheen@jeisys.com
• Phone: +82-10-5798-6117

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.