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RECRUITING
NCT07805655
NA

Radiofrequency Treatment Versus Topical Therapy for Facial Acne Vulgaris

Sponsor: Jeisys Medical Inc

View on ClinicalTrials.gov

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.

Official title: A Prospective, Pragmatic, Open-Label Clinical Trial of Sequential Radiofrequency Treatment Compared With Standard Topical Therapy for Mild-to-Moderate Inflammatory Facial Acne Vulgaris

Key Details

Gender

All

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-09-15

Completion Date

2026-12-31

Last Updated

2026-09-04

Healthy Volunteers

No

Conditions

Interventions

DRUG

Adapalene 0.1% and Benzoyl Peroxide 2.5% gel

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.

DEVICE

Sequential Radiofrequency Treatment

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.

Locations (1)

Especialistas de la Piel y Cirugía, S.C.

Nuevo León, Monterrey, Mexico