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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Mexico
Especialistas de la Piel y Cirugía, S.C.
RECRUITING
Nuevo León
Contact Information
Primary
Shaheen Amna Kashif, PhD
shaheen@jeisys.com
+82-10-5798-6117
Time Frame
Start Date: 2026-09-15
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 60
Treatments
Experimental: Sequential Radiofrequency Treatment
Participants will receive three sequential radiofrequency treatment sessions using the Density Noir System at 6-week intervals.
Active_comparator: Adapalene 0.1% and Benzoyl Peroxide 2.5%
Participants will apply adapalene 0.1%/benzoyl peroxide 2.5% fixed-combination gel once daily to the entire face for 12 weeks.
Related Therapeutic Areas
Sponsors
Leads: Jeisys Medical Inc

This content was sourced from clinicaltrials.gov