Radiofrequency Treatment Versus Topical Therapy for Facial Acne Vulgaris

NCT07805655 | Recruiting

• 1 other identifier: DEN-30-2026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acne Vulgaris

Keywords

Facial Acne; Radiofrequency Treatment; Density Noir; Sebum Production; Mild-to-Moderate Acne

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Inflammatory Lesion Count

  Change in the number of facial inflammatory acne lesions from baseline to 12 weeks after completion of treatment will be assessed for each treatment group.

  Baseline to Week 12

Secondary Outcomes (7)

• Percentage of Participants Achieving Investigator Global Aesthetic improvement scale (IGAIS) Responder Status at Week 24

  Baseline to Week 24

• Change From Baseline in Erythema Index at week 24.

  Baseline to Week 24

• Change From Baseline in Dermatology Life Quality Index (DLQI) at week 24

  Baseline to week 24

• Participant Global Satisfaction With Treatment at week 24

  at Week 24

• Number of Participants With Treatment-Emergent Adverse Events

  Immediately after each treatment and at protocol-specified post-treatment assessments through Week 24.

Study Arms (2)

Sequential Radiofrequency Treatment

EXPERIMENTAL

Participants will receive three sequential radiofrequency treatment sessions using the Density Noir System at 6-week intervals.

Device: Sequential Radiofrequency Treatment

Adapalene 0.1% and Benzoyl Peroxide 2.5%

ACTIVE COMPARATOR

Participants will apply adapalene 0.1%/benzoyl peroxide 2.5% fixed-combination gel once daily to the entire face for 12 weeks.

Drug: Adapalene 0.1% and Benzoyl Peroxide 2.5% gel

Interventions

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.

Also known as: Density Noir System

Sequential Radiofrequency Treatment

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.

Adapalene 0.1% and Benzoyl Peroxide 2.5%

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jeisys Medical Inc: lead

Study Sites (1)

Especialistas de la Piel y Cirugía, S.C.

Nuevo León, Monterrey, 64060, Mexico

RECRUITING

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Adapalene; Benzoyl Peroxide; Gels

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Shaheen Amna Kashif, PhD

CONTACT

+82-10-5798-6117; shaheen@jeisys.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: none (open label)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1 ratio to one of two parallel treatment groups: sequential radiofrequency treatment or standard topical therapy with adapalene 0.1%/benzoyl peroxide 2.5%.

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 4, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 4, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)