Health TrialsbyHealthPanel

Radiofrequency Treatment Versus Topical Therapy for Facial Acne Vulgaris

ConditionAcne Vulgaris
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorJeisys Medical Inc

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Sequential Radiofrequency TreatmentExperimental treatment 1 intervention
Group B: Adapalene 0.1% and Benzoyl Peroxide 2.5%Active comparator 1 intervention

Trial outcomes

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.

Time frame
Baseline to Week 12

Secondary outcomes

1

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

Proportion of participants achieving an IGAIS score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline.

Time frame
Baseline to Week 24
2

Change From Baseline in Erythema Index at week 24.

Change in erythema index at a standardized inflammatory lesion site will be measured using a colorimeter.

Time frame
Baseline to Week 24
3

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

Change in total Dermatology Life Quality Index score will be assessed to evaluate the impact of treatment on participants' dermatology-related quality of life.

Time frame
Baseline to week 24
4

Participant Global Satisfaction With Treatment at week 24

Participant satisfaction (using participant GAIS) with the treatment outcome will be assessed using the standardized study question at the final follow-up visit.

Time frame
at Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jeisys Medical Inc

Lead sponsor

Source ClinicalTrials.gov
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