Acne Vulgaris
Conditions
Keywords
Facial Acne, Radiofrequency Treatment, Density Noir, Sebum Production, Mild-to-Moderate Acne
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.
Detailed description
Acne vulgaris is a common inflammatory skin condition involving the pilosebaceous unit. Increased sebum production, abnormal follicular keratinization, proliferation of Cutibacterium acnes, and inflammation contribute to its development. Standard treatments for mild-to-moderate acne include topical medications such as retinoids and benzoyl peroxide. Radiofrequency has also been investigated as a non-pharmacological approach to acne treatment, with previous studies suggesting potential effects on sebum production, inflammatory lesions, and dermal structure. This is a prospective, randomized, parallel-group, open-label clinical trial designed to compare a sequential RF treatment protocol with standard topical therapy in adults with mild-to-moderate inflammatory facial acne vulgaris. Approximately 60 eligible participants will be randomized in a 1:1 ratio to an RF treatment group or an active topical comparator group. Participants assigned to the RF group will receive three treatment sessions at 6-week intervals using the Density Noir System (6.78 MHz). Treatment consists of two sequential phases. The first phase uses the Classic F Tip in MONO+BI mode to provide global facial treatment. The second phase uses the Classic E Tip in bipolar mode to provide targeted treatment of individual inflammatory acne lesions. Participants assigned to the topical comparator group will use a fixed-combination gel containing adapalene 0.1% and benzoyl peroxide 2.5%, applied once daily to the entire face for 12 weeks. The primary efficacy assessments are the change from baseline in inflammatory lesion count and facial sebum production. Safety and tolerability will be assessed by evaluating acute local skin responses after RF treatment and by monitoring adverse events throughout the study. Secondary assessments include Investigator Global Assessment (IGA), erythema index, dermal thickness measured by high-frequency ultrasound, Dermatology Life Quality Index (DLQI), procedural pain, durability of treatment response, and participant satisfaction. Participants will be followed for approximately 24 weeks, including the treatment period and post-treatment follow-up.
Interventions
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.
DEVICESequential 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.
Sponsors
Jeisys Medical Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
none (open label)
Intervention model description
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%.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Inflammatory Lesion Count | Baseline to Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Investigator Global Aesthetic improvement scale (IGAIS) Responder Status at Week 24 | Baseline to 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. |
| Change From Baseline in Erythema Index at week 24. | Baseline to Week 24 | Change in erythema index at a standardized inflammatory lesion site will be measured using a colorimeter. |
| Change From Baseline in Dermatology Life Quality Index (DLQI) at week 24 | Baseline to 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. |
| Participant Global Satisfaction With Treatment at week 24 | 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. |
| Number of Participants With Treatment-Emergent Adverse Events | Immediately after each treatment and at protocol-specified post-treatment assessments through Week 24. | The number of participants experiencing treatment-emergent adverse events will be assessed. Adverse events will be evaluated for severity and relationship to the study treatment in accordance with the study protocol. |
| Pain Score Following Radiofrequency Treatment | Immediately after each treatment. | Procedural pain associated with radiofrequency treatment will be assessed using the \[11-point Numeric Rating Scale (NRS)\]. Scores range from \[0, minimum\] to \[10, maximum\], with higher scores indicating greater pain. |
| Number of Participants With Acute Local Skin Responses Following Radiofrequency Treatment | Immediately after each treatment and at protocol-specified post-treatment assessments through Week 24. | The number of participants experiencing acute local skin responses following radiofrequency treatment will be assessed. Local skin responses will include erythema, edema, dryness, scaling, crusting, and other treatment-site reactions specified in the study protocol. The presence and severity of each local skin response will be assessed at the protocol-specified post-treatment assessments. |
Countries
Mexico
Contacts
CONTACTShaheen Amna Kashif, PhD
Outcome results
None listed