An interventional study of Adapalene 0.1% and Benzoyl Peroxide 2.5% gel and Sequential Radiofrequency Treatment in Acne Vulgaris, sponsored by Jeisys Medical Inc. Recruiting at 1 site in Mexico. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Jeisys Medical Inc · Not applicable, Interventional, and Treatment
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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.
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.
791 studies on the registry are indexed under Acne Vulgaris; 94 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 673 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Jeisys Medical Inc is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive three sequential radiofrequency treatment sessions using the Density Noir System at 6-week intervals.
Device: Sequential Radiofrequency Treatment
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
Drug page: Adapalene
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.
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
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
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
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
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
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
Number of Participants With Treatment-Emergent Adverse Events
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.
Time frame: Immediately after each treatment and at protocol-specified post-treatment assessments through Week 24.
Pain Score Following Radiofrequency 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.
Time frame: Immediately after each treatment.
Number of Participants With Acute Local Skin Responses Following Radiofrequency Treatment
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.
Time frame: Immediately after each treatment and at protocol-specified post-treatment assessments through Week 24.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Dec 2026, 3 months later.
Of 62 industry-sponsored interventional studies with no phase under Acne Vulgaris, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 19. This study's planned 3 months is below that.
Counting every sponsor, half of 120 studies reached it within 9 months; a quarter within 4 and three quarters within 18.
How these figures are worked out, and which studies are left out of them.
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