Acne VulgarisNCT07805655
Radiofrequency Treatment Versus Topical Therapy for Facial Acne Vulgaris
A study testing Adapalene 0.1% and Benzoyl Peroxide 2.5% gel and Sequential Radiofrequency Treatment in people with Acne Vulgaris, run by Jeisys Medical Inc at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Adapalene 0.1% and Benzoyl Peroxide 2.5% gel and Sequential Radiofrequency Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- 15 Sep 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Especialistas de la Piel y Cirugía, S.C.
Nuevo León, Monterrey, 64060
Hector Leal Dr., +528119655342, hleal@iderma.org
About this study
Official title: A Prospective, Pragmatic, Open-Label Clinical Trial of Sequential Radiofrequency Treatment Compared With Standard Topical Therapy for Mild-to-Moderate Inflammatory Facial Acne Vulgaris
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.
Read the 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.
- Conditions
- Acne Vulgaris
- Being tested
- Adapalene 0.1% and Benzoyl Peroxide 2.5% gel, Sequential Radiofrequency Treatment
- Keywords
- Facial Acne, Radiofrequency Treatment, Density Noir, Sebum Production, Mild-to-Moderate Acne
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapalene 0.1% and Benzoyl Peroxide 2.5% gelDrug
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 TreatmentDevice
Also called Density Noir System
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.
| Study group | Role | What they receive |
|---|---|---|
| Sequential Radiofrequency Treatment | Experimental | Participants will receive three sequential radiofrequency treatment sessions using the Density Noir System at 6-week intervals. Receives: 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. Receives: Drug: Adapalene 0.1% and Benzoyl Peroxide 2.5% gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 12
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately after each treatment and at protocol-specified post-treatment assessments through Week 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion25 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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%.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeisys Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805655
- Sponsor's protocol ID
- DEN-30-2026
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Pragmatic, Open-Label Clinical Trial of Sequential Radiofrequency Treatment Compared With Standard Topical Therapy for Mild-to-Moderate Inflammatory Facial Acne Vulgaris
- ClinicalTrials.gov ID
- NCT07805655
- Acronym / sponsor ID
- DEN-30-2026
- Conditions
- Acne Vulgaris
- Keywords
- Facial Acne, Radiofrequency Treatment, Density Noir, Sebum Production, Mild-to-Moderate Acne
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jeisys Medical IncIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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%.
| Arm | Type | Receives |
|---|---|---|
| Sequential Radiofrequency Treatment | Experimental | Device: Sequential Radiofrequency TreatmentParticipants will receive three sequential radiofrequency treatment sessions using the Density Noir System at 6-week intervals. |
| Adapalene 0.1% and Benzoyl Peroxide 2.5% | Active comparator | Drug: Adapalene 0.1% and Benzoyl Peroxide 2.5% gelParticipants will apply adapalene 0.1%/benzoyl peroxide 2.5% fixed-combination gel once daily to the entire face for 12 weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapalene 0.1% and Benzoyl Peroxide 2.5% gelParticipants 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. | Drug | Adapalene 0.1% and Benzoyl Peroxide 2.5% |
| Sequential Radiofrequency TreatmentAlso: Density Noir SystemParticipants 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. | Device | Sequential Radiofrequency Treatment |
Primary outcome
Change From Baseline in Inflammatory Lesion Count
Time frame: 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.
7 secondary outcomes
Percentage of Participants Achieving Investigator Global Aesthetic improvement scale (IGAIS) Responder Status at Week 24
Time frame: Baseline to Week 24
Change From Baseline in Erythema Index at week 24.
Time frame: Baseline to Week 24
Change From Baseline in Dermatology Life Quality Index (DLQI) at week 24
Time frame: Baseline to week 24
Participant Global Satisfaction With Treatment at week 24
Time frame: at Week 24
Number of Participants With Treatment-Emergent Adverse Events
Time frame: Immediately after each treatment and at protocol-specified post-treatment assessments through Week 24.
Pain Score Following Radiofrequency Treatment
Time frame: Immediately after each treatment.
Number of Participants With Acute Local Skin Responses Following Radiofrequency Treatment
Time frame: Immediately after each treatment and at protocol-specified post-treatment assessments through Week 24.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapalene 0.1% and Benzoyl Peroxide 2.5% gel and Sequential Radiofrequency Treatment in people with Acne Vulgaris, run by Jeisys Medical Inc at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shaheen Amna Kashif, PhD (+82-10-5798-6117, shaheen@jeisys.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Inflammatory Lesion Count (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.