Acne VulgarisPhase 4NCT07244887
Randomized, Triple-Blind, Vehicle-Controlled Trial of Topical Dapsone Gel 7.5% in Patients With Acne Vulgaris
A Phase 4 study testing Dapsone 7.5% gel in people with Acne Vulgaris, run by Oya Helin Dundar at 1 site in Turkey (Türkiye).
Trial summary
The goal of this randomized, triple-blind, vehicle-controlled clinical trial is to evaluate whether topical 7.5% dapsone gel is effective for treating mild-to-moderate acne vulgaris in adults. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Dapsone 7.5% gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jun 2025to 1 Mar 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18 to 50 years with a clinical diagnosis of mild-to-moderate acne vulgaris.
- No systemic or topical acne treatment within the past 1 month (30 days).
- Able and willing to provide written informed consent.
Who cannot join
- Pregnancy or breastfeeding.
- Systemic retinoid or systemic antibiotic use within the past 6 months.
- Active dermatologic or systemic disease that could interfere with study participation or outcome assessments.
- Known hypersensitivity to dapsone or any component of the study product.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Training and Research Hospital
Istanbul, 34000
About this study
Official title: Randomized, Triple-Blind, Vehicle-Controlled Trial Evaluating Clinical Efficacy, Sebum, Erythema, Melanin and Quality-of-Life Outcomes of Topical Dapsone Gel 7.5% in Patients With Acne Vulgaris
The goal of this randomized, triple-blind, vehicle-controlled clinical trial is to evaluate whether topical 7.5% dapsone gel is effective for treating mild-to-moderate acne vulgaris in adults.
The main questions are:
Read more
- Does dapsone gel improve global acne severity compared with a matched vehicle gel?
- Does dapsone gel improve comedonal and papulopustular acne severity?
- Does dapsone gel reduce erythema and melanin indices measured with a Mexameter, and sebum index measured with a Sebumeter?
- Does treatment with dapsone gel improve patients' acne-related quality of life?
Researchers compared once-daily dapsone gel with a matched vehicle gel without the active ingredient.
Participants:
- Applied either dapsone gel or vehicle gel once daily for 8 weeks
- Attended clinic visits at baseline, week 4, week 8, and week 12
- Had acne severity assessed using the Global Acne Grading System and Plewig and Kligman comedonal and papulopustular stages
- Had erythema and melanin measured with a Mexameter, and sebum measured with a Sebumeter at predefined facial sites
- Completed an acne quality-of-life questionnaire at baseline and week 8
- Had standardized photographs taken at each visit
Treatment was continued for 8 weeks, followed by a 4-week treatment-free follow-up through week 12.
Read the detailed description
This is a prospective, randomized, triple-blind, vehicle-controlled clinical trial designed to evaluate the clinical efficacy of topical 7.5% dapsone gel in adults with mild-to-moderate acne vulgaris. The study also investigates the effects of topical dapsone on skin biophysical parameters using standardized instruments: erythema and melanin indices measured with a Mexameter, and sebum index measured with a Sebumeter.
Two parallel arms were included: one group applied topical 7.5% dapsone gel once daily, and the other applied a matched vehicle gel identical in base, tube, and packaging but without the active ingredient. Randomization was performed using a pre-generated computer-based randomization sequence. Participants, dispensing investigators, outcome assessors, and data analysts were blinded to treatment allocation.
Participants attended clinic visits at baseline, week 4, week 8, and week 12. Treatment was applied for 8 weeks, followed by a 4-week treatment-free follow-up period through week 12. At each visit, standardized digital photographs were taken, and acne severity was assessed using the Global Acne Grading System (GAGS), lesion counts used to assign Plewig and Kligman comedonal and papulopustular stages, and standardized clinical evaluation. At each visit, Mexameter readings for erythema and melanin and Sebumeter readings for sebum were obtained at three predefined facial sites: right cheek, left cheek, and forehead. Triplicate measurements were obtained at each site after a standardized acclimatization period. The Turkish-validated Gupta Acne Quality of Life Scale was administered at baseline and week 8.
The primary objective was to determine whether topical 7.5% dapsone gel reduces inflammatory lesion burden compared with matched vehicle at week 8. Secondary evaluations included changes in Global Acne Grading System (GAGS) total score, comedonal acne stage, sebum index, erythema index, melanin index, acne-related quality of life, and local cutaneous adverse events. By combining standardized clinical assessments, patient-reported outcomes, and objective biophysical measurements, this trial aimed to evaluate the clinical and biophysical effects of topical 7.5% dapsone gel in acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- Dapsone 7.5% gel, Vehicle gel
- Keywords
- Dapsone gel, Topical dapsone 7.5%, Vehicle gel, Mexameter, Erythema, Sebum, Sebumeter, Melanin, Global Acne Grading System (GAGS), Acne Lesion Count, Papulopustular acne, Comedonal acne, Acne Quality of Life Scale (AQOL)
- Medical subject headings
- Acne Vulgaris, Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapsone 7.5% gelDrug
Also called topical dapsone 7.5% gel, Vulgarex (country-specific brand)
Topical dapsone 7.5% gel applied once daily to the entire face for 8 weeks; route: topical. The study product was supplied in an identical-appearing tube to maintain masking. Participants were followed for 4 weeks after treatment discontinuation.
Vehicle gelDrug
Also called placebo gel
Vehicle gel without dapsone, identical in base, tube, and packaging to the active product; applied once daily to the entire face for 8 weeks; route: topical. Participants were followed for 4 weeks after treatment discontinuation.
| Study group | Role | What they receive |
|---|---|---|
| Dapsone 7.5% Gel | Experimental | Topical dapsone 7.5% gel applied once daily to the entire face for 8 weeks, followed by a 4-week treatment-free follow-up. Receives: Drug: Dapsone 7.5% gel |
| Vehicle Gel | Placebo comparator | Vehicle gel without dapsone, identical in base, tube, and packaging to the active product; applied once daily to the entire face for 8 weeks, followed by a 4-week treatment-free follow-up. Receives: Drug: Vehicle gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Inflammatory Lesion Count (Papules/Pustules)
Mean change from baseline in the number of inflammatory facial acne lesions (papules and pustules) per Plewig \& Kligman. Blinded dermatologist, standardized facial mapping. Between-group comparison: topical 7.5% dapsone gel vs vehicle/placebo gel.
Measured: Baseline to Week 8 (with interim assessment at Week 4)
Secondary outcomes (7)
Change in Global Acne Grading System (GAGS) Total Score
Change from baseline in Global Acne Grading System (GAGS; Doshi et al.) total score. Higher scores indicate more severe acne; a decrease reflects improvement. Between-group comparisons were performed at the end of treatment (week 8) and after the 4-week treatment-free follow-up (week 12).
Measured: Baseline to Week 12, with interim assessments at Week 4 and Week 8
Change in Plewig and Kligman Comedonal Acne Stage
Change from baseline in comedonal acne stage assigned according to Plewig and Kligman grading. Lower stages indicate less severe comedonal acne; a decrease reflects improvement. Between-group comparisons were performed at the end of treatment (week 8) and after the 4-week treatment-free follow-up (week 12).
Measured: Baseline to Week 12, with interim assessments at Week 4 and Week 8
Change in Erythema Index (Mexameter)
Change from baseline in facial erythema index measured with a Mexameter at three predefined facial sites: right cheek, left cheek, and forehead. Triplicate readings were obtained at each site after a standardized acclimatization period and averaged per visit. Between-group comparisons were performed at the end of treatment (week 8) and after the 4-week treatment-free follow-up (week 12).
Measured: Baseline to Week 12, with interim assessments at Week 4 and Week 8
Change in Melanin Index (Mexameter)
Change from baseline in facial melanin index measured with a Mexameter at three predefined facial sites: right cheek, left cheek, and forehead. Triplicate readings were obtained at each site after a standardized acclimatization period and averaged per visit. Between-group comparisons were performed at the end of treatment (week 8) and after the 4-week treatment-free follow-up (week 12).
Measured: Baseline to Week 12, with interim assessments at Week 4 and Week 8
Change in Sebum Index (Sebumeter)
Change from baseline in facial sebum index measured with a Sebumeter at three predefined facial sites: right cheek, left cheek, and forehead. Triplicate readings were obtained at each site and averaged per visit. Between-group comparisons were performed at the end of treatment (week 8) and after the 4-week treatment-free follow-up (week 12).
Measured: Baseline to Week 12, with interim assessments at Week 4 and Week 8
Change in Acne Quality of Life Scale (AQOL) Score
Change from baseline in Turkish-validated Acne Quality of Life Scale (AQOL) score (Gupta et al). Lower scores indicate better quality of life; a decrease reflects improvement. Between-group comparison.
Measured: Baseline to Week 8
Incidence and Severity of Local Cutaneous Adverse Events
Number and proportion of participants with treatment-emergent local cutaneous adverse events, including erythema, desquamation, scaling, burning, and tingling, graded for severity and relatedness.
Measured: Baseline to Week 12, with interim assessments at Week 4 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start17 Jun 2025
- Primary completion1 Feb 2026
- Study completion1 Mar 2026
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned to one of two parallel treatment arms in a 1:1 ratio: topical dapsone 7.5% gel or matched vehicle gel. Treatment was applied once daily for 8 weeks, followed by a 4-week treatment-free follow-up period.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oya Helin Dundar
- Sponsor type
- Other government
- Collaborators
- Istanbul Training and Research Hospital
- Responsible party
- Sponsor-investigator, Oya Helin Dundar, Istanbul Training and Research Hospital
- Investigators
- Oya Helin Dundar, MD, Principal investigator, Istanbul Training and Research Hospital, Dept. of DermatologyVildan Manav, MD, Assoc. Prof., Study director, Istanbul Training and Research Hospital, Dept. of DermatologyAyse Esra Koku Aksu, MD, Prof., Study chair, Istanbul Training and Research Hospital, Dept. of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244887
- Sponsor's protocol ID
- SBU-IEAH-AV-DAP7P5-RCT-EC210
- Other IDs
- Medipol-EC-210
- Status last verified
- May 2026
- First submitted
- 10 Sep 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Triple-Blind, Vehicle-Controlled Trial Evaluating Clinical Efficacy, Sebum, Erythema, Melanin and Quality-of-Life Outcomes of Topical Dapsone Gel 7.5% in Patients With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT07244887
- Acronym / sponsor ID
- SBU-IEAH-AV-DAP7P5-RCT-EC210
- Conditions
- Acne Vulgaris
- Keywords
- Dapsone gel, Topical dapsone 7.5%, Vehicle gel, Mexameter, Erythema, Sebum, Sebumeter, Melanin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Oya Helin DundarOther government
- Collaborators
- Istanbul Training and Research Hospital
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 24 Nov 2025 (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.
The goal of this randomized, triple-blind, vehicle-controlled clinical trial is to evaluate whether topical 7.5% dapsone gel is effective for treating mild-to-moderate acne vulgaris in adults.
The main questions are:
- Does dapsone gel improve global acne severity compared with a matched vehicle gel?
- Does dapsone gel improve comedonal and papulopustular acne severity?
- Does dapsone gel reduce erythema and melanin indices measured with a Mexameter, and sebum index measured with a Sebumeter?
- Does treatment with dapsone gel improve patients' acne-related quality of life?
Researchers compared once-daily dapsone gel with a matched vehicle gel without the active ingredient.
Participants:
- Applied either dapsone gel or vehicle gel once daily for 8 weeks
- Attended clinic visits at baseline, week 4, week 8, and week 12
- Had acne severity assessed using the Global Acne Grading System and Plewig and Kligman comedonal and papulopustular stages
- Had erythema and melanin measured with a Mexameter, and sebum measured with a Sebumeter at predefined facial sites
- Completed an acne quality-of-life questionnaire at baseline and week 8
- Had standardized photographs taken at each visit
Treatment was continued for 8 weeks, followed by a 4-week treatment-free follow-up through week 12.
Detailed description
This is a prospective, randomized, triple-blind, vehicle-controlled clinical trial designed to evaluate the clinical efficacy of topical 7.5% dapsone gel in adults with mild-to-moderate acne vulgaris. The study also investigates the effects of topical dapsone on skin biophysical parameters using standardized instruments: erythema and melanin indices measured with a Mexameter, and sebum index measured with a Sebumeter.
Two parallel arms were included: one group applied topical 7.5% dapsone gel once daily, and the other applied a matched vehicle gel identical in base, tube, and packaging but without the active ingredient. Randomization was performed using a pre-generated computer-based randomization sequence. Participants, dispensing investigators, outcome assessors, and data analysts were blinded to treatment allocation.
Participants attended clinic visits at baseline, week 4, week 8, and week 12. Treatment was applied for 8 weeks, followed by a 4-week treatment-free follow-up period through week 12. At each visit, standardized digital photographs were taken, and acne severity was assessed using the Global Acne Grading System (GAGS), lesion counts used to assign Plewig and Kligman comedonal and papulopustular stages, and standardized clinical evaluation. At each visit, Mexameter readings for erythema and melanin and Sebumeter readings for sebum were obtained at three predefined facial sites: right cheek, left cheek, and forehead. Triplicate measurements were obtained at each site after a standardized acclimatization period. The Turkish-validated Gupta Acne Quality of Life Scale was administered at baseline and week 8.
The primary objective was to determine whether topical 7.5% dapsone gel reduces inflammatory lesion burden compared with matched vehicle at week 8. Secondary evaluations included changes in Global Acne Grading System (GAGS) total score, comedonal acne stage, sebum index, erythema index, melanin index, acne-related quality of life, and local cutaneous adverse events. By combining standardized clinical assessments, patient-reported outcomes, and objective biophysical measurements, this trial aimed to evaluate the clinical and biophysical effects of topical 7.5% dapsone gel in acne vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were assigned to one of two parallel treatment arms in a 1:1 ratio: topical dapsone 7.5% gel or matched vehicle gel. Treatment was applied once daily for 8 weeks, followed by a 4-week treatment-free follow-up period.
| Arm | Type | Receives |
|---|---|---|
| Dapsone 7.5% Gel | Experimental | Drug: Dapsone 7.5% gelTopical dapsone 7.5% gel applied once daily to the entire face for 8 weeks, followed by a 4-week treatment-free follow-up. |
| Vehicle Gel | Placebo comparator | Drug: Vehicle gelVehicle gel without dapsone, identical in base, tube, and packaging to the active product; applied once daily to the entire face for 8 weeks, followed by a 4-week treatment-free follow-up. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults aged 18 to 50 years with a clinical diagnosis of mild-to-moderate acne vulgaris.
- No systemic or topical acne treatment within the past 1 month (30 days).
- Able and willing to provide written informed consent.
Key exclusion criteria (4 listed)
- Pregnancy or breastfeeding.
- Systemic retinoid or systemic antibiotic use within the past 6 months.
- Active dermatologic or systemic disease that could interfere with study participation or outcome assessments.
- Known hypersensitivity to dapsone or any component of the study product.
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 |
|---|---|---|
| Dapsone 7.5% gelAlso: topical dapsone 7.5% gel, Vulgarex (country-specific brand)Topical dapsone 7.5% gel applied once daily to the entire face for 8 weeks; route: topical. The study product was supplied in an identical-appearing tube to maintain masking. Participants were followed for 4 weeks after treatment discontinuation. | Drug | Dapsone 7.5% Gel |
| Vehicle gelAlso: placebo gelVehicle gel without dapsone, identical in base, tube, and packaging to the active product; applied once daily to the entire face for 8 weeks; route: topical. Participants were followed for 4 weeks after treatment discontinuation. | Drug | Vehicle Gel |
Primary outcome
Change in Inflammatory Lesion Count (Papules/Pustules)
Time frame: Baseline to Week 8 (with interim assessment at Week 4)
Mean change from baseline in the number of inflammatory facial acne lesions (papules and pustules) per Plewig \& Kligman. Blinded dermatologist, standardized facial mapping. Between-group comparison: topical 7.5% dapsone gel vs vehicle/placebo gel.
7 secondary outcomes
Change in Global Acne Grading System (GAGS) Total Score
Time frame: Baseline to Week 12, with interim assessments at Week 4 and Week 8
Change in Plewig and Kligman Comedonal Acne Stage
Time frame: Baseline to Week 12, with interim assessments at Week 4 and Week 8
Change in Erythema Index (Mexameter)
Time frame: Baseline to Week 12, with interim assessments at Week 4 and Week 8
Change in Melanin Index (Mexameter)
Time frame: Baseline to Week 12, with interim assessments at Week 4 and Week 8
Change in Sebum Index (Sebumeter)
Time frame: Baseline to Week 12, with interim assessments at Week 4 and Week 8
Change in Acne Quality of Life Scale (AQOL) Score
Time frame: Baseline to Week 8
Incidence and Severity of Local Cutaneous Adverse Events
Time frame: Baseline to Week 12, with interim assessments at Week 4 and Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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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. This study is not recruiting at the moment.
Oya Helin Dundar, MD principal investigator
Istanbul Training and Research Hospital, Dept. of Dermatology
Vildan Manav, MD, Assoc. Prof. study director
Istanbul Training and Research Hospital, Dept. of Dermatology
Ayse Esra Koku Aksu, MD, Prof. study chair
Istanbul Training and Research Hospital, Dept. of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapsone 7.5% gel in people with Acne Vulgaris, run by Oya Helin Dundar at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 22 May 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Inflammatory Lesion Count (Papules/Pustules) (time frame: Baseline to Week 8 (with interim assessment at Week 4)). 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 22 May 2026.