Acne VulgarisPhase 4CLASCO-ACNENCT07881315
Clascoterone Versus Clindamycin Added to Adapalene/Benzoyl Peroxide for Moderate Facial Acne
A Phase 4 study testing Clascoterone 1% cream, Clindamycin 1% lotion and Adapalene 0.1%/benzoyl peroxide 2.5% gel in people with Acne Vulgaris, run by Allied Hospital Faisalabad at 1 site in Pakistan.
Trial summary
This randomised trial compares two treatments added to the same standard acne gel in people with moderate facial acne. All participants will use adapalene 0.1%/benzoyl peroxide 2.5% gel at night. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Clascoterone 1% cream, Clindamycin 1% lotion and Adapalene 0.1%/benzoyl peroxide 2.5% gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 sitePakistan
- Study dates
- Nov 2026to May 2027
- Phase
- Phase 4
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 15 years or older, either sex
- Moderate facial acne (Investigator's Global Assessment grade 3)
- At least 20 inflammatory and 10 non-inflammatory facial lesions, with no more than one small nodule
- Negative urine pregnancy test, if applicable
- Written informed consent (parent/guardian consent and participant assent for those aged 15-17 years)
Who cannot join
- Severe, nodulocystic, drug-induced or steroid-induced acne
- Pregnancy, lactation, or unwillingness to use contraception
- Oral isotretinoin within 6 months, oral antibiotics within 4 weeks, or topical acne treatment within 2 weeks
- Hormonal therapy started or changed within 3 months
- Systemic or facial topical corticosteroid within 4 weeks
- Known adrenal disorder
Show all 9Show fewer
- Inflammatory bowel disease or antibiotic-associated colitis
- Hypersensitivity to any study drug
- Other facial skin disease interfering with lesion counting
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Allied Hospital, Faisalabad
Faisalabad, Punjab Province, 38000
About this study
Official title: Clascoterone Versus Clindamycin as an Adjunct to Adapalene/Benzoyl Peroxide in Moderate Facial Acne: A Randomised, Assessor-Blinded Comparative Trial
This randomised trial compares two treatments added to the same standard acne gel in people with moderate facial acne. All participants will use adapalene 0.1%/benzoyl peroxide 2.5% gel at night. Half will also use clascoterone 1% cream (a non-antibiotic cream that blocks the effect of androgen hormones in the skin), and half will use clindamycin 1% lotion (a topical antibiotic), twice daily for 12 weeks. The main question is whether the reduction in inflamed acne spots (papules and pustules) after 12 weeks differs between the two groups. Secondary questions cover non-inflamed spots, overall clearance, skin irritation, side effects and patient satisfaction. A dermatologist who does not know which treatment each participant receives will count the acne spots at the start and at weeks 4, 8 and 12. Because antibiotic resistance in acne bacteria is increasing, the study will provide local evidence on whether a non-antibiotic option can be used as an alternative partner to standard acne treatment.
Read the detailed description
Design: single-centre, randomised, assessor-blinded, parallel-group comparative trial with 1:1 allocation, conducted in the dermatology outpatient department of Allied Hospital, Faisalabad, Pakistan.
Participants: 118 patients aged 15 years or older with moderate facial acne (Investigator's Global Assessment grade 3), recruited consecutively. Written informed consent is obtained from all participants, with parent or guardian consent plus participant assent for those aged 15-17 years.
Randomisation and concealment: computer-generated sequence in randomly varying blocks of 4 and 6, stratified by sex, with separate sequences for men and women. The list is held by a person not involved in recruitment or assessment, who discloses each allocation only after enrolment and baseline assessment.
Interventions (12 weeks): Group A, adapalene 0.1%/BPO 2.5% gel at night plus clascoterone 1% cream twice daily. Group B, adapalene 0.1%/BPO 2.5% gel at night plus clindamycin 1% lotion twice daily. In the evening the gel is applied first and the partner drug 10-15 minutes later. Application is demonstrated at baseline with a standard instruction sheet. Moderate irritation is managed by reducing the gel to alternate nights for up to 7 days, and, if irritation persists, the partner drug may be paused for up to 7 days in either group.
Assessments: lesion counts, IGA (US FDA scale) and local tolerability at baseline and weeks 4, 8 and 12 by a dermatologist blinded to allocation. A separate team member dispenses medication and records adverse events and adherence.
Sample size: with a standard deviation of 34.7 for percentage change in inflammatory lesions (adapalene/BPO arm, NCT00422240), 48 participants per group give 80% power (two-sided alpha 0.05) to detect a prespecified target difference of 20 percentage points. This was increased to 50 per group, and to 59 per group (118 in total) to allow for 15% drop-out.
Analysis: the primary outcome is compared by independent-samples t-test (mean difference with 95% confidence interval), with the Mann-Whitney U test as supportive. The primary analysis is available-case by randomised group. Sensitivity analyses: (i) linear regression adjusted for baseline inflammatory count and sex; (ii) missing week-12 counts assumed to show no improvement. Categorical outcomes are compared by chi-square or Fisher's exact test.
- Conditions
- Acne Vulgaris
- Being tested
- Clascoterone 1% cream, Clindamycin 1% lotion, Adapalene 0.1%/benzoyl peroxide 2.5% gel
- Keywords
- Aclascoterone; clindamycin; adapalene; benzoyl peroxide; topical androgen receptor inhibitor; antibiotic resistance; 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.
Clascoterone 1% creamDrug
Topical androgen receptor inhibitor applied as a thin layer to the whole face twice daily for 12 weeks, in addition to adapalene/benzoyl peroxide gel at night.
Clindamycin 1% lotionDrug
Topical lincosamide antibiotic applied as a thin layer to the whole face twice daily for 12 weeks, in addition to adapalene/benzoyl peroxide gel at night.
Adapalene 0.1%/benzoyl peroxide 2.5% gelDrug
Fixed-combination topical retinoid and benzoyl peroxide gel applied once nightly to the whole face for 12 weeks as background treatment in both arms.
| Study group | Role | What they receive |
|---|---|---|
| Clascoterone + Adapalene/BPO | Experimental | Adapalene 0.1%/benzoyl peroxide 2.5% gel once nightly plus clascoterone 1% cream applied as a thin layer to the whole face twice daily for 12 weeks. Receives: Drug: Clascoterone 1% cream; Drug: Adapalene 0.1%/benzoyl peroxide 2.5% gel |
| Clindamycin + Adapalene/BPO | Active comparator | Adapalene 0.1%/benzoyl peroxide 2.5% gel once nightly plus clindamycin 1% lotion applied as a thin layer to the whole face twice daily for 12 weeks. Receives: Drug: Clindamycin 1% lotion; Drug: Adapalene 0.1%/benzoyl peroxide 2.5% gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in inflammatory lesion count
Papules and pustules counted on the face. Calculated as (baseline - week 12) ÷ baseline × 100.
Measured: Baseline to week 12
Secondary outcomes (6)
Percentage change in non-inflammatory lesion count
Measured: Open and closed comedones counted on the face. Calculated as (baseline - week 12) ÷ baseline × 100.
Percentage change in total lesion count
Inflammatory plus non-inflammatory lesions counted on the face. Calculated as (baseline - week 12) ÷ baseline × 100.
Measured: Baseline to week 12
IGA success
Proportion of participants with Investigator's Global Assessment (IGA) of 0 (clear) or 1 (almost clear) and at least a two-grade improvement from baseline, on the 0-4 scale
Measured: Week 12
Local tolerability
Erythema, scaling, dryness and burning/stinging, each graded 0 (none) to 3 (severe) by the investigator.
Measured: Weeks 4, 8 and 12
Number of participants with adverse events
Any adverse event reported or observed during treatment, recorded at each visit.
Measured: Baseline to week 12
Patient satisfaction
Rated by the participant on a five-point scale from very dissatisfied to very satisfied
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allied Hospital Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Amara Safdar, Allied Hospital Faisalabad
- Investigators
- Amara safdar Safdar, MBBS, FCPS, Principal investigator, Allied Hospital, Faisalabad Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881315
- Sponsor's protocol ID
- CLASCO-ACNE-2026
- Acronym
- CLASCO-ACNE
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly. De-identified data may be made available by the principal investigator on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clascoterone Versus Clindamycin as an Adjunct to Adapalene/Benzoyl Peroxide in Moderate Facial Acne: A Randomised, Assessor-Blinded Comparative Trial
- ClinicalTrials.gov ID
- NCT07881315
- Acronym / sponsor ID
- CLASCO-ACNE / CLASCO-ACNE-2026
- Conditions
- Acne Vulgaris
- Keywords
- Aclascoterone; clindamycin; adapalene; benzoyl peroxide; topical androgen receptor inhibitor; antibiotic resistance; moderate acne
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Allied Hospital FaisalabadUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 19 Oct 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 randomised trial compares two treatments added to the same standard acne gel in people with moderate facial acne. All participants will use adapalene 0.1%/benzoyl peroxide 2.5% gel at night. Half will also use clascoterone 1% cream (a non-antibiotic cream that blocks the effect of androgen hormones in the skin), and half will use clindamycin 1% lotion (a topical antibiotic), twice daily for 12 weeks. The main question is whether the reduction in inflamed acne spots (papules and pustules) after 12 weeks differs between the two groups. Secondary questions cover non-inflamed spots, overall clearance, skin irritation, side effects and patient satisfaction. A dermatologist who does not know which treatment each participant receives will count the acne spots at the start and at weeks 4, 8 and 12. Because antibiotic resistance in acne bacteria is increasing, the study will provide local evidence on whether a non-antibiotic option can be used as an alternative partner to standard acne treatment.
Detailed description
Design: single-centre, randomised, assessor-blinded, parallel-group comparative trial with 1:1 allocation, conducted in the dermatology outpatient department of Allied Hospital, Faisalabad, Pakistan.
Participants: 118 patients aged 15 years or older with moderate facial acne (Investigator's Global Assessment grade 3), recruited consecutively. Written informed consent is obtained from all participants, with parent or guardian consent plus participant assent for those aged 15-17 years.
Randomisation and concealment: computer-generated sequence in randomly varying blocks of 4 and 6, stratified by sex, with separate sequences for men and women. The list is held by a person not involved in recruitment or assessment, who discloses each allocation only after enrolment and baseline assessment.
Interventions (12 weeks): Group A, adapalene 0.1%/BPO 2.5% gel at night plus clascoterone 1% cream twice daily. Group B, adapalene 0.1%/BPO 2.5% gel at night plus clindamycin 1% lotion twice daily. In the evening the gel is applied first and the partner drug 10-15 minutes later. Application is demonstrated at baseline with a standard instruction sheet. Moderate irritation is managed by reducing the gel to alternate nights for up to 7 days, and, if irritation persists, the partner drug may be paused for up to 7 days in either group.
Assessments: lesion counts, IGA (US FDA scale) and local tolerability at baseline and weeks 4, 8 and 12 by a dermatologist blinded to allocation. A separate team member dispenses medication and records adverse events and adherence.
Sample size: with a standard deviation of 34.7 for percentage change in inflammatory lesions (adapalene/BPO arm, NCT00422240), 48 participants per group give 80% power (two-sided alpha 0.05) to detect a prespecified target difference of 20 percentage points. This was increased to 50 per group, and to 59 per group (118 in total) to allow for 15% drop-out.
Analysis: the primary outcome is compared by independent-samples t-test (mean difference with 95% confidence interval), with the Mann-Whitney U test as supportive. The primary analysis is available-case by randomised group. Sensitivity analyses: (i) linear regression adjusted for baseline inflammatory count and sex; (ii) missing week-12 counts assumed to show no improvement. Categorical outcomes are compared by chi-square or Fisher's exact test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clascoterone + Adapalene/BPO | Experimental | Drug: Clascoterone 1% cream, Drug: Adapalene 0.1%/benzoyl peroxide 2.5% gelAdapalene 0.1%/benzoyl peroxide 2.5% gel once nightly plus clascoterone 1% cream applied as a thin layer to the whole face twice daily for 12 weeks. |
| Clindamycin + Adapalene/BPO | Active comparator | Drug: Clindamycin 1% lotion, Drug: Adapalene 0.1%/benzoyl peroxide 2.5% gelAdapalene 0.1%/benzoyl peroxide 2.5% gel once nightly plus clindamycin 1% lotion applied as a thin layer to the whole face twice daily for 12 weeks. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age 15 years or older, either sex
- Moderate facial acne (Investigator's Global Assessment grade 3)
- At least 20 inflammatory and 10 non-inflammatory facial lesions, with no more than one small nodule
- Negative urine pregnancy test, if applicable
- Written informed consent (parent/guardian consent and participant assent for those aged 15-17 years)
Key exclusion criteria (9 listed)
- Severe, nodulocystic, drug-induced or steroid-induced acne
- Pregnancy, lactation, or unwillingness to use contraception
- Oral isotretinoin within 6 months, oral antibiotics within 4 weeks, or topical acne treatment within 2 weeks
- Hormonal therapy started or changed within 3 months
- Systemic or facial topical corticosteroid within 4 weeks
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 |
|---|---|---|
| Clascoterone 1% creamTopical androgen receptor inhibitor applied as a thin layer to the whole face twice daily for 12 weeks, in addition to adapalene/benzoyl peroxide gel at night. | Drug | Clascoterone + Adapalene/BPO |
| Clindamycin 1% lotionTopical lincosamide antibiotic applied as a thin layer to the whole face twice daily for 12 weeks, in addition to adapalene/benzoyl peroxide gel at night. | Drug | Clindamycin + Adapalene/BPO |
| Adapalene 0.1%/benzoyl peroxide 2.5% gelFixed-combination topical retinoid and benzoyl peroxide gel applied once nightly to the whole face for 12 weeks as background treatment in both arms. | Drug | Clascoterone + Adapalene/BPO, Clindamycin + Adapalene/BPO |
Primary outcome
Percentage change in inflammatory lesion count
Time frame: Baseline to week 12
Papules and pustules counted on the face. Calculated as (baseline - week 12) ÷ baseline × 100.
6 secondary outcomes
Percentage change in non-inflammatory lesion count
Time frame: Open and closed comedones counted on the face. Calculated as (baseline - week 12) ÷ baseline × 100.
Percentage change in total lesion count
Time frame: Baseline to week 12
IGA success
Time frame: Week 12
Local tolerability
Time frame: Weeks 4, 8 and 12
Number of participants with adverse events
Time frame: Baseline to week 12
Patient satisfaction
Time frame: Week 12
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 19 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly. De-identified data may be made available by the principal investigator on reasonable request.
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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.
Amara safdar Safdar, MBBS, FCPS principal investigator
Allied Hospital, Faisalabad Medical University
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 Clascoterone 1% cream, Clindamycin 1% lotion and Adapalene 0.1%/benzoyl peroxide 2.5% gel in people with Acne Vulgaris, run by Allied Hospital Faisalabad at 1 site in Pakistan.
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: opening soon, as of the sponsor's last update on 19 Oct 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 Pakistan. 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.
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?
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 Amara Safdar Safdar, MBBS, FCPS (+923333002797, Amarasafdar@pmc.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change 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 19 Oct 2026.