A Phase 4 interventional study of Clascoterone 1% cream and Clindamycin 1% lotion in Acne Vulgaris, sponsored by Allied Hospital Faisalabad. Not yet recruiting at 1 site in Pakistan. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Allied Hospital Faisalabad · Phase 4, Interventional, and Treatment
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.
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.
750 studies on the registry are indexed under Acne Vulgaris; 89 are open to participants now.
This study's planned enrollment of 118 is above the median of 69 across 647 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Allied Hospital Faisalabad is the lead sponsor of 9 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
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.
Drug: Clascoterone 1% cream · Drug: Adapalene 0.1%/benzoyl peroxide 2.5% gel
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.
Drug: Clindamycin 1% lotion · Drug: Adapalene 0.1%/benzoyl peroxide 2.5% gel
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.
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.
Drug page: Adapalene
Fixed-combination topical retinoid and benzoyl peroxide gel applied once nightly to the whole face for 12 weeks as background treatment in both arms.
Percentage change in inflammatory lesion count
Papules and pustules counted on the face. Calculated as (baseline - week 12) ÷ baseline × 100.
Time frame: Baseline to week 12
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
Inflammatory plus non-inflammatory lesions counted on the face. Calculated as (baseline - week 12) ÷ baseline × 100.
Time frame: 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
Time frame: Week 12
Local tolerability
Erythema, scaling, dryness and burning/stinging, each graded 0 (none) to 3 (severe) by the investigator.
Time frame: Weeks 4, 8 and 12
Number of participants with adverse events
Any adverse event reported or observed during treatment, recorded at each visit.
Time frame: Baseline to week 12
Patient satisfaction
Rated by the participant on a five-point scale from very dissatisfied to very satisfied
Time frame: Week 12
Plan to share: No — Individual participant data will not be shared publicly. De-identified data may be made available by the principal investigator on reasonable request.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Clascoterone
Allied Hospital Faisalabad