Trial · NCT06336603
A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Adapalene 0.3% for the Treatment of Acne
NCT06336603, Phase 4, Completed, Sun Pharmaceutical Industries Limited; results first posted 2025-10-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Adapalene 0.3% for the Treatment of Acne. Trials, record NCT06336603. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06336603
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Adapalene 0.3% for the Treatment of Acne
- NCT number
- NCT06336603
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 20 participants, actual
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Conditions
- Acne Vulgaris
- Interventions
- Winlevi (clascoterone) 1% & Adapalene 0.3% gel
- First posted
- 2024-03-29
- Last updated
- 2025-10-09
- Results first posted
- 2025-10-09
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Primary Endpoint of This Study is the Percent of Patients Who Achieve Clear or Almost Clear on IGA at Week 16. | Week 16 | The investigator will evaluate global acne severity using the Investigator Global Assessment scale, which ranges from 0 to 5, where 0 represents clear skin and 5 represents very severe acne |
| Secondary | Percent of Total Lesion Reduction at Week 16 Compared to Baseline | Week 16 | |
| Secondary | Percent of Inflammatory Lesion Reduction at Week 16 Compared to Baseline | Week 16 | |
| Secondary | Percent of Non-inflammatory Lesion Reduction at Week 16 Compared to Baseline | Week 16 | |
| Secondary | Tolerability Measures of Erythema Based on 5-point Severity Scale | Week 4,8,12,16, 20 | The score in the scale ranges from 0-4. Lower score represents absence of erythema and higher score represents severe condition. The information presented represents the "Percentage of participant" with "Absent or Trace" erythema at weeks 4,8,12, 16 and 20 |
| Secondary | Tolerability Measures of Dryness Based on 5-point Severity Scale | Week 4,8,12,16, 20 | The score in the scale ranges from 0-4. Lower score represents absence of dryness and higher score represents severe condition. The information presented represents the "Percentage of participant" with "Absent or Trace" Dryness at weeks 4,8,12, 16 and 20 |
| Secondary | Tolerability Measures of Peeling Based on 5-point Severity Scale | Week 4,8,12,16, 20 | The score in the scale ranges from 0-4. Score 0 represents absence of peeling and Score 4 represents 'Extensive peeling'. The information presented represents the "Percentage of participant" with "Absent or Trace" peeling at weeks 4,8,12,16 and 20 |
| Secondary | Assessment of Skin Oiliness Based on 5-point Severity Scale | Week 4,8,12,16, 20 | The score in the scale ranges from 0-4. Score 0 represents absence of Oiliness and Score 4 represents severe condition. The information presented represents the "Percentage of participant" with "Absent or Trace" oiliness at weeks 4,8,12,16 and 20 |
| Secondary | Tolerability Measures of Burning/Stinging Based on 6-point Severity Scale | Week 4,8,12,16, 20 | The score in the scale ranges from 0-5. Lower score represents absence of discomfort and higher score represents severe condition. The information presented represents the "Percentage of participant" with "Absent or Trace" burning/stinging at weeks 4,8,12,16 and 20 |
| Secondary | Tolerability Measures of Pruritus Based on 6-point Severity Scale | Week 4,8,12,16, 20 | The score in the scale ranges from 0-5. Lower score represents absence of discomfort and higher score represents severe condition. The information presented represents the "Percentage of participant" with "Absent or Trace" pruritus at weeks 4,8,12,16 and 20 |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Primary Endpoint of This Study is the Percent of Patients Who Achieve Clear or Almost Clear on IGA at Week 16. | Week 16 | percentage of participants | NUMBER | |
| SECONDARY | Percent of Total Lesion Reduction at Week 16 Compared to Baseline | Week 16 | Percentage change | MEAN | |
| SECONDARY | Percent of Inflammatory Lesion Reduction at Week 16 Compared to Baseline | Week 16 | percentage change | MEAN | |
| SECONDARY | Percent of Non-inflammatory Lesion Reduction at Week 16 Compared to Baseline | Week 16 | percentage change | MEAN | |
| SECONDARY | Tolerability Measures of Erythema Based on 5-point Severity Scale | Week 4,8,12,16, 20 | percentage of participants | NUMBER | |
| SECONDARY | Tolerability Measures of Dryness Based on 5-point Severity Scale | Week 4,8,12,16, 20 | percentage of participants | NUMBER | |
| SECONDARY | Tolerability Measures of Peeling Based on 5-point Severity Scale | Week 4,8,12,16, 20 | percentage of participants | NUMBER | |
| SECONDARY | Assessment of Skin Oiliness Based on 5-point Severity Scale | Week 4,8,12,16, 20 | percentage of participants | NUMBER | |
| SECONDARY | Tolerability Measures of Burning/Stinging Based on 6-point Severity Scale | Week 4,8,12,16, 20 | percentage of participants | NUMBER | |
| SECONDARY | Tolerability Measures of Pruritus Based on 6-point Severity Scale | Week 4,8,12,16, 20 | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Primary Endpoint of This Study is the Percent of Patients Who Achieve Clear or Almost Clear on IGA at Week 16. | Winlevi (Clascoterone) 1% & Adapalene 0.3% Gel | 65 | percentage of participants | ||
| Percent of Total Lesion Reduction at Week 16 Compared to Baseline | Winlevi (Clascoterone) 1% & Adapalene 0.3% Gel | 87.3 | Standard Deviation 11.4 | Percentage change | |
| Percent of Inflammatory Lesion Reduction at Week 16 Compared to Baseline | Winlevi (Clascoterone) 1% & Adapalene 0.3% Gel | 90.5 | Standard Deviation 10.1 | percentage change | |
| Percent of Non-inflammatory Lesion Reduction at Week 16 Compared to Baseline | Winlevi (Clascoterone) 1% & Adapalene 0.3% Gel | 84.8 | Standard Deviation 13.5 | percentage change | |
| Tolerability Measures of Erythema Based on 5-point Severity Scale | Winlevi (Clascoterone) 1% & Adapalene 0.3% Gel | Baseline | 76 | percentage of participants | |
| Tolerability Measures of Erythema Based on 5-point Severity Scale | Winlevi (Clascoterone) 1% & Adapalene 0.3% Gel | Week 4 | 88 | percentage of participants | |
| Tolerability Measures of Erythema Based on 5-point Severity Scale | Winlevi (Clascoterone) 1% & Adapalene 0.3% Gel | Week 8 | 100 | percentage of participants | |
| Tolerability Measures of Erythema Based on 5-point Severity Scale | Winlevi (Clascoterone) 1% & Adapalene 0.3% Gel | Week 12 | 100 | percentage of participants | |
| Tolerability Measures of Erythema Based on 5-point Severity Scale | Winlevi (Clascoterone) 1% & Adapalene 0.3% Gel | Week 16 | 94 | percentage of participants | |
| Tolerability Measures of Erythema Based on 5-point Severity Scale | Winlevi (Clascoterone) 1% & Adapalene 0.3% Gel | Week 20 | 100 | percentage of participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Winlevi (Clascoterone) 1% & Adapalene 0.3% Gel | 20 | |
| Overall Study | COMPLETED | Winlevi (Clascoterone) 1% & Adapalene 0.3% Gel | 17 | |
| Overall Study | NOT COMPLETED | Winlevi (Clascoterone) 1% & Adapalene 0.3% Gel | 3 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Winlevi (Clascoterone) 1% & Adapalene 0.3% Gel | 0 | 17 |
| Total, other adverse events | Winlevi (Clascoterone) 1% & Adapalene 0.3% Gel | 0 | 17 |
| Total, serious adverse events | Winlevi (Clascoterone) 1% & Adapalene 0.3% Gel | 0 | 17 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06336603
GET https://conductscience.org/api/trials/v1/NCT06336603/results?page=2