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NCT06415305 · ClinicalTrials.gov registry record · Phase 4
A Study Evaluating the Efficacy and Safety of Clascoterone Cream 1% in Skin of Color Patients With Acne
A Phase 4 study, sponsored by Sun Pharmaceutical Industries Limited.
- Completed
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
NCT06415305: Completed Phase 4 study, sponsored by Sun Pharmaceutical Industries Limited.
NCT06415305 is a Phase 4 study that has completed, run by Sun Pharmaceutical Industries Limited. The registered enrollment target is 10 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06415305, a Phase 4 study, has completed, sponsored by Sun Pharmaceutical Industries Limited.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
Study Summary
Acne vulgaris is the most common skin disease in patients with skin of color and second most common in Caucasian population. The global prevalence is thought to be as high as 60-80% in individuals 12-25 years of age. However, it is not limited to only teenagers but also to adults, especially adult females. The pathogenesis of acne is multifactorial. Genetics may also play a role. The treatment pathway should be directed to different pathogenic factors including, excessive sebum production, hyper keratinization, P. acnes, and inflammation. Data is limited for skin of color patients in Phase III registration trials. Data is limited because there are few studies that focus on patients with skin of color. Therefore, a unique study dedicated to patients with skin of color in a real-world setting will be welcome to add further evidence to phase III data.
Interventions
- DRUG Winlevi (clascoterone) 1% cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2023-09-01 |
| Est. Completion | 2025-01-30 |
| Phase | Phase 4 |
What the finished NCT06415305 record still lists
NCT06415305 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Winlevi (clascoterone) 1% cream is the first listed.
NCT06415305 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06415305 about?
NCT06415305 is a clinical study titled "A Study Evaluating the Efficacy and Safety of Clascoterone Cream 1% in Skin of Color Patients With Acne". Acne vulgaris is the most common skin disease in patients with skin of color and second most common in Caucasian population. The global prevalence is thought to be as high as 60-80% in individuals 12-25 years of age. However, it is not limited to only teenagers but also to adults, especially adult f...
What is the current status of trial NCT06415305?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2023-09-01. Estimated completion is 2025-01-30.
What interventions are being tested in trial NCT06415305?
The interventions under investigation include: Winlevi (clascoterone) 1% cream (DRUG).
Who is sponsoring clinical trial NCT06415305?
This trial is sponsored by Sun Pharmaceutical Industries Limited, which has 38 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06415305's enrollment target sits among peer trials
10 1940th of 2000 higher than 33 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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