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NCT06415279 · ClinicalTrials.gov registry record · Phase 4
A Study to Evaluate the Reduction in Sebum (Skin Oil) Induced by Clascoterone Cream 1% in Acne Patients
A Phase 4 study, sponsored by Sun Pharmaceutical Industries Limited.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
NCT06415279 is a Phase 4 study that has completed, run by Sun Pharmaceutical Industries Limited. The registered enrollment target is 40 participants.
The verdict
NCT06415279, a Phase 4 study, has completed, sponsored by Sun Pharmaceutical Industries Limited.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
Study Summary
The etiology of acne is heavily dependent on the production of sebum by the sebaceous glands that results in the growth of the bacteria c. acnes. If no sebum is present, there is no nutritional source for the c. acnes, the bacteria die, and acne resolves. An FDA approved acne medication consisting of clascoterone cream 1% is believed to effectively treat acne due to a decrease in sebum production. This mechanism of action has been postulated based on efficacy observed in the phase III trials that lead to its approval. This research aims to demonstrate the effect of clascoterone cream 1% in sebum reduction.
Interventions
- DRUG Winlevi (clascoterone) 1% cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-02-14 |
| Est. Completion | 2025-02-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06415279
The ClinicalTrials.gov registry entry for NCT06415279 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sun Pharmaceutical Industries Limited, which has 38 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Winlevi (clascoterone) 1% cream is the first listed.
NCT06415279 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06415279 about?
NCT06415279 is a clinical study titled "A Study to Evaluate the Reduction in Sebum (Skin Oil) Induced by Clascoterone Cream 1% in Acne Patients". The etiology of acne is heavily dependent on the production of sebum by the sebaceous glands that results in the growth of the bacteria c. acnes. If no sebum is present, there is no nutritional source for the c. acnes, the bacteria die, and acne resolves. An FDA approved acne medication consisting o...
What is the current status of trial NCT06415279?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2024-02-14. Estimated completion is 2025-02-12.
What interventions are being tested in trial NCT06415279?
The interventions under investigation include: Winlevi (clascoterone) 1% cream (DRUG).
Who is sponsoring clinical trial NCT06415279?
This trial is sponsored by Sun Pharmaceutical Industries Limited, which has 38 total clinical trials registered on ClinicalTrials.gov.
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