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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: Completed Phase 4 study, sponsored by Sun Pharmaceutical Industries Limited.

NCT06415279 is a Phase 4 study that has completed, run by Sun Pharmaceutical Industries Limited. The registered enrollment target is 40 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The values represents the mean change from baseline. Casual sebum level is measured using a Sebumeter by means of grease-spot photometry. In this method, the measuring head of a cassette probe briefly exposes a section of a mat tape and brings it into contact with the sebum present on the surface of the forehead. As the tape absorbs sebum, it becomes increasingly transparent; conversely, lower levels of sebum result in less transparency. After contact, the tape is inserted into the device, whic

Interventions

  • DRUG Winlevi (clascoterone) 1% cream

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2024-02-14
Est. Completion 2025-02-12
Phase Phase 4

What the finished NCT06415279 record still lists

NCT06415279 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 1 intervention - of which Winlevi (clascoterone) 1% cream is the first listed.

NCT06415279 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT06415279's enrollment target sits among peer trials

40 1397th of 2000 higher than 533 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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Source: ClinicalTrials.gov NCT06415279, the US trial registry maintained by the National Library of Medicine. NCT06415279 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.