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Acne cream aims to shrink oil glands in new study

NCT ID NCT06425900

Disease control Sponsor: Sun Pharmaceutical Industries Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a cream called clascoterone (Winlevi) can shrink oil glands and change the oil on the face in people with acne. Ten adults with oily skin and moderate acne will use the cream twice daily for 3 months. Researchers will take small skin samples to see if the glands get smaller and if the oil's makeup changes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
clascoterone cream 1%
What this could lead to
If it works, this could point toward a treatment that reduces acne by shrinking oil glands and changing oil composition.
What could go wrong
This is a very small early-phase trial with only 10 participants, so results may not apply to everyone. It also requires ongoing cream use, not a one-time fix.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

10 people

The number who actually took part.

Started

Jul 2024

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 35 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Female or male subjects age 18-35 years. 2. Subjects of all Fitzpatrick skin types. 3. Subjects with moderate facial acne and prominent pores indicating sebaceous gland activity. 4. Subjects with oily facial skin. 5. Subjects who agree to use only the study product and nothing else to the face. 6. Subject must possess no scars or tattoos or other confounding dermatologic conditions on the face in the preauricular biopsy sites on the left and right face. 7. Subjects agree not to introduce any new skin care products during the study. 8. No known medical conditions that, in the investigator's opinion, may interfere with study participation. 9. Subjects have signed an Informed Consent Form in compliance with 21CFR Part 50: "Protection of Human Subjects." 10. Subjects are dependable and able to follow directions and willing to comply with the schedule of visits. 11. Subjects in generally good physical and mental health. Exclusion Criteria: 1. Any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin characteristics. 2. Subjects who are not willing to use the assigned study product to their face as instructed. 3. Subjects who have used any topical prescription products on the face for 4 weeks prior to study entry. 4. Subjects who have used any OTC products on the face for 2 weeks. 5. Subjects with clinically significant unstable medical disorders. 6. Subjects who are unwilling or unable to comply with the requirements of the protocol. 7. Subjects who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study. 8. Subjects currently participating in any other clinical trial.

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Conditions

The condition(s) this trial relates to.

acne Acne Vulgaris

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acne vulgaris

Contacts and locations

Locations

  • Dermatology Consulting Services, PLLC

    High Point, North Carolina, 27262, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.