New gel shows promise for dark skin patches

NCT ID NCT06940895

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This small study tested a gel containing sirolimus (0.2%) on 5 adults with acanthosis nigricans, a condition causing dark, thick skin patches. The goal was to see if the gel safely lightens the skin and improves texture over 12 weeks. Researchers measured changes in skin color and a scoring chart for severity.

What this could mean

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

Active substance
sirolimus 0.2% gel
What this could lead to
If it works, this could point toward a topical treatment to lighten and smooth skin affected by acanthosis nigricans.
What could go wrong
This is a very small, early-phase trial with only 5 participants, so results may not apply to everyone. The treatment may not work or could cause skin irritation.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

5 people

The number who actually took part.

Started

Mar 2025

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

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: * Men and women ages 18+. * Clinical diagnosis of acanthosis nigricans. * Available and willing to comply with study instructions and attend all study visits. * Able and willing to provide written and verbal informed consent. Exclusion Criteria: * Subject has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical or systemic therapy. * Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study. * Pregnant, lactating, or is planning to become pregnant during the study. * Subject is currently enrolled in an investigational drug or device study. * Subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (baseline). * Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function. * Subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles. * Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial. * Erosions, ulcers, or other skin lesions within or closely neighboring the AN lesion application site. * Hypersensitivity reactions such as anaphylaxis or angioedema to sirolimus or any component of sirolimus 0.2% topical gel (HYFTOR). * Dyslipidemia (cholesterol level \>300mg/dL or \>7.75mmol/L, triglyceride level \>300 mg/dL or \>3.42 mmol/L). * Subject cannot agree to take appropriate contraception for the duration of the study and 12 weeks after the final dose. * Exclusions apply to those who have used the following topical treatments to treat AN: retinoids, hydroquinones, corticosteroids, or other depigmenting agents within one month prior to the study, or oral retinoids within six months prior to the study, or medications with mammalian target of rapamycin(mTOR) inhibitory action within 12 months prior to the first visit. * Subjects with a malignant tumor

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • New York Harbor VA Brooklyn Campus

    Brooklyn, New York, 11209, United States

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