New gel shows promise for dark skin patches
NCT ID NCT06940895
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acanthosis nigricans are added.
By submitting, you agree to our Terms of use
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.