Evaluating the Safety and Efficacy of Topical Sirolimus 0.2% to Treat Acanthosis Nigricans

November 21, 2025 updated by: Narrows Institute for Biomedical Research
The purpose of this study is to demonstrate the safety and efficacy of Sirolimus 0.2% topical gel for patients with Acanthosis Nigricans

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11209
        • New York Harbor VA Brooklyn Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with Acanthosis Nigricans
Patients with the diagnosis of acanthosis nigricans
Drug: Sirolimus 0.2%
sirolimus 0.2% gel
Other Names:
  • HYFTOR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in hyperpigmentation in acanthosis nigricans lesions
Time Frame: From enrollment to end of treatment at 12 weeks
Improvement in the Melanin(M) index from baseline to 12 weeks of treatment. The M index is positively correlated with a darker skin color and ranges from 0-999.
From enrollment to end of treatment at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in hyperpigmentation and skin texture in acanthosis nigricans lesions
Time Frame: Baseline to weeks 4, 8, and 12
Improvement in the ANSC (Acanthosis Nigricans Scoring Chart) from baseline (Day 0) to Visit 2 (Week 4), Visit 3 (Week 8) and Visit 4 (Week 12). ANSC is scored on a scale of 1 to 8 for skin color and 1 to 6 for skin texture. These scores are then combined for a total ANSC score ranging from 2 to 14.
Baseline to weeks 4, 8, and 12
Improvement in the Investigators Global Evaluation (IGE) scale and Patient Global Evaluation (PGE) scale
Time Frame: Baseline to weeks 4, 8, and 12
IGE and PGE are both scored on a 0 to 6 scale: 0 signifies "clear," 1 indicates "almost clear or > 90% improvement," 2 represents "marked improvement or 75% improvement," 3 denotes "moderate improvement or 50% improvement," 4 signifies "mild improvement or 25% improvement," 5 indicates "no change," and 6 means "worsening."
Baseline to weeks 4, 8, and 12
Improvement in the Dermatology Quality of Life (DLQI) scale
Time Frame: From enrollment to end of treatment at 12 weeks
The DLQI ranges from 0 to 30 with higher scores denoting worse quality of life.
From enrollment to end of treatment at 12 weeks
Assessment of patient satisfaction using the Treatment Satisfaction Questionnaire for Medication (TSQM)
Time Frame: Week 12
Assessment of patient satisfaction using the treatment satisfaction questionnaire for medication
Week 12
Digital photography with a TwinFlash RL Clinical Camera to depict clinical improvement of acanthosis nigricans.
Time Frame: Baseline to weeks 4, 8, and 12
Digital photography with a TwinFlash RL Clinical Camera to depict clinical improvement of AN
Baseline to weeks 4, 8, and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Narrows Institute for Biomedical Research

Collaborators

Nobelpharma

Investigators

  • Principal Investigator: Jared Jagdeo, MD MS, SUNY Downstate Health Sciences University Department of Dermatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Actual)

July 8, 2025

Study Completion (Actual)

July 18, 2025

Study Registration Dates

First Submitted

April 15, 2025

First Submitted That Met QC Criteria

April 15, 2025

First Posted (Actual)

April 23, 2025

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 21, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1814310

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

undecided whether IPD will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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