RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to demonstrate the safety and efficacy of Sirolimus 0.2% topical gel for patients with Acanthosis Nigricans

Official Title

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

Quick Facts

Study Start:2025-03-01

Study Completion:2025-07-18

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06940895

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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 mTOR inhibitory action within 12 months prior to the first visit. * Subjects with a malignant tumor

Inclusion Criteria

Exclusion 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.

* 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 mTOR inhibitory action within 12 months prior to the first visit.
* Subjects with a malignant tumor

Contacts and Locations

Study Contact

Kayla Zafar, BA

CONTACT

718-836-6600

kaylazafar@yahoo.com

Principal Investigator

Jared Jagdeo, MD MS

PRINCIPAL_INVESTIGATOR

SUNY Downstate Health Sciences University Department of Dermatology

Study Locations (Sites)

New York Harbor VA Brooklyn Campus

Brooklyn, New York, 11209

United States

Collaborators and Investigators

Sponsor: Narrows Institute for Biomedical Research

Jared Jagdeo, MD MS, PRINCIPAL_INVESTIGATOR, SUNY Downstate Health Sciences University Department of Dermatology

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 Registration Dates

Study Start Date2025-03-01

Study Completion Date2025-07-18

Study Record Updates

Study Start Date2025-03-01

Study Completion Date2025-07-18

Terms related to this study

Keywords Provided by Researchers

acanthosis nigricans

Additional Relevant MeSH Terms

Acanthosis Nigricans