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

NCT06940895 | Completed Phase 2 FDA Drug

• 1 other identifier: 1814310
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acanthosis Nigricans

Keywords

acanthosis nigricans

Outcome Measures

Primary Outcomes (1)

• Improvement in hyperpigmentation in acanthosis nigricans lesions

  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 Outcomes (5)

• Improvement in hyperpigmentation and skin texture in acanthosis nigricans lesions

  Baseline to weeks 4, 8, and 12

• Improvement in the Investigators Global Evaluation (IGE) scale and Patient Global Evaluation (PGE) scale

  Baseline to weeks 4, 8, and 12

• Improvement in the Dermatology Quality of Life (DLQI) scale

  From enrollment to end of treatment at 12 weeks

• Assessment of patient satisfaction using the Treatment Satisfaction Questionnaire for Medication (TSQM)

  Week 12

• Digital photography with a TwinFlash RL Clinical Camera to depict clinical improvement of acanthosis nigricans.

  Baseline to weeks 4, 8, and 12

Study Arms (1)

Patients with Acanthosis Nigricans

EXPERIMENTAL

Patients with the diagnosis of acanthosis nigricans

Drug: Sirolimus 0.2%

Interventions

Sirolimus 0.2% DRUG

sirolimus 0.2% gel

Also known as: HYFTOR

Patients with Acanthosis Nigricans

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Subjects with a malignant tumor

Sponsors & Collaborators

• Narrows Institute for Biomedical Research: lead
• Nobelpharma: collaborator

Study Sites (1)

New York Harbor VA Brooklyn Campus

Brooklyn, New York, 11209, United States

Location

Related Publications (6)

• Romo A, Benavides S. Treatment options in insulin resistance obesity-related acanthosis nigricans. Ann Pharmacother. 2008 Jul;42(7):1090-4. doi: 10.1345/aph.1K446. Epub 2008 May 20.

  PMID: 18492785 BACKGROUND

• Ding X, Bloch W, Iden S, Ruegg MA, Hall MN, Leptin M, Partridge L, Eming SA. mTORC1 and mTORC2 regulate skin morphogenesis and epidermal barrier formation. Nat Commun. 2016 Oct 27;7:13226. doi: 10.1038/ncomms13226.

  PMID: 27807348 BACKGROUND

• Dodds M, Maguiness S. Topical sirolimus therapy for epidermal nevus with features of acanthosis nigricans. Pediatr Dermatol. 2019 Jul;36(4):554-555. doi: 10.1111/pde.13833. Epub 2019 Apr 15.

  PMID: 30983034 BACKGROUND

• Treesirichod A, Thaneerat N, Kangvanskol W. A comparison of the efficacy and safety profiles of 10% salicylic acid and 10% urea creams in treating acanthosis nigricans in adolescents: a randomized double-blinded study. Arch Dermatol Res. 2023 Sep;315(7):2091-2097. doi: 10.1007/s00403-023-02605-6. Epub 2023 Mar 21.

  PMID: 36943434 BACKGROUND

• Pirgon O, Sandal G, Gokcen C, Bilgin H, Dundar B. Social anxiety, depression and self-esteem in obese adolescent girls with acanthosis nigricans. J Clin Res Pediatr Endocrinol. 2015 Mar;7(1):63-8. doi: 10.4274/jcrpe.1515.

  PMID: 25800478 BACKGROUND

• Patel NU, Roach C, Alinia H, Huang WW, Feldman SR. Current treatment options for acanthosis nigricans. Clin Cosmet Investig Dermatol. 2018 Aug 7;11:407-413. doi: 10.2147/CCID.S137527. eCollection 2018.

  PMID: 30122971 BACKGROUND

MeSH Terms

Conditions

Acanthosis Nigricans

Condition Hierarchy (Ancestors)

Melanosis; Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jared Jagdeo, MD MS

  SUNY Downstate Health Sciences University Department of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 23, 2025
• Study Start: March 1, 2025
• Primary Completion: July 8, 2025
• Study Completion: July 18, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-04

Locations

US (1)