A Phase 2 interventional study of Sirolimus 0.2% in Acanthosis Nigricans, sponsored by Narrows Institute for Biomedical Research. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-28.
Sponsored by Narrows Institute for Biomedical Research · Phase 2, Interventional, and Treatment
The purpose of this study is to demonstrate the safety and efficacy of Sirolimus 0.2% topical gel for patients with Acanthosis Nigricans
Narrows Institute for Biomedical Research is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with the diagnosis of acanthosis nigricans
Drug: Sirolimus 0.2%
sirolimus 0.2% gel
Also known as: HYFTOR
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.
Time frame: From enrollment to end of treatment at 12 weeks
Improvement in hyperpigmentation and skin texture in acanthosis nigricans lesions
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.
Time frame: Baseline to weeks 4, 8, and 12
Improvement in the Investigators Global Evaluation (IGE) scale and Patient Global Evaluation (PGE) scale
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."
Time frame: Baseline to weeks 4, 8, and 12
Improvement in the Dermatology Quality of Life (DLQI) scale
The DLQI ranges from 0 to 30 with higher scores denoting worse quality of life.
Time frame: From enrollment to end of treatment at 12 weeks
Assessment of patient satisfaction using the Treatment Satisfaction Questionnaire for Medication (TSQM)
Assessment of patient satisfaction using the treatment satisfaction questionnaire for medication
Time frame: Week 12
Digital photography with a TwinFlash RL Clinical Camera to depict clinical improvement of acanthosis nigricans.
Digital photography with a TwinFlash RL Clinical Camera to depict clinical improvement of AN
Time frame: Baseline to weeks 4, 8, and 12
Plan to share: Undecided — undecided whether IPD will be shared.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sirolimus
Acanthosis Nigricans
Narrows Institute for Biomedical Research