Evaluating the Safety and Efficacy of Topical Sirolimus 0.2% to Treat Acanthosis Nigricans
- Registration Number
- NCT06940895
- Lead Sponsor
- Narrows Institute for Biomedical Research
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5
- 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 mammalian target of rapamycin(mTOR) inhibitory action within 12 months prior to the first visit.
- Subjects with a malignant tumor
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients with Acanthosis Nigricans Sirolimus 0.2% Patients with the diagnosis of acanthosis nigricans
- Primary Outcome Measures
Name Time Method Improvement in hyperpigmentation in acanthosis nigricans lesions 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.
- Secondary Outcome Measures
Name Time Method Assessment of patient satisfaction using the Treatment Satisfaction Questionnaire for Medication (TSQM) Week 12 Assessment of patient satisfaction using the treatment satisfaction questionnaire for medication
Improvement in hyperpigmentation and skin texture in acanthosis nigricans lesions 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.
Improvement in the Dermatology Quality of Life (DLQI) scale From enrollment to end of treatment at 12 weeks The DLQI ranges from 0 to 30 with higher scores denoting worse quality of life.
Improvement in the Investigators Global Evaluation (IGE) scale and Patient Global Evaluation (PGE) scale 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."
Digital photography with a TwinFlash RL Clinical Camera to depict clinical improvement of acanthosis nigricans. Baseline to weeks 4, 8, and 12 Digital photography with a TwinFlash RL Clinical Camera to depict clinical improvement of AN
Trial Locations
- Locations (1)
New York Harbor VA Brooklyn Campus
šŗšøBrooklyn, New York, United States