NCT06940895已完成2 期
Evaluating the Safety and Efficacy of Topical Sirolimus 0.2% to Treat Acanthosis Nigricans
Narrows Institute for Biomedical Research1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2025年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Improvement in hyperpigmentation in acanthosis nigricans lesions
研究概览
简要总结
The purpose of this study is to demonstrate the safety and efficacy of Sirolimus 0.2% topical gel for patients with Acanthosis Nigricans
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Patients with Acanthosis Nigricans
Experimental
Patients with the diagnosis of acanthosis nigricans
干预措施: Sirolimus 0.2% (Drug)
结局指标
主要结局
Improvement in hyperpigmentation in acanthosis nigricans lesions
时间窗: 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.
次要结局
- Assessment of patient satisfaction using the Treatment Satisfaction Questionnaire for Medication (TSQM)(Week 12)
- Improvement in hyperpigmentation and skin texture in acanthosis nigricans lesions(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)
- Improvement in the Investigators Global Evaluation (IGE) scale and Patient Global Evaluation (PGE) scale(Baseline to weeks 4, 8, and 12)
- Digital photography with a TwinFlash RL Clinical Camera to depict clinical improvement of acanthosis nigricans.(Baseline to weeks 4, 8, and 12)
研究者
研究点 (1)
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