NCT02636244Unknown2 期
A Multi-Center, Open-Label Phase 2 Study to Evaluate the Safety and Efficacy of SHAPE Gel, a Histone Deacetylase Inhibitor, in Patients With Alopecia Areata
TetraLogic Pharmaceuticals0 个研究点目标入组 40 人开始时间: 2017年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 主要终点
- Response evaluated using modified Severity of Alopecia Tool (mSALT)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of SHAPE Gel applied topically to adult patients with alopecia areata of the scalp.
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
- •Diagnosis of scalp alopecia areata and scalp hair loss due to alopecia areata for a minimum of six months and a maximum of two years.
- •Patients taking thyroid medication or hormonal therapy must be on a stable dose for 6 months and maintain such throughout the study.
- •Willingness to maintain same hair style, including shampoo and hair dye, throughout the study period.
- •Willingness to have a small micro dot tattoo placed to allow for photographic analysis of treatment and application of study medication.
排除标准
- •History of systemic or cutaneous malignancy and/or lymphoproliferative disease, other than patients with: up to 3 basal cell carcinoma; up to three well differentiated cutaneous squamous cell carcinoma; and/or cervical intraepithelial neoplasm (CIN), treated successfully with no evidence of disease, and treated for greater than 6 months prior to study entry.
- •Current actinic keratosis on the scalp and/or face
- •Nevi or cutaneous lesions thought suspicious for malignancy.
- •History of or current gastrointestinal, pulmonary, cardiovascular, genitourinary or hematological disease, CNS disorders, infectious disease or coagulation disorders that would preclude participation in and completion of study assessments.
- •Positive for hepatitis B surface antigen, HIV or hepatitis C.
- •Co-existent androgenetic alopecia: in males: Norwood-Hamilton stage IV, V or VI; in females: Ludwig stage II or III.
- •Unwillingness to discontinue use of non-breathable wigs, weaves or shaving of scalp throughout course of study.
研究组 & 干预措施
SHAPE Gel
Experimental
1% SHAPE Gel applied twice daily for 12 weeks.
干预措施: SHAPE Gel (Drug)
结局指标
主要结局
Response evaluated using modified Severity of Alopecia Tool (mSALT)
时间窗: Every 4 weeks; up to 24 weeks
Severity of Alopecia Tool (SALT) estimates percent scalp hair loss and percent regrowth of hair following intervention
次要结局
- Effects on quality of life using Subject Assessment of Hair Loss (SAHL)(Every 4 weeks; up to 24 weeks)
- Effects on quality of life using Alopecia Areata Symptom Impact Scale (AASIS)(Every 4 weeks; up to 24 weeks)
- Effects on quality of life using the Skindex-16(Every 4 weeks; up to 24 weeks)
- Incidence of Treatment-Emergent Adverse Events (safety and tolerability)(Every 4 weeks, up to 12 weeks)
研究者
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