An Open-Label Study to Evaluate DPCP Ointment for the Treatment of Alopecia Areata
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Number of Participants With Alopecia Areata That Have Increased Hair Growth as Assessed by SALT Score
研究概览
简要总结
This is an open labeled study to determine the response and characteristics, safety and efficacy, of the proprietary DPCP ointment composition as a topical immunotherapeutic agent for the treatment of extensive alopecia areata.
详细描述
This is an open labeled study to determine the response and characteristics, safety and efficacy, of the proprietary DPCP ointment composition as a topical immunotherapeutic agent for the treatment of extensive alopecia areata.
Up to 10 subjects with 76% to 99% scalp hair loss that, in the opinion of the PI, are eligible for treatment with DPCP will be enrolled. Patients will be recruited from the new and current patient population seen for alopecia areata through the University of Minnesota Medical Center Dermatology Clinic as well as through partnership with the National Alopecia Areata Foundation Clinical Trials Network, and various media outlets.
The products to be evaluated are as follows:
- 0.05 mL of 0.4% DPCP (sensitization dose) applied topically to the inner aspect of the upper right arm. ("Sensitization and Baseline Sample Collection Visit")
- 0.05 mL four dose concentration matrix of DPCP ointment (0.1, 0.05, 0.01, 0.005%) prepared through dilutions in a non-volatile vehicle (applied to the inner aspect of the left upper thigh). ("Dose Determination Visit"; 10-14 days after the Sensitization Visit)If sensitization is not attained after 10 to 14 days, the procedure will be repeated once.
The subject will return 2 days after the Dose Determination Visit, so the PI or co-PI can assess the dose concentration matrix. The weakest strength concentration that caused a minimal reaction will be used throughout the study. 0.75-1 g of the treatment drug will be aThe treatment drug will be applied by the PI, a trained study coordinator, or a staff member of the Clinical Research Unit at the University of Minnesota. Eligible subjects may begin receiving the study drug immediately after enrollment and screening.
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
- •Subject has clinical diagnosis of extensive alopecia areata (76%-99% involvement as determined by SALT score, Appendix B, Part I).
- •Written informed consent and HIPAA authorization have been obtained.
- •Subject is > 18 to years of age.
- •Female subjects of childbearing potential have a negative pregnancy test and agree to use an acceptable, highly effective method of birth control (i.e., failure rate of less than 1% per year) to prevent pregnancy.
- •Subject agrees to comply with protocol requirements and attend all required study visits and is considered to be a good study subject.
- •Subject meets concomitant medication washout requirements
排除标准
- •Subject has <76 or greater than 99% hair loss.
- •Subject is pregnant or lactating.
- •Subject has current controlled or uncontrolled bacterial, viral (with the exception of herpes simplex), fungal, atypical, or opportunistic infection(s).
- •Subject has a history of substance abuse within the past five years.
- •Immunosuppression (history of transplantation, chemotherapy, splenectomy, HIV).
- •Administration of systemic treatment (e.g., Imuran, biologics) that have an immunomodulatory mechanism of action in the preceding 3 months.
- •Previous treatment with DPCP.
- •Application of topical immunomodulating agent in the preceding 6 weeks.
- •Application of topical or intralesional corticosteroids within the past 6 weeks.
- •Systemic (oral, inhaled, or intravenous) administration of corticosteroid or other systemic treatment (i.e., prednisone) with an immunosuppressive mechanism of action within the past 3 months.
- •Use of light treatments (e.g., PUVA, narrow band UVB) in the preceding 6 weeks.
- •Use of Anthralin in preceding 6 weeks.
- •Use of minoxidil, topical or oral, in the preceding 4 weeks.
- •Subject is currently or has undergone systemic therapy for malignancy within the past five years except for adequately treated Squamous Cell Carcinoma (SCC) or Basal Cell Carcinoma (BCC) of the skin.
- •Clinical evidence of secondary skin infection (i.e., folliculitis).
- •Participation in other therapeutic investigational clinical trials within 4 weeks of enrollment.
- •Evidence of anemia, thyroid disease, sarcoidosis or other medical condition that could be adversely affected by participating in the study.
- •Subject has any medical condition that, in the judgment of the Investigator, would jeopardize the subject's safety following exposure to the administered medications.
研究组 & 干预措施
Diphenylcyclopropenone (DPCP) Ointment
All subjects will be administered a sensitization dose of 0.05 mL 0.4% DPCP ointment formulation topically in the inner aspect of the upper right arm at Day -16, and 0.05 mL of four concentrations (0.1, .05, 0.01, 0.005%), prepared through dilutions in the ointment vehicle, topically on the inner aspect of the left thigh at Day -2. The weakest strength that may cause a minimal reaction (DTH skin reaction score of 1+) after two days will be chosen, and 0.75-1 g of that concentration will be applied to the scalp starting at Week 1 and administered subsequently twice a week for 18 weeks
干预措施: Diphenylcyclopropenone (DPCP) Ointment (Drug)
结局指标
主要结局
Number of Participants With Alopecia Areata That Have Increased Hair Growth as Assessed by SALT Score
时间窗: 18 weeks
Efficacy will be assessed as follows; a. Severity of Alopecia tool (SALT) score: Percentage of hair loss on the scalp will be determined using he SALT score, a global alopecia areata severity score based on scalp hair loss. The SALT score is calculated by visually examining four descrete areas of the scalp, measuring the percentage of terminal hair loss in each area. b. Scalp Photograhpy. c. Hair pull tests (positive or negative)
次要结局
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](18 weeks)
- Determine the Best Starting Dose Range for Future Studies(18 weeks)