A Prospective, Phase 2a Study to Evaluate the Effectiveness and Safety of DPCP Ointment (Samcyprone™) on the Clearance of Verruca Vulgaris (Common Warts) in Subjects Ages 18 - 65 Years
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 83
- 试验地点
- 4
- 主要终点
- The effectiveness of Sensitizing DPCP Ointment in eliciting a sensitization response in healthy subjects with common warts by assessing the immunotherapeutic response
研究概览
简要总结
Warts are benign epidermal tumors caused by human papillomaviruses (HPVs). The active pharmaceutical ingredient DPCP has been used for many years as a compounded formulation in acetone for the treatment of warts, alopecia areata and more recently, cutaneous metastatic melanoma lesions. An improved topical ointment formulation of DPCP called Samcyprone™ will be evaluated for the treatment of common warts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects between the ages of 18 and 65 years of age, inclusive
- •Subjects presenting with at least one verruca vulgaris (common cutaneous, plantar, and periungual) warts for at least 4 weeks, but no more than 3 years
- •Subject's common warts for treatment must measure between 3 and 20 mm and be located on hands, feet, limbs and/or trunk. A maximum of four (4) cutaneous single warts or one (1) area of clustered or adjacent warts up to 80 mm will be treated
排除标准
- •Genital warts may not be selected as target warts
- •Subjects that are immuno-compromised
- •Presence of systemic or localized diseases, conditions, or medications that could interfere with assessment of safety and efficacy or that compromise immune function
研究组 & 干预措施
Sensitization Phase
Up to two doses of Sensitizing DPCP Ointment will be applied and subjects who exhibit a sensitization response will enter the Treatment Phase. Pharmacokinetics (PK) of Sensitizing DPCP Ointment will be measured in a subset of subjects. For PK, blood will be collected prior to application of the Sensitizing DPCP Ointment and again at 1, 2, and 24 hours after application.
干预措施: Sensitizing DPCP Ointment (Drug)
Treatment Phase
In the Treatment Phase, subjects will receive doses of Treatment DPCP Ointment weekly for 10 weeks. Subjects who at the end of the Treatment Phase have exhibited partial clearance of warts may be given the option to continue with an additional 10 weekly treatments.
干预措施: Treatment DPCP Ointment (Drug)
结局指标
主要结局
The effectiveness of Sensitizing DPCP Ointment in eliciting a sensitization response in healthy subjects with common warts by assessing the immunotherapeutic response
时间窗: 4 to 6 weeks
Assessment of immunotherapeutic response per subject will include gauging the Delayed-Type Hypersensitivity (DTH) response after application sensitizing DPCP ointment. A minimum +2 DTH response will be considered a positive sensitization result
The effectiveness of Treatment DPCP Ointment will be measured by the Investigator's Global Assessment Score (IGAS)
时间窗: 11 to 20 weeks
The Investigator's Global Assessment Score (IGAS) is a 4-point scale that will be used to evaluate wart clearance for all treated warts separately. Results will further be utilized to determine overall clearance of treated warts in total. Wart lesion surface area will be measured and used to assist in determining IGAS Score.
次要结局
- The safety and tolerability of a treatment regimen for common warts consisting of a sensitization dose with Sensitizing DPCP Ointment and ten weekly treatments with Treatment DPCP Ointment, assessed by reported adverse events(30 weeks)
- To evaluate the concentration corresponding to Tlast (Clast) by pharmacokinetics (PK) of DPCP in blood after topical administration of the Sensitizing DPCP Ointment in a subset of subjects(2 days)
- To evaluate the time to Cmax by pharmacokinetics (PK) of DPCP in blood after topical administration of the Sensitizing DPCP Ointment in a subset of subjects(2 days)
- To evaluate the time to last measurable concentration (Tlast) by pharmacokinetics (PK) of DPCP in blood after topical administration of the Sensitizing DPCP Ointment in a subset of subjects(2 days)
- To evaluate the area under the concentration curve (AUC) by pharmacokinetics (PK) of DPCP in blood after topical administration of the Sensitizing DPCP Ointment in a subset of subjects(2 days)
- To evaluate Cmax by pharmacokinetics (PK) of DPCP in blood after topical administration of the Sensitizing DPCP Ointment in a subset of subjects(2 days)