Pilot Study of Novel Topical Drug (Photocil) for the Treatment of Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Number of Pruritus Events in Last 30 Days
研究概览
简要总结
Photocil is a topical drug (cream) that selectively delivers Narrow Band - Ultraviolet B (NB-UVB) therapy when exposed to sunlight. Photocil is intended to help protect users from non-therapeutic Ultraviolet B (UVB) radiation while selectively passing wavelengths of light in the NB-UVB range with peak transmission of 308nm. The aim of the study is to assess the safety and efficacy of Photocil in the treatment of atopic dermatitis.
详细描述
NB-UVB phototherapy is a common treatment for patients with atopic dermatitis, and has been reported to be safe and effective in numerous clinical trials. Clinical trials have reported achievement of Atopic Dermatitis Area Severity Index (ADASI)-75 in 50-70% of patients after 4-6 weeks of NB-UVB treatment.
Many drawbacks limit patients compliance, access, and acceptance of traditional NB-UVB phototherapy. The strict treatment regimen (2-3 sessions per week for an average of 12 weeks or more) performed at a specialized phototherapy clinic combined with high cost and low or no reimbursement make compliance and access a major drawback.
In order to address the drawbacks of phototherapy, we developed a novel topical cream - Photocil - that selectively delivers NB-UVB therapy when exposed to sunlight. When used with natural sunlight, Photocil provides a convenient alternative to traditional clinic based phototherapy; thus, has the potential to dramatically increase patient compliance and treatment outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Diagnosed with atopic dermatitis confirmed by a dermatologist
- •Atopic dermatitis lesions affecting at a minimum 5% of the facial, legs, or arms surface area
- •Age: 18 to 65
- •Participants able to give informed consent
排除标准
- •Subject did not respond to prior phototherapy treatment
- •Subject completed phototherapy for same lesion(s) in last 6 months
- •Subject has previous history of skin cancer
- •Subject has previous history of photosensitivity
- •Subject has a history of herpes (HSV I or II) outbreaks
- •Subject has previous history of autoimmune disease may be excluded at investigator's discretion
- •Subject is currently taking of immunosuppressive or photosensitizing drugs
- •Subject plans to use antibiotics, anti-fungal, calcineurin inhibitors or other drugs that may cause photosensitivity during the study period. These patients may be excluded at investigator's discretion
- •Subject is pregnant or lactating women
研究组 & 干预措施
Photocil for Atopic Dermatitis
Active Drug - Photocil for Atopic Dermatitis
干预措施: Photocil for Atopic Dermatitis (Drug)
Placebo - Sunscreen (SPF 2)
Placebo - Sunscreen (SPF 2)
干预措施: Placebo - Sunscreen (SPF 2) (Other)
结局指标
主要结局
Number of Pruritus Events in Last 30 Days
时间窗: 30 days from baseline
次要结局
未报告次要终点