A Randomised, Double-blind, Placebo-controlled Trial of FOL-005 to Investigate Clinical Safety and Effect on Hair Growth in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Follicum AB
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Safety and tolerability by assessing the number and severity of adverse events after intradermal applications of FOL-005 in healthy subjects
研究概览
简要总结
A study to investigate clinical safety and effect on hair growth of FOL-005 in healthy volunteers. The study is divided in two parts, a single ascending dose (SAD) part and a multiple dose (MD) part.
详细描述
SAD part:
A total of 3 weeks dosing, the two lowest concentrations in week 1, dose 3 at week 2 and finally dose 4 at week 3.
MD part:
In total 12 weeks of dosing where group A will be dosed twice weekly and group B three times weekly
Each injection will be administered into one of five of the six randomized areas (10 cm apart, left and right side) from the subject's defined investigational skin areas. One area will be completely untreated.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male, aged 18-45 years
- •Clinically visible terminal hair growth on thighs
排除标准
- •Damaged skin in or around test sites
- •History of any acute (e.g. acute infections) or chronic illness or known skin cancer that might confound the results of the trial
- •History or clinical signs of keloids or hypertrophic scars
- •Immunological disorders such as alopecia areata, and systemic lupus erythematosus
- •Current or within 2 weeks prior to first dosing use of vasodilating drugs (e.g. Pentoxifyllin, nitroglycerine) or anticoagulating drugs (e.g. heparine, cumarines, new oral anticoagulants)
- •Current or within 3 months prior to first dosing use of anti-inflammatory medication, corticosteroids or immunosuppressive drugs taken for more than 2 consecutive weeks
- •Current or within 3 months prior to first dosing use of medication with hair growth modifying properties like minoxidil, diazoxid, cyclosporine, antiandrogens
- •Current or within 12 months prior to first dosing intake of anabolics or 5-alpha reductase inhibitors
- •Current or within one week prior to first dosing use of any topical drugs on the legs
研究组 & 干预措施
Placebo
Intradermal injection of 50 μl solution. One application in SAD part for each dosing occasion. 2 or 3 times weekly for 3 month in MD part.
干预措施: Placebo (Other)
FOL-005: Solution 1
Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.
干预措施: FOL-005 (Drug)
FOL-005: Solution 2
Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.
干预措施: FOL-005 (Drug)
FOL-005: Solution 3
Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.
干预措施: FOL-005 (Drug)
FOL-005: Solution 4
Intradermal injection of 50 μl solution. One application in SAD part. 2 or 3 times weekly for 3 month in MD part.
干预措施: FOL-005 (Drug)
结局指标
主要结局
Safety and tolerability by assessing the number and severity of adverse events after intradermal applications of FOL-005 in healthy subjects
时间窗: 3 months
次要结局
- Effect of FOL-005, as compared to placebo, with respect to number of hairs/cm2(3 months)
- Effect of FOL-005, as compared to placebo, with respect to proportion of telogen hairs(3 months)
- Effect of FOL-005, as compared to placebo, with respect to proportion of anagen hairs(3 months)