EUCTR2017-003809-17-DE进行中（未招募）1 期
A randomised, double-blind, placebo-controlled phase 2 trial of FOL-005 to investigate efficacy on hair growth on scalp skin in healthy volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Follicum AB
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1.Healthy male, aged 18-55 years
- •2.Androgenetic alopecia (AGA)) – Norwood/Hamilton grade 3V to 4/4a
- •3.Caucasian, skin type I – IV according to Fitzpatrick’s classification
- •4.Willing to have treatment areas shaved for TrichoScan® measurement marked with small semi-permanent dot tattoos
- •5.Willing to maintain the same hygiene products and skin cleansing habits during the trial period.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Damaged skin in or around test sites including sunburn, uneven skin tones, tattoos, scars or other disfiguration of the test sites risking interfering with investigational evaluations
- •2.Any dermatological disorders of the scalp or skin pathology which might interfere with the application of IMP or examination method
- •3.History of active hair loss due to alopecia areata, scarring alopecia, diffuse telogen effluvium or conditions other than androgenetic alopecia
- •4.History of any acute (e.g. acute infections) or chronic illness (e.g. psoriasis, atopic dermatitis, porphyria) or known skin cancer that in the opinion of the investigators might confound the results of the trial
- •5.Immunological disorders such as alopecia areata, and systemic lupus erythematosus and other systemic known autoimmune disorders
- •6.Diabetes mellitus
- •7.Coagulation deficiencies
- •8.Known or suspected allergy or sensitization to cosmetic hair dyes or hypersensitivity to ingredients of the IMP or tattoo ink.
- •9.Any topical or systemic treatments with agents, known or suspected to affect hair growth
- •10.Use of or planned use of any shampoo with expected medicinal effect on the scalp (e.g. but not limited to antifungal or anti-dandruff shampoo, shampoo containing urea, caffeine or acetylsalicylic acid, etc.) during the course of the trial
- •11.Elevated values for vital signs:
- •blood pressure: systolic above 160 mmHg, diastolic above 95 mmHg
- •heart rate: above 100 beats/min.
- •12.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, regular intake of acetylsalicylic acid)
- •13.Current or within 3 months prior to first dosing use of anti-inflammatory medication (ibuprofen, paracetamol is permitted), corticosteroids (nose drops, eye drops and/or inhalers are permitted) or immunosuppressive drugs taken for more than 2 consecutive weeks
- •14.Current or within the last 6 months history of severe dietary or weight changes
- •15.Hair transplantation at any time
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