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
- 2 期
- 状态
- 已完成
- 发起方
- Follicum AB
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Scalp Hair Density
研究概览
简要总结
The trial was a multicentre, randomised, double-blind, placebo controlled phase 2 trial.
60 healthy bald male subjects diagnosed with alopecia, who are between 18 and 55 years old and provide written informed consent were eligible for inclusion.
The trial period consisted of a screening period of up to 3 weeks followed by 12 weeks of dosing, three times per week. Each subject received two doses of the five trial treatment doses (placebo, 0.00625, 0.025, 0.050, and 0.100 μg respectively). The doses were given as intradermal injections. On each volunteer, two treatment areas were placed on the head and the two selected doses were allocated to the respective treatment areas according to the randomisation scheme. The treatment areas were selected on the border between the bald surface and the surface with hair.
The effect on hair growth was measured by the use of Trichoscan imaging and measuring method at week 8 and 12. A baseline measaure was taken at day 0.
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male, aged 18-55 years
- •Androgenetic alopecia (AGA)) - Norwood/Hamilton grade 3V to 4/4a
- •Caucasian, skin type I - IV according to Fitzpatrick's classification
排除标准
- •Any dermatological disorders of the scalp which might interfere with the application of Investigational Medical Product or examination method, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis or scalp atrophy
- •Any skin pathology (e.g. scar, nevus) or general condition (e.g. uncontrolled thyroid diseases) that in the investigator's opinion can interfere with the evaluation of the treatment areas or requires topical or systemic therapy
- •History of active hair loss due to alopecia areata, scarring alopecia, diffuse telogen effluvium or conditions other than androgenetic alopecia
- •Immunological disorders such as alopecia areata, and systemic lupus erythematosus and other systemic known autoimmune disorders
- •Diabetes mellitus
- •Coagulation deficiencies
- •Topical treatments for hair growth (minoxidil, anti-androgens or other agents known to affect hair growth) in the last 6 months
- •Topical treatments of the scalp including corticosteroids, tacrolimus, retinoids in the last 2 months or other treatments that may affect hair growth
- •Platelet rich plasma (PRP) treatment on scalp during the last 12 months
- •Systemic therapy using retinoids, cyclosporine within the last 3 months
- •Systemic treatment with beta blockers or corticosteroids, scalp procedures e.g. surgery, laser, light, micro-needling within the last 6 months
- •Finasteride (e.g. Propecia®) or Dutasteride intake in the last 12 months, or any systemic hair therapy medication in the last 12 months
- •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
- •History or clinical signs of keloids or hypertrophic scars
- •Positive HIV-Antibody, HBs-Antigen or HCV-Antibody-Test at screening
- •Current or within 2 weeks prior to first dosing use of vasodilating drugs (e.g. Pentoxifylline, nitroglycerine) or anticoagulating drugs (e.g. heparins, cumarins, new oral anticoagulants, regular intake of acetylsalicylic acid)
- •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
- •Hair transplantation at any time
研究组 & 干预措施
0.00625 μg FOL-005
50 μl solution (a total dose of 0.00625 μg FOL-005) injected intradermally three times per week for 12 weeks.
干预措施: FOL-005 (Drug)
0.025 μg FOL-005
50 μl solution (a total dose of 0.025 μg FOL-005) injected intradermally three times per week for 12 weeks.
干预措施: FOL-005 (Drug)
0.050 μg FOL-005
50 μl solution (a total dose of 0.050 μg FOL-005) injected intradermally three times per week for 12 weeks.
干预措施: FOL-005 (Drug)
0.100 μg FOL-005
50 μl solution (a total dose of 0.100 μg FOL-005) injected intradermally three times per week for 12 weeks.
干预措施: FOL-005 (Drug)
Placebo
50 μl solution (placebo) injected intradermally three times per week for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Scalp Hair Density
时间窗: 12 weeks
Change from baseline of total hair density (No. of hairs per cm"2") on the scalp
次要结局
- Anagen Hair Density(From baseline to after 12 weeks treatment)
- Proportion of Anagen Hairs (%)(From baseline to after 12 weeks treatment)
- Change in Proportion of Telogen Hairs (%)(From baseline to after 12 weeks treatment)
- Change in Telogen Hair Density(From baseline to after 12 weeks treatment)