EUCTR2017-000613-22-DE进行中（未招募）1 期
A 16 Week, Single-center, Randomized, Placebo- and Active-controlled Proof of Principle Study to Assess the Efficacy and Safety of a 5% Minoxidil Topical Gel Formulation in Male subjects with Androgenetic Alopecia
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
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
- 性别
- Male
入选标准
- •1.Men, ages 18 to 49 years with androgenetic alopecia (male pattern hair loss; MPHL) of Hamilton-Norwood patterns IIIv, IV, or V,
- •2.Willingness to have a target area of 1.9 cm diameter (~3cm2) shaved and a dot tattoo placed in the application area of the scalp four times during the study.
- •3.Willing to use the same shampoo and/or conditioner and maintain the same haircare habits and products during the study.
- •4.Willingness to maintain the same approximate hair length, hairstyle, hair color, and hair regimen throughout the study as per the protocol. No changes are permitted.
- •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 140
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Buzz” cut hairstyle, defined as hair cut to less than 2.5 cm in length.
- •2.History of hair transplants, scalp reductions or hair weaves, or desire to continue use of non-breathable wigs.
- •3.Known hypersensitivity to minoxidil, or to the ingredients in topical minoxidil preparations.
- •4.Known allergy to components used in dot tattoo.
- •5.Individuals with a past history or current evidence of hypertension (BP>140/90), hypotension (BP< 90/60), or cardiac, liver, kidney or endocrine disease of any kind, whether or not it is currently being treated with any form of medication
- •6.History of any active or untreated cancer excluding basal cell or squamous cell carcinoma of non-scalp areas within the past five years.
- •7.Presence or history of any concomitant types of hair loss including, but not limited to telogen effluvium, alopecia areata, and scarring alopecia.
- •8.Dermatologic disorders of the scalp other than male pattern hair loss (MPHL or FPHL), including eczema, fungal or bacterial infections, seborrheic dermatitis, atopic dermatitis, scarring alopecia, psoriasis, folliculitis, etc. that require chronic use of medication for control, or evidence of follicular drop-out suggestive of a destructive follicular condition.
- •9.Current or recent history (within six months) of severe dietary or weight changes or has a history of eating disorder as per Investigator’s judgement.
- •10.History of any underlying medical problems that could adversely affect hair growth, such as HIV infection, connective tissue disease, inflammatory bowel disease, uncontrolled thyroid disease, or other endocrine disorders.
- •11.Use of anti-dandruff containing ketoconazole, anti-psoriatic or anti-seborrhoeic dermatitis shampoo during the study or within one month prior to the Baseline visit.
- •12.Application of topical minoxidil preparation or any other topical Over-the counter (OTC) or prescription medication for hair re-growth to scalp for 4 weeks or more during the six months before enrollment.
- •13.Use of any topical or ocular prostaglandins (Latisse®, bimatoprost, latanoprost, or other prostaglandin ophthalmic solutions) unless taken for 4 months or greater prior to baseline.
- •14.Use of vitamin A supplements or a vitamin A dietary intake exceeding 10,000 IU/day.
- •15.Current or prior use of oral hair re-growth medications (finasteride, other 5-a-reductase inhibitors), within one year or nutraceuticals/botanicals for 3 months before enrollment.
- •16.Within the past 3 months before the Baseline visit, use of systemic cimetidine or topical ketoconazole (for more than 2 consecutive weeks).
- •17.Use of systemic 5-a-reductase inhibitors and/or anti-androgens, isotretinoin or other retinoids within 12 months prior to the Baseline visit.
- •18.Currently using, or has used systemic minoxidil for more than 4 continuous weeks, within the last 6 months prior to the Baseline visit.
- •19.Current or prior use (within the previous six months) of anti-seizure drugs, beta blockers, diuretics, or anti-androgens (e.g., spironolactone, flutamide), vasodilators (diazoxide), other than at stable doses for 6 months prior to the Baseline visit with no anticipated change during the study.
- •20.Current or prior use of immunomodulatory/immunosuppressive drugs (e.g., cyclosporin), chemotherapy/cytotoxic agents, and/or radiation therapy (to the scalp) during the study or within 12 months prior to Baseline.
- •21.Within the past 2 months prior to the Baseline visit, use of systemic or topical corti
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