EUCTR2011-000379-15-DE进行中（未招募）不适用
A Multicenter, Randomized, Double-blind, Parallel-group Study to Evaluate the Safety and Efficacy of Bimatoprost Solution 0.03%, 0.1%, and 0.3% Compared with Vehicle in Men with Androgenic Alopecia with an Open-label Active Comparator (Minoxidil 5%) Group
Allergan Ltd.0 个研究点目标入组 300 人开始时间: 2011年4月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
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
- •The following are requirements for entry into the study:
- •1. Males 18 to 49 years of age with mild to moderate AGA of the vertex area of the scalp (modified Norwood Hamilton scale classification of IIIv, IV, or V) who report scalp hair growth/coverageloss ongoing for at least 1 year
- •2. Written informed consent has been obtained
- •3. Written documentation has been obtained in accordance with the relevant country and
- •local privacy requirements, where applicable (eg, Written Authorization for Use and
- •Release of Health and Research Study Information [US sites] and written Data
- •Protection consent [EU sites])
- •4. Standardized global photographs of the scalp at the screening visit of acceptable quality for assessment, as verified by Canfield Scientific, Inc. (Canfield)
- •5. Ability to follow study instructions and willingness to complete all required procedures and visits, including micro-dot tattoo and macro photography procedures
- •6. Hair length in non-balding areas = 2 cm (3/4 inch) around the vertex region of scalp and willing to maintain the same hair style, approximate length, and hair color throughout the duration of the study
- •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 300
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The following are criteria for exclusion from participating in the study:
- •1. An uncontrolled systemic disease
- •2. Subjects with a history of significant cardiovascular disease, family history of long QT syndrome, or a clinically significant ECG abnormality at the screening visit.
- •3. History or current evidence of drug or alcohol abuse within 12 months prior to study entry
- •4. Subjects known to be HIV positive
- •5. Subjects with sensitive, irritated, or abraded scalp area
- •6. Subjects with global scalp hair thinning, including occipital areas
- •7. Subjects with any known scarring, disease, infection, or abnormality of the scalp or hair shaft or systemic disease that could prevent hair growth or produce abnormal hair (for example, seborrheic dermatitis, psoriatic dermatitis, alopecia areata, cicatricial alopecia, uncontrolled hyperthyroidism/hypothyroidism, tinea infections, genetic disorders)
- •8. Subjects who have received hair transplants or had scalp reductions
- •9. Concurrent use of hair weavings, hair extensions, or wigs or within 3 months prior to study entry
- •10. Concurrent use of topical steroidal or nonsteroidal anti-inflammatory drugs applied to the scalp, or within 4 weeks prior to study entry; inhaled glucocorticoids are allowed
- •11. Concurrent treatment or within 6 months prior to study entry of any of the following:
- •a. Prostaglandins or prostamides
- •b. Minoxidil (oral or topical)
- •c. Drugs with anti-androgenic properties (for example, cyproterone acetate, spironolactone, flutamide, bicalutamide, cimetidine, oral ketoconazole)
- •d. Topical or oral estrogen, progesterone, tamoxifen
- •12. Concurrent systemic treatment that may affect hair growth (for example, 5 alpha reductase inhibitors such as finasteride and dutasteride, cytotoxic agents, cyclosporine, diazoxide, anabolic steroids) or within 12 months prior to study entry
- •13. Known allergy or sensitivity to the study medication or its components
- •14. Known allergy, sensitivity, or contraindication to minoxidil
- •15. Known allergy or sensitivity to tattoo ink
- •16. Current enrollment in an investigational drug or device study or participation in such a study within 30 days prior to study entry
- •17. Subject has a condition or is in a situation which, in the investigator’s opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject’s participation in the study
研究者
相似试验
进行中（未招募）
不适用
A clinical trial to study the safety and effectiveness of three different strengths (0.03%, 0.1% and 0.3%) bimatoprost solution compared to a solution containing no active ingredient (placebo) and an already licenced product (minoxidil 2%) in the treatment of female pattern hair loss in women.Female pattern hair lossMedDRA version: 14.0Level: LLTClassification code 10016407Term: Female pattern hair thinningSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2011-000380-27-DEAllergan Ltd.300
进行中（未招募）
1 期
A Study of Benralizumab in Patients with Eosinophilic EsophagitisEosinophilic Esophagitis (EoE)MedDRA version: 20.1Level: LLTClassification code 10064220Term: Eosinophilic esophagitisSystem Organ Class: 100000004856EUCTR2019-002871-32-PLAstraZeneca AB170
进行中（未招募）
1 期
A Proof-of-concept Study of the Efficacy and Safety of Nipocalimabin Participants with Active Rheumatoid Arthritis.EUCTR2021-000510-42-ESJanssen-Cilag International NV50
进行中（未招募）
1 期
A Study of Benralizumab in Patients with Eosinophilic EsophagitisEosinophilic Esophagitis (EoE)MedDRA version: 20.1Level: LLTClassification code 10064220Term: Eosinophilic esophagitisSystem Organ Class: 100000004856EUCTR2019-002871-32-NLAstraZeneca AB170
进行中（未招募）
1 期
A Study of Benralizumab in Patients with Eosinophilic EsophagitisEUCTR2019-002871-32-ITASTRAZENECA AB210