EUCTR2011-000380-27-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 Women with Female Pattern Hair Loss with an Open-label Active Comparator (Minoxidil 2%) Group
Allergan Ltd.0 个研究点目标入组 300 人开始时间: 2011年4月5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
- Female
入选标准
- •The following are requirements for entry into the study:
- •1. Females 18 to 59years of age with mild to moderate FPHL (Ludwig scale classification of II) who report hair loss 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. Subjects of childbearing potential must have a negative urine pregnancy test at day 1 prior to receiving study medication. A woman is considered NOT to be of childbearing potential if she either is post menopausal with at least 12 consecutive months of amenorrhea or has no uterus.
- •6. Subjects of childbearing potential must be willing to use a reliable method of contraception, with stable use of that contraceptive for 6 months prior to study entry and willing to maintain the same throughout the study
- •7. Ability to follow study instructions and willingness to complete all required procedures and visits, including micro-dot tattoo and macro photography procedures
- •8. Willing to maintain the same hair style, approximate length, and hair color throughout 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 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, diffuse telogen effluvium, androgen hair loss/hyper-androgenemia, tinea infections, genetic disorders)
- •7. Subjects who have received hair transplants or had scalp reductions
- •8. Concurrent use of hair weavings, hair extensions, or nonbreathable wigs or within 3 months prior to study entry
- •9. 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
- •10. 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 [except when used as stable contraceptive as described in the study inclusion criteria], spironolactone, flutamide, bicalutamide, cimetidine, oral ketoconazole)
- •d. Topical or oral estrogen or progesterone except when used as a continuous and stable method of contraception or hormone replacement therapy without change to type, dose, or regimen for 6 months prior to study entry or tamoxifen
- •11. 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
- •12. Known allergy or sensitivity to the study medication or its components
- •13. Known allergy, sensitivity, or contraindication to minoxidil
- •14. Known allergy or sensitivity to tattoo ink
- •15. Females who are pregnant, nursing, or planning a pregnancy during the study or who are of childbearing potential and not using a reliable method of contraception
- •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
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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 5%) in the treatment of male-pattern baldness (androgenic alopecia).Androgenic alopecia in menMedDRA version: 14.0Level: LLTClassification code 10068558Term: Androgenic alopeciaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2011-000379-15-DEAllergan Ltd.300