CTRI/2022/09/045412尚未招募3 期
A Prospective, Multi-center, Randomized, Open-label, Parallel-group, Active-Controlled Clinical Study to Compare the Efficacy and Safety of 2% w/w Tofacitinib Topical Gel (of Macleods Pharmaceuticals Ltd) versus 5% w/v Minoxidil Topical Solution in Treatment of Adult Male Patients with Androgenetic Alopecia
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 236
- 试验地点
- 4
- 主要终点
- Percentage change in proportion of anagen hair using frontal, temporal and vertex trichoscopy in both the treatment groups (baseline to 16 weeks of treatment
研究概览
简要总结
This is a prospective, multi-center, randomized, open-label, parallel-group, active-controlled clinical study to compare the efficacy and safety of 2% w/w Tofacitinib topical gel versus 5% w/v Minoxidil topical solution in treatment of adult male patients clinically diagnosed with androgenetic alopecia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •Men aged 30 to 60 years clinically diagnosed with androgenetic alopecia (male pattern hair loss)
- •Male subjects with a Norwood-Hamilton classified as II to IV
- •Subjects willing to follow and comply with same hair-care regimen (including hair style, hair color and length) during the treatment period
- •Sexually active male subjects must agree to use a barrier form of birth control during the study
- •Willing to provide written informed consent for the trial.
排除标准
- •A subject must not fulfil any exclusion criteria to participate in the study
- •Known hypersensitivity to study treatment and its ingredients
- •Clinical diagnosis of alopecia areata or other non AGA forms of alopecia
- •Scalp hair loss on the treatment area, due to disease, injury, or medical therapy
- •Active skin disease on the scalp (such as psoriasis or seborrheic dermatitis) or a history of skin disease on the scalp that in the opinion of the investigator would interfere with the study assessments of efficacy or safety
- •Used hair weaving, hair extensions, texturizers, relaxers, occlusive wigs and non-study hair growth products or procedures within 30 days prior to screening
- •Subjects with following laboratory investigations results • Hemoglobin less than 9 mg per dL • Absolute neutrophil count (ANC) less than 1,000 per mm3 • Platelet count less than 50,000 per mL • Serum prostate-specific antigen (PSA) level of more than 2.0 ng per mL • Serum testosterone <250 ng per dL (evidence of hypogonadism) • Positive serology test results or history for HIV, hepatitis B, or hepatitis C • Serum TSH not within laboratory defined normal range • Clinically significant deranged hepatic or renal laboratory parameters • Clinically significant deranged cholesterol levels • Blood creatine phosphokinase not within laboratory defined range
- •Active unstable thyroid disease, including subjects on therapy for either hyperthyroidism or hypothyroidism unless their dose of thyroid medication has been stable for 3 months prior to screening
- •History of thrombosis, including pulmonary, deep venous and arterial or gastrointestinal perforations, or history of chronic lung disease, interstitial lung disease
- •Have received prior medications procedures within the duration specified in the protocol
- •History of current or suspected systemic or cutaneous malignancy and or lymphoproliferative disease.
- •Current herpes zoster infection
- •Evidence of tuberculosis infection or history of incompletely treated or untreated tuberculosis.
- •History of serious local infection (e.g., cellulitis, abscess) or systemic infection including but not limited to a history of treated infection (e.g.pneumonia,septicemia) within 3 months prior to screening Subjects on an antibiotic for a non-serious, acute local infection must complete the course prior to enrollment into the study.
- •Participation in any other trial within 1 month prior to screening.
- •Subjects with clinical significant 12-lead ECG findings at screening as below: • QTcF >450msec for males • Heart rate < 45 or > 100 beats/minutes (inclusive) • Rhythm disturbance other than sinus arrhythmia or ectopic supraventricular rhythm • Conduction disturbance including pulse rate more than 240 msec, pre-excitation (delta wave and pulse rate less than 120 msec), second or higher atrioventricular block • Acute or chronic signs of ischemia • Left bundle branch block • History of myocardial infarction • Any ECG abnormality which may, in the opinion of the investigator, may represent risk to the subject while participating in the study
- •Any clinically significant medical or surgical history or laboratory investigations which in the opinion of the investigator may affect efficacy analyses of study treatment or may impact subjects safety while participating in the study.
结局指标
主要结局
Percentage change in proportion of anagen hair using frontal, temporal and vertex trichoscopy in both the treatment groups (baseline to 16 weeks of treatment
时间窗: baseline to 16 weeks of treatment
次要结局
- Proportion of patients with increase in anagen hair using frontal temporal vertex trichscopy in both the treatment groups(baseline to 16 weeks of treatmentr)
研究者
研究点 (4)
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