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
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Men aged 30 to 60 years clinically diagnosed with androgenetic alopecia (male pattern hair loss)
- •2. Male subjects with a Norwood-Hamilton classified as II to IV
- •3. Subjects willing to follow and comply with same hair-care regimen (including hair style, hair color and length) during the treatment period
- •4. Sexually active male subjects must agree to use a barrier form of birth control during the study
- •5. 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
- •1. Known hypersensitivity to study treatment and its ingredients
- •2. Clinical diagnosis of alopecia areata or other non AGA forms of alopecia
- •3. Scalp hair loss on the treatment area, due to disease, injury, or medical therapy
- •4. 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
- •5. Used hair weaving, hair extensions, texturizers, relaxers, occlusive wigs and non-study hair growth products or procedures within 30 days prior to screening
- •6. Subjects with following laboratory investigations results
- •Ã¢â?¬Â¢ Hemoglobin less than 9 mg per dL
- •Ã¢â?¬Â¢ Absolute neutrophil count (ANC) less than 1,000 per mm3
- •Ã¢â?¬Â¢ Platelet count less than 50,000 per mL
- •Ã¢â?¬Â¢ Serum prostate-specific antigen (PSA) level of more than 2.0 ng per mL
- •Ã¢â?¬Â¢ Serum testosterone <250 ng per dL (evidence of hypogonadism)
- •Ã¢â?¬Â¢ Positive serology test results or history for HIV, hepatitis B, or hepatitis C
- •Ã¢â?¬Â¢ Serum TSH not within laboratory defined normal range
- •Ã¢â?¬Â¢ Clinically significant deranged hepatic or renal laboratory parameters
- •Ã¢â?¬Â¢ Clinically significant deranged cholesterol levels
- •Ã¢â?¬Â¢ Blood creatine phosphokinase not within laboratory defined range
- •7. 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
- •8. History of thrombosis, including pulmonary, deep venous and arterial or gastrointestinal perforations, or history of chronic lung disease, interstitial lung disease
- •9. Have received prior medications procedures within the duration specified in the protocol
- •10. History of current or suspected systemic or cutaneous malignancy and or lymphoproliferative disease.
- •11. Current herpes zoster infection
- •12. Evidence of tuberculosis infection or history of incompletely treated or untreated tuberculosis.
- •13. 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.
- •14. Participation in any other trial within 1 month prior to screening.
- •15. Subjects with clinical significant 12-lead ECG findings at screening as below:
- •Ã¢â?¬Â¢ QTcF >450msec for males
- •Ã¢â?¬Â¢ Heart rate < 45 or > 100 beats/minutes (inclusive)
- •Ã¢â?¬Â¢ Rhythm disturbance other than sinus arrhythmia or ectopic supraventricular rhythm
- •Ã¢â?¬Â¢ 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
- •Ã¢â?¬Â¢ Acute or chronic signs of ischemia
- •Ã¢â?¬Â¢ Left bundle branch block
- •Ã¢â?¬Â¢ History of myocardial infarction
- •Ã¢â?¬Â¢ Any ECG abnormality which may, in the opinion of the investigator, may represent risk to the subject while participating in the study
研究者
相似试验
尚未招募
4 期
To Assess the Safety and Efficacy of Imusil tablet in Treatment of Adult Subjects with mild COVID-19CTRI/2022/02/040687Glowderma Lab Private Limited
招募中
3 期
A comparative Phase III clinical study of Insulin Glargine in Adults with Type 2 Diabetes.CTRI/2021/11/037994M J Biopharm Pvt Ltd
尚未招募
不适用
Safety and Efficacy of Artemisinin 500 mg capsule in Treatment of Adult Subjects with COVID-19Corona Virus COVID-19PACTR202012892855610Oncotelic Incorporated120
招募中
4 期
Phase IV study to evaluate the safety and efficacy of Artemisinin- a herbal supplement on COVID-19 subjectsCTRI/2020/09/028044Windlas Biotech Private Limited
进行中（未招募）
1 期
Evaluation of Equine antibody treatment in patient with COVID 19 infectioCTRI/2021/02/031566Bharat Serums and Vaccines ltd