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A study for Evaluation of effectiveness and Safety of Minoxidil (5%) plus Finasteride (0.1%) Solution in Adult Male Patients with Androgenetic Alopecia

Phase 4
Completed
Conditions
Health Condition 1: L649- Androgenic alopecia, unspecified
Registration Number
CTRI/2016/03/006724
Lead Sponsor
Intas Pharmaceuticals Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
160
Inclusion Criteria

1. Male patients in good general physical and mental health, with Androgenetic alopecia.

2. Subjects willing to provide written informed consent, indicating that they thoroughly understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria

1. Concomitant dermatological disorders on the scalp other than Androgenetic alopecia.

2. Serious cardiovascular diseases (uncontrolled hypertension, angina pectoris, myocardial infarction, etc.), renal diseases or hepatic diseases.

3. History of drug hypersensitivity (including contact dermatitis to cosmetics), breast disorders (including gynecomastia, breast enderness) or testicular disorders (testicular growth, testicular pain).

4. History of treatment with a systemic or locally acting medication which may interfere with the study objectives, such as Minoxidil treatment in the 06 months prior to dosing, Finasteride treatment in the 12 months prior to dosing, or treatment with other investigational hair growth products in the 06 months prior to dosing

5. Ongoing use of prohibited medications (as specified in the protocol)

6. Use of any investigational product within 03 months prior dosing of study drug

7. Judged by the investigator as otherwise being unsuitable for participation in this trial.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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