CTRI/2009/091/001054
Completed
Phase 3
A prospective, randomized, double blind, placebo controlled, two arm, parallel assignment study to evaluate clinical efficacy and safety of Hair growth Lotion + Tablet in the management of Androgenic alopecia (AGA).
Meyer Organics Pvt Ltd Thane0 sites60 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Reducing hair loss, to increase hair growth and to improve scalp conditions in the androgenic alopecia.
- Sponsor
- Meyer Organics Pvt Ltd Thane
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men aged 18 to 49 years with mild to moderate signs of AGA, which is classified in Modified Norwood\-Hamilton Scale as stage 3V, 4 and 5\.
- •Not be on a course of treatment, which affects the outcome of the study.
- •Individuals who are willing to give informed consent and willing to follow up.
- •No topical treatment for AGA for at least 6 weeks and no systemic treatment for at least 3 months prior to study initiation.
- •Willing to refrain from other AGA treatments during the course of the study.
- •Not have had hair chemically treated (including colored hair, permed hair, etc) within the month prior to the study.
Exclusion Criteria
- •Coexistent androgenetic alopecia other than 3V, 4 and 5 stages of Norwood\-Hamilton scale
- •Unwilling to maintain a consistent hair style and to avoid shaving of scalp hair throughout the course of the study.
- •Unable to comply with the protocol.
- •Patients who are on chronic oral steroids are not eligible for the study
- •Allergies to Investigational product.
- •Presence of irritated or visibly inflamed scalp.
- •Use of ultraviolet radiation, including tanning beds and PUVA therapy for treatment of acne, psoriasis, or any other skin condition within 2 months prior to study initiation.
- •Evidence of immunocompromise.
- •Advanced or poorly controlled diabetes.
- •Unstable cardiovascular disease.
Outcomes
Primary Outcomes
Not specified
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