A clinical trial to evaluate the efficacy of micronutrients in reducing hair loss, to increase hair growth and to improve scalp conditions in the androgenic alopecia.
- Conditions
- Health Condition 1: null- Reducing hair loss, to increase hair growth and to improve scalp conditions in the androgenic alopecia.
- Registration Number
- CTRI/2009/091/001054
- Lead Sponsor
- Meyer Organics Pvt Ltd Thane
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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.
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.
Clinically significant medical or psychiatric disease as determined by the investigator.
Local infection (e.g. cellulitis, abscess) or systemic infection (e.g. pneumonia, septicemia) within 3 months prior to the first dose of investigational drug.
Those who have donated blood within a month of date of screening evaluation.
Drug or alcohol abuse.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome Measures <br/ ><br> <br/ ><br>Hair count by PTG (Phototrichograms)Timepoint: At baseline, 2,4 and 6 months
- Secondary Outcome Measures
Name Time Method Secondary Outcome Measures <br/ ><br> <br/ ><br>1.Self assessment by Patients <br/ ><br>2.Physical examination of scalp <br/ ><br>3.Hair density rating scale <br/ ><br>4.Global assessment by investigator <br/ ><br>5.Compliance and adverse effects <br/ ><br>Timepoint: 1.after 2 and 4 months <br/ ><br>2.at baseline, after 1, 2, 3 and 4 months <br/ ><br>3.after 2 and 4 months <br/ ><br>4.After treatment completion <br/ ><br>5.Compliance and adverse effects <br/ ><br>