Efficacy of amaranthus extract on male pattern hair loss

Phase 2

Completed

• Registration Number: CTRI/2022/07/043774
• Lead Sponsor: Arjuna Natural Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-01-21
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Males 25 to 45 years of age with clinically diagnosed male pattern hair loss (MPHL) measured with Trichoscan.

Willing to maintain the same hairstyle, hair length, and hair color during the entire study and refrain from cutting the scalp hair.

Subjects willing to give written informed consent.

Exclusion Criteria

History of active hair loss due to alopecia areata, scarring alopecia, diffuse telogen effluvium or conditions other than androgenic alopecia.

Any dermatological disorders of the scalp which might interfere with the application of Investigational Medical Product or examination method, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis or scalp atrophy or psychiatric disorder including trichotillomania.

Subjects who have received radiation to the scalp, cancer treatment in the 6 months prior to start of the study or have a plan to do treatments during study.

Evidence of hypogonadism defined as serum testosterone less than 250ng.

Subjects who have had hair transplant or undergoing any medical treatments.

Topical minoxidil, finasteride, phenytoin, 5 alpha reductase inhibitors, isotretinoin, or any other OTC, prescription medication topical or oral herbal supplement for hair growth or medications known to promote hair loss within the past 3 months.

Current or within 2 weeks prior to first dosing use of vasodilating (e.g. Pentoxifylline, nitroglycerine), anticoagulating, immunosuppressive or corticosteroid drugs.

Positive HIV-Antibody, HBs-Antigen or HCV-Antibody-Test, STDs like Syphilis, autoimmune disorders, Diabetes mellitus, Coagulation or iron deficiencies, hypothyroidism or hyperthyroidism.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in the Terminal hair (Non-Vellus hair) density (n/cm2), hair-shaft diameter (mm), and hair growth rate (mm/day)Timepoint: [ Time Frame: Baseline day3 to day 93]

Secondary Outcome Measures

Name	Time	Method
1.Mean change from baseline in the Target area total hair count, thickness (mm) and length (mm) <br/ ><br> <br/ ><br>Timepoint: [ Time Frame: Baseline day3 to day 93]