A comparative study to determine the safety and efficacy of Autologous Human Platelet Lysate (HPL)for Treatment of Androgenetic Alopecia (AGA)

Phase 1/2

Completed

• Conditions: Androgenetic Alopecia

• Registration Number: CTRI/2012/04/002614
• Lead Sponsor: Kasiak Research Pvt Ltd

Brief Summary

This is a multicentre, openlabel, randomized, pilot study to evaluate safety and efficacy of HumanPlatelet Lysate (HPL) in subjects with Androgenetic Alopecia. The study isbeing conducted at 2 centers in India. The primary endpoints are Improvement inCaliber & Density of hair and Improvement in Photographic assessment from randomizationto end of study. The secondary endpoints are Physicians and Patients selfassessment score.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-25
• Last Update Posted: 2013-10-04

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

1.Male subjects, aged between 18 to 50 years (both inclusive) and in general good health 2.Subjects willing to refrain from other AGA treatments during the entire study duration 3.Subjects who are willing to give informed consent and adhere to the study protocol.

Exclusion Criteria

• 1.Subjects aged <18 or > 50 years 2.
• Subjects with dermatological disorder of scalp that might interfere with study evaluation 3.Subjects on Anti-coagulant therapy 4.Subjects with clinically significant medical or psychiatric disease as determined by the investigator.
• Subjects with dermatological disorder of scalp that might interfere with study evaluation 6.
• Subjects unwilling to or unable to comply with the study protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Improvement in Calibre & Density of Hair as assessed by Folliscope	End of Study- 6 Months
2.Photographic assessment from randomization to end of study	End of Study- 6 Months

Secondary Outcome Measures

Name	Time	Method
1.Physician’s assessment score	2.Patient’s self assessment score

Trial Locations

Locations (2)

Dr. Rajesh Rajput Hair Restore; 🇮🇳 Mumbai, MAHARASHTRA, India

Hair Revive; 🇮🇳 Mumbai, MAHARASHTRA, India

Dr. Rajesh Rajput Hair Restore

🇮🇳Mumbai, MAHARASHTRA, India

Dr Rajendarsingh Rajput

Principal investigator

022-26415298

drrajeshrajput@gmail.com