A Study to Determine the Safety and Efficacy of Autologous Human Platelet Lysate for Treatment of Androgenetic Alopecia

Phase 1

• Conditions: Androgenetic Alopecia

• Registration Number: NCT01643629
• Lead Sponsor: Kasiak Research Pvt. Ltd.

Brief Summary

This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of Human Platelet Lysate (HPL) in subjects with Androgenetic Alopecia. The study is being conducted at 2 centers in India. The primary endpoints are Improvement in Caliber \& Density of hair and Improvement in Photographic assessment from randomization to end of study. The secondary endpoints are Physicians and Patients self assessment score.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Status Verified: 2012-07
• Study First Submitted: 2012-07-12
• Study First Submitted QC: 2012-07-16
• Study First Posted: 2012-07-18
• Last Update Submitted: 2012-07-24
• Last Update Posted: 2012-07-25
• Primary Completion: 2012-10
• Study Completion: 2012-11

Recruitment & Eligibility

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

Inclusion Criteria

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

Exclusion Criteria

• Subjects aged <18 or > 50 years
• Subjects with dermatological disorder of scalp that might interfere with study evaluation
• Subjects on Anti-coagulant therapy
• 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
• Subjects unwilling to or unable to comply with the study protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Calibre & Density of Hair as assessed by Folliscope	Day 0, Month 4, End of study - Month 6

Secondary Outcome Measures

Name	Time	Method
Photographic Assessment	Day 0, Month1, Month 2, Month 3, Month 4, Month 5, Month 6

Trial Locations

Locations (1)

Kasiak Research Pvt Ltd; 🇮🇳 Thane, Maharashtra, India