Study To Determine Safety & Efficacy Of Autologous Human Platelet Lysate in Androgenetic Alopecia After Hair Transplant

Phase 1

• Conditions: Androgenetic Alopecia
• Interventions: Biological: Autologous Human Platelet Lysate; Other: Standard hair follicle transplant

• Registration Number: NCT01644422
• 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 undergoing hair transplantation. The study is being conducted at 2 centers in India. The primary endpoints are Increase in Hair Follicle viability after transplant, 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: 2012-07-17
• Study First Submitted QC: 2012-07-17
• Study First Posted: 2012-07-19
• 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: 30

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 unwilling to or unable to comply with the study protocol.
• Subjects taking concomitant therapy that might interfere with the study results in investigators opinion or participating in another trial in the past 30 days.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study arm A	Autologous Human Platelet Lysate	Subjects will receive hair follicles transplants that are dipped in HPL before transplant
Study arm B	Autologous Human Platelet Lysate	Subjects will receive hair follicles transplants that are dipped in HPL before transplant; followed by one HPL injection one week after transplant
Control arm C	Standard hair follicle transplant	Subject will receive Standard hair follicle transplant

Primary Outcome Measures

Name	Time	Method
Improvement in Calibre & Density of Hair as assessed by Folliscope	Day 0, Month 2, End of Study - Month 4

Secondary Outcome Measures

Name	Time	Method
Photographic assessment	Day 0, Month 1, Month 2, Month 3, End of Study - Month 4

Trial Locations

Locations (1)

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