NCT01644422

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

A Prospective Multicentric Open Label Randomized Bio-Interventional Phase I/II Pilot Study To Evaluate Safety & Efficacy Of Autologous Human Platelet Lysate For Treatment Of Androgenetic Alopecia In Patients Undergoing Hair Transplant

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Kasiak Research Pvt. Ltd. · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Androgenetic Alopecia

Interventions

Type	Name	Description
BIOLOGICAL	Autologous Human Platelet Lysate	Study arm A subjects will receive hair follicles transplants that are dipped in HPL before transplant
BIOLOGICAL	Autologous Human Platelet Lysate	Study arm B subjects will receive hair follicles transplants that are dipped in HPL before transplant; followed by one HPL injection
OTHER	Standard hair follicle transplant	Control arm subject will receive Standard hair follicle transplant

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-10-01
• Completion: 2012-11-01
• First posted: 2012-07-19
• Last updated: 2012-07-25

Locations

1 site across 1 country: India