NCT01643629

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

A Prospective Multicentric Open Label Randomized Bio-Interventional Phase I/II Pilot Study To Evaluate The Safety And Efficacy Of Autologous Human Platelet Lysate (HPL) For Treatment Of Androgenetic Alopecia (AGA)

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (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. 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.

Conditions

• Androgenetic Alopecia

Interventions

Type	Name	Description
BIOLOGICAL	Autologous Human Platelet Lysate (HPL)	Study arm A will include subjects receiving three doses of Autologous Human Platelet Lysate at an interval of one month each.
OTHER	2 % Minoxidil and /or Finasteride	Control arm B subjects will receive Standard therapy (2% Minoxidil and/or Finasteride)

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-10-01
• Completion: 2012-11-01
• First posted: 2012-07-18
• Last updated: 2012-07-25

Locations

1 site across 1 country: India