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

Kasiak Research Pvt. Ltd.1 site in 1 country30 target enrollmentJanuary 2012

ConditionsAndrogenetic Alopecia

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Androgenetic Alopecia
Sponsor: Kasiak Research Pvt. Ltd.
Enrollment: 30
Locations: 1
Primary Endpoint: Improvement in Calibre & Density of Hair as assessed by Folliscope
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

November 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Kasiak Research Pvt. Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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.