Overview

This trial is active, not recruiting.

Condition androgenetic alopecia
Treatments autologous human platelet lysate, standard hair follicle transplant
Phase phase 1/phase 2
Sponsor Kasiak Research Pvt. Ltd.
Start date January 2012
End date October 2012
Trial size 30 participants
Trial identifier NCT01644422, KRPL/HPL-AGA/11-12/001B

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Subjects will receive hair follicles transplants that are dipped in HPL before transplant
autologous human platelet lysate Autologous Human Platelet Lysate
Study arm A subjects will receive hair follicles transplants that are dipped in HPL before transplant
(Other)
Subjects will receive hair follicles transplants that are dipped in HPL before transplant; followed by one HPL injection one week after transplant
autologous human platelet lysate 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)
Subject will receive Standard hair follicle transplant
standard hair follicle transplant Standard hair follicle transplant
Control arm subject will receive Standard hair follicle transplant

Primary Outcomes

Measure
Improvement in Calibre & Density of Hair as assessed by Folliscope
time frame: Day 0, Month 2, End of Study - Month 4

Secondary Outcomes

Measure
Photographic assessment
time frame: Day 0, Month 1, Month 2, Month 3, End of Study - Month 4

Eligibility Criteria

Male participants from 18 years up to 50 years old.

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.

Additional Information

Official title 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
Principal investigator Rajendarsingh Rajput, Dr.
Trial information was received from ClinicalTrials.gov and was last updated in July 2012.
Information provided to ClinicalTrials.gov by Kasiak Research Pvt. Ltd..