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

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01644422

Enrollment

Registered

2012-07-19

Start date

2012-01-31

Completion date

2012-11-30

Last updated

2012-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Androgenetic Alopecia

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.

Interventions

OTHERStandard hair follicle transplant

Control arm subject will receive Standard hair follicle transplant

BIOLOGICALAutologous Human Platelet Lysate

Study arm A subjects will receive hair follicles transplants that are dipped in HPL before transplant

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Other

Measure	Time frame
Physician's assessment score	End of Study - Month 4
Patient's self assessment score	End of Study - Month 4

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026