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

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01643629

Enrollment

Registered

2012-07-18

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. 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.

Interventions

BIOLOGICALAutologous 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.

OTHER2 % Minoxidil and /or Finasteride

Control arm B subjects will receive Standard therapy (2% Minoxidil and/or Finasteride)

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 with dermatological disorder of scalp that might interfere with study evaluation * Subjects unwilling to or unable to comply with the study protocol.

Design outcomes

Primary

Measure	Time frame
Change in Calibre & Density of Hair as assessed by Folliscope	Day 0, Month 4, End of study - Month 6

Secondary

Measure	Time frame
Photographic Assessment	Day 0, Month1, Month 2, Month 3, Month 4, Month 5, Month 6

Other

Measure	Time frame
Physician's Assessment Score	End of study - Month 6
Patient's Assessment Score	End of study - Month 6

Countries

India

Outcome results

None listed

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