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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Androgenetic Alopecia

Intervention / Treatment
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* Biological: Autologous Human Platelet Lysate (HPL)
* Other: 2 % Minoxidil and /or Finasteride


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study arm A<br>Study arm A will include subjects receiving three doses of Autologous Human Platelet Lysate at an interval of one month each. | Biological: Autologous Human Platelet Lysate (HPL)<br>* Study arm A will include subjects receiving three doses of Autologous Human Platelet Lysate at an interval of one month each.<br>|
| Other: Control Arm B<br>Control arm B will include subjects receiving Standard therapy | Other: 2 % Minoxidil and /or Finasteride<br>* Control arm B subjects will receive Standard therapy (2% Minoxidil and/or Finasteride)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photographic Assessment |  | Day 0, Month1, Month 2, Month 3, Month 4, Month 5, Month 6 |