Study To Determine Safety & Efficacy Of Autologous Human Platelet Lysate in Androgenetic Alopecia After Hair Transplant

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 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.

Official Title
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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

Conditions
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Androgenetic Alopecia

Intervention / Treatment
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* Biological: Autologous Human Platelet Lysate
* Biological: Autologous Human Platelet Lysate
* Other: Standard hair follicle transplant


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 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.

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>Subjects will receive hair follicles transplants that are dipped in HPL before transplant | Biological: Autologous Human Platelet Lysate<br>* Study arm A subjects will receive hair follicles transplants that are dipped in HPL before transplant<br>|
| Other: Study arm B<br>Subjects will receive hair follicles transplants that are dipped in HPL before transplant; followed by one HPL injection one week after transplant | Biological: Autologous Human Platelet Lysate<br>* Study arm B subjects will receive hair follicles transplants that are dipped in HPL before transplant; followed by one HPL injection<br>|
| Other: Control arm C<br>Subject will receive Standard hair follicle transplant | Other: Standard hair follicle transplant<br>* Control arm subject will receive Standard hair follicle transplant<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photographic assessment |  | Day 0, Month 1, Month 2, Month 3, End of Study - Month 4 |