A Pilot Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate (HPL) in Treatment of Acne Scarring

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 Acne Scarring. The study is being conducted at 2 centers in India. The primary endpoint is change in the Global Acne scarring classification scores from screening to end of the study. The secondary endpoints are Photographic Assessment, Physicians assessment score and Patients self assessment score.

Official Title
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A Prospective, Multicentric, Open Label, Bio Interventional, Phase I, Phase II Pilot Study to Evaluate the Safety and Efficacy of Autologous Human Platelet Lysate (HPL) for Treatment of Acne Scarring

Conditions
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ACNE SCARRING

Intervention / Treatment
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* Biological: Autologous Human Platelet Lysate
* Biological: Autologous Human Platelet Lysate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects (male and female), aged 18 to 40 years (both inclusive). Subject willing to refrain from any other treatment of Acne Scarring during entire study duration. Non-pregnant, non-lactating females who agree to use adequate and acceptable methods of contraception from screening and throughout the course of the study. Subjects who are willing to give informed consent and adhere to the study protocol. Exclusion Criteria: Subjects with active infection or active acne. Subjects receiving treatment: NSAIDs treatment within the last 7 days prior to the study. Subjects with history of connective tissue disease. Subjects with metabolic or hematopoietic disorders. Subjects with known bleeding disorders such as platelet dysfunction syndrome, thrombocytopenia, hypofibrinogenemia. Subjects who have received prior chemotherapy and radiotherapy Subjects unwilling to or unable to comply with the study protocol. Subjects taking concomitant therapy that might interfere with the study results in the investigator's opinion or participating in another trial in the past 30days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

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: Non-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 a single injection of Autologous Human Platelet Lysate for acne scarring | Biological: Autologous Human Platelet Lysate<br>* Subjects will receive a single injection of Autologous Human Platelet Lysate for acne scarring<br>|
| Other: Study arm B<br>Subjects will receive two injections of Autologous Human Platelet Lysate at an interval of one month for acne scarring. | Biological: Autologous Human Platelet Lysate<br>* Subjects will receive two injections of Autologous Human Platelet Lysate at an interval of one month for acne scarring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Global Acne scarring classification |  | Day 0, End of study - Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photographic Assessment |  | Day 0, Month 1, Month 2 End of study - Month 3 |