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

Phase 1

Completed

• Conditions: ACNE SCARRING
• Interventions: Biological: Autologous Human Platelet Lysate

• Registration Number: NCT01644435
• Lead Sponsor: Kasiak Research Pvt. Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-07-17
• Study First Submitted QC: 2012-07-17
• Study First Posted: 2012-07-19
• Status Verified: 2012-10
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Last Update Submitted: 2012-10-12
• Last Update Posted: 2012-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study arm A	Autologous Human Platelet Lysate	Subjects will receive a single injection of Autologous Human Platelet Lysate for acne scarring
Study arm B	Autologous Human Platelet Lysate	Subjects will receive two injections of Autologous Human Platelet Lysate at an interval of one month for acne scarring.

Primary Outcome Measures

Name	Time	Method
Changes in the Global Acne scarring classification	Day 0, End of study - Month 3

Secondary Outcome Measures

Name	Time	Method
Photographic Assessment	Day 0, Month 1, Month 2 End of study - Month 3

Trial Locations

Locations (1)

Kasiak Research Pvt Ltd; 🇮🇳 Thane, Maharashtra, India