A pilot study to determine the safety and efficacy of Autologous Human Platelet Lysate (HPL) in treatment of Acne Scarring

Phase 1/2

Completed

• Conditions: Acne Scarring

• Registration Number: CTRI/2012/06/002732
• 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: 2012-05-21
• Last Update Posted: 2013-10-04

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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 known bleeding disorders such as platelet dysfunction syndrome, thrombocytopenia, hypofibrinogenemia.
• Subjects who have received prior chemotherapy and radiotherapy 7.
• 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: Not specified

Primary Outcome Measures

Name	Time	Method
•Changes in the Global Acne scarring classification scores from screening to end of the study.	End of study - 4 Months

Secondary Outcome Measures

Name	Time	Method
• Photographic Assessment	• Physician’s assessment scores for acne scarring.

Trial Locations

Locations (2)

Dermocosmetic laser center hair and skin clinic; 🇮🇳 Thane, MAHARASHTRA, India

Radiance Cosmetology Clinique; 🇮🇳 Mumbai, MAHARASHTRA, India

Dermocosmetic laser center hair and skin clinic

🇮🇳Thane, MAHARASHTRA, India

Dr Sharmila Patil

Principal investigator

022-25405537

drsharmilapatil@gmail.com