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

Kasiak Research

Status and phase

Completed

Phase 2

Phase 1

Conditions

ACNE SCARRING

Treatments

Biological: Autologous Human Platelet Lysate

Study type

Interventional

Funder types

Industry

Identifiers

NCT01644435

KRPL/HPL-AS/11-12/004

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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