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

Kasiak Research Pvt. Ltd.1 site in 1 country19 target enrollmentMay 2012

ConditionsACNE SCARRING

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: ACNE SCARRING
Sponsor: Kasiak Research Pvt. Ltd.
Enrollment: 19
Locations: 1
Primary Endpoint: Changes in the Global Acne scarring classification
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2012

End Date

October 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kasiak Research Pvt. Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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