A Study to Determine the Safety & Efficacy of Autologous Human Platelet Lysate (HPL) in Treatment of Dark Circles

Kasiak Research

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Periorbital Hyperpigmentation (Dark Circles)

Treatments

Other: Standard Therapy

Other: Autologous Human Platelet Lysate

Study type

Interventional

Funder types

Industry

Identifiers

NCT01644448

KRPL/HPL-FR/11-12/002A

Details and patient eligibility

About

This is a multicentre, open label, randomized, pilot study to evalute safety and efficacy of Human Platelet Lysate (HPL) in subjects with Periorbital Hyperpigmentation. The study is being conducted at 2 centers in India.The primary endpoints are Physicians and Patient Self assessment score. The secondary endpoints are improvement in photographic assessment form randomization to end of study.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects (male and female), aged 18 to 55 years (both inclusive) with Periorbital Hyperpigmentation.
Subject willing to refrain from any other treatment of Periorbital Hyperpigmentation during entire study duration.
Subjects who are willing to give informed consent and adhere to the study protocol.

Exclusion criteria

Subjects aged less than 18 and more than 55 years
Subjects with history of connective tissue disease.
Subjects with metabolic or hematopoietic disorders
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 30 days.