A Prospective Multicentric Open Label Randomized Bio-Interventional Phase I/II Pilot Study To Evaluate Safety & Efficacy Of Autologous Human Platelet Lysate (HPL) for Treatment of Periorbital Hyperpigmentation (Dark Circles)

Kasiak Research Pvt. Ltd.1 site in 1 country20 target enrollmentMarch 2012

ConditionsPeriorbital Hyperpigmentation (Dark Circles)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Periorbital Hyperpigmentation (Dark Circles)
Sponsor: Kasiak Research Pvt. Ltd.
Enrollment: 20
Locations: 1
Primary Endpoint: Photographic Assessment
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 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.

Registry

clinicaltrials.gov

Start Date

March 2012

End Date

November 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 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.