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

Phase 1

• Conditions: Periorbital Hyperpigmentation (Dark Circles)
• Interventions: Other: Autologous Human Platelet Lysate; Other: Standard Therapy

• Registration Number: NCT01644448
• Lead Sponsor: Kasiak Research Pvt. Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Status Verified: 2012-07
• Study First Submitted: 2012-07-17
• Study First Submitted QC: 2012-07-17
• Study First Posted: 2012-07-19
• Last Update Submitted: 2012-07-24
• Last Update Posted: 2012-07-25
• Primary Completion: 2012-10
• Study Completion: 2012-11

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study arm A	Autologous Human Platelet Lysate	Subjects will receive one dose of 5 ml of Autologous Human Platelet Lysate with simultaneous micro-needling on day 2
Control Arm B	Standard Therapy	Topical Applications of the standard therapy as directed by the investigator

Primary Outcome Measures

Name	Time	Method
Photographic Assessment	Day 0, Month 1, Month 2, End of Study - 3 months

Trial Locations

Locations (1)

Kasiak Research Pvt Ltd; 🇮🇳 Thane, Maharashtra, India