NCT01644448

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

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)

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Kasiak Research Pvt. Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Periorbital Hyperpigmentation (Dark Circles)

Interventions

Type	Name	Description
OTHER	Autologous Human Platelet Lysate	Subjects will receive one dose of 5 ml of HPL with simultaneous micro-needling on day 2
OTHER	Standard Therapy	Topical Applications as directed by the investigator

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-10-01
• Completion: 2012-11-01
• First posted: 2012-07-19
• Last updated: 2012-07-25

Locations

1 site across 1 country: India