Clinical Trial: A Study to Determine the Safety & Efficacy of Autologous Human Platelet Lysate (HPL) in Treatment of Dark Circles
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: 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
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 Summary:
Sponsor: Kasiak Research Pvt. Ltd.
Current Primary Outcome: Photographic Assessment [ Time Frame: Day 0, Month 1, Month 2, End of Study - 3 months ]
Original Primary Outcome: Incidence of all adverse events will be noted [ Time Frame: Randomisation upto End of Study at 3 months ]
Current Secondary Outcome:
Original Secondary Outcome: - Physician's assessment scores - Patient's assessment score - Photographic assessments [ Time Frame: Randomisation and End of study at Month 3 ]
Information By: Kasiak Research Pvt. Ltd.
Dates:
Date Received: July 17, 2012
Date Started: March 2012
Date Completion: November 2012
Last Updated: July 24, 2012
Last Verified: July 2012