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)
Sponsor study identifier
interventional
20
1 country
1
Study Start
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
July 17, 2012
Actual (reported)July 19, 2012
Actual (reported)October 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Photographic Assessment
Day 0, Month 1, Month 2, End of Study - 3 months
Physician's assessment scores
End of Study - 3 months
Patient's assessment scores
End of Study - 3 months
Subjects will receive one dose of 5 ml of Autologous Human Platelet Lysate with simultaneous micro-needling on day 2
Topical Applications of the standard therapy as directed by the investigator
Subjects will receive one dose of 5 ml of HPL with simultaneous micro-needling on day 2
Topical Applications as directed by the investigator
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Kasiak Research Pvt Ltd
Thane, Maharashtra, 400610, India
Farida Modi, Dr.
Dermacare
Preeti Savardekar, Dr.
Shree Krishna Polyclinic
Sharmila Patil, Dr.
Dr. Sharmila's Dermocosmetic laser center, hair and skin clinic
First Submitted
July 17, 2012
First Posted
July 19, 2012
Study Start
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2012
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 25, 2012
Record last verified: 2012-07
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