A Prospective, Multicentric, Open Label, Bio-Interventional, Phase I/II Pilot Study To Evaluate The Safety And Efficacy Of Autologous Human Platelet Lysate (HPL) For Treatment of Facial Wrinkles (Nasolabial Folds)
Sponsor study identifier
interventional
20
1 country
1
Study Start
April 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, pilot study to evaluate safety and efficacy of Autologous Human Platelet Lysate (HPL) in subjects with Facial Wrinkles (Nasolabial Folds). The study is being conducted at 2 centers in India. The primary endpoints are Improvement in Wrinkle Severity Rating Scale ( WSRS ) as per ATLAS photographic grading at rest and on full smile and Global Aesthetic Improvement Scale (GAIS). The secondary endpoints are improvement in photographic assessment, Physician's assessment scores, Patient's assessment scores form enrollment 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.
April 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.
Wrinkle Severity Rating Scale as per ATLAS photographic grading at rest & on full smile
Day 0, End of Study - 3 months
Global Aesthetic Improvement Scale
Day 0, End of study - Month 3
Photographic assessments
Day 0, Month 1, Month 2, End of study - Month 3
Physician's assessment scores
End of Study - 3 months
Patient's assessment scores
End of Study - 3 months
All subjects will receive a single injection of Autologous Human Platelet Lysate in the nasolabial region
All subjects will receive a single injection of Autologous Human Platelet Lysate in the nasolabial region
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
Rachita Dhurat, Dr.
Dr Rachita's Skin, Trichology & Aesthetic Centre
Geetanjali Shetty, Dr.
Kapadia Multispeciality Hospital
First Submitted
July 17, 2012
First Posted
July 19, 2012
Study Start
April 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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