A Study to Determine the Safety and Efficacy of Autologous Human Platelet Lysate for Treatment of Androgenetic Alopecia
This trial is active, not recruiting.
|Treatments||autologous human platelet lysate (hpl), 2 % minoxidil and /or finasteride|
|Phase||phase 1/phase 2|
|Sponsor||Kasiak Research Pvt. Ltd.|
|Start date||January 2012|
|End date||October 2012|
|Trial size||20 participants|
|Trial identifier||NCT01643629, KRPL/HPL-AGA/11-12/001A|
This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of Human Platelet Lysate (HPL) in subjects with Androgenetic Alopecia. The study is being conducted at 2 centers in India. The primary endpoints are Improvement in Caliber & Density of hair and Improvement in Photographic assessment from randomization to end of study. The secondary endpoints are Physicians and Patients self assessment score.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Change in Calibre & Density of Hair as assessed by Folliscope
time frame: Day 0, Month 4, End of study - Month 6
time frame: Day 0, Month1, Month 2, Month 3, Month 4, Month 5, Month 6
Male participants from 18 years up to 50 years old.
Inclusion Criteria: - Male subjects, aged between 18 to 50 years (both inclusive) and in general good health - Subjects willing to refrain from other AGA treatments during the entire study duration - Subjects who are willing to give informed consent and adhere to the study protocol. Exclusion Criteria: - Subjects aged <18 or > 50 years - Subjects with dermatological disorder of scalp that might interfere with study evaluation - Subjects on Anti-coagulant therapy - Subjects with clinically significant medical or psychiatric disease as determined by the investigator. - Subjects with dermatological disorder of scalp that might interfere with study evaluation - Subjects unwilling to or unable to comply with the study protocol.
|Official title||A Prospective Multicentric Open Label Randomized Bio-Interventional Phase I/II Pilot Study To Evaluate The Safety And Efficacy Of Autologous Human Platelet Lysate (HPL) For Treatment Of Androgenetic Alopecia (AGA)|
|Principal investigator||Rajendarsingh Rajput, Dr.|
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