A Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate (HPL) in Facial Wrinkles(Nasolabial Folds)
This trial is active, not recruiting.
|Condition||facial wrinkles (nasolabial folds)|
|Treatment||autologous human platelet lysate|
|Phase||phase 1/phase 2|
|Sponsor||Kasiak Research Pvt. Ltd.|
|Start date||April 2012|
|End date||October 2012|
|Trial size||20 participants|
|Trial identifier||NCT01644461, KRPL/HPL-FR/11-12/002B|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Wrinkle Severity Rating Scale as per ATLAS photographic grading at rest & on full smile
time frame: Day 0, End of Study - 3 months
Global Aesthetic Improvement Scale
time frame: Day 0, End of study - Month 3
Male or female participants from 18 years up to 40 years old.
Inclusion Criteria: - Subjects (male and female), aged 18 to 40 years (both inclusive). - Subjects willing to refrain from any other treatment for Nasolabial Folds. - Subjects who are willing to give informed consent and adhere to the study protocol. Exclusion Criteria: - Subjects receiving any aesthetic facial therapy 6 months prior to enrolment e.g. Botox, Fillers etc - Subjects with history of Connective tissue disease - Subjects with autoimmune diseases - Subjects unwilling to or unable to comply with the study protocol. - Subjects taking concomitant therapy that might interfere with the study results in the investigator's opinion or participating in another trial in the past 30days
|Official title||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)|
|Principal investigator||Rachita Dhurat, Dr.|
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