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)

NCT01644461 Phase 1/Phase 2 UNKNOWN

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.

Details

Lead sponsor	Kasiak Research Pvt. Ltd.
Phase	Phase 1/Phase 2
Status	UNKNOWN
Enrolment	20
Start date	2012-04
Completion	2012-11

Conditions

• Facial Wrinkles (Nasolabial Folds)

Interventions

• Autologous Human Platelet Lysate

Primary outcomes

• Wrinkle Severity Rating Scale as per ATLAS photographic grading at rest & on full smile — Day 0, End of Study - 3 months

Countries

India