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)

Kasiak Research Pvt. Ltd.1 site in 1 country20 target enrollmentApril 2012

ConditionsFacial Wrinkles (Nasolabial Folds)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Facial Wrinkles (Nasolabial Folds)
Sponsor: Kasiak Research Pvt. Ltd.
Enrollment: 20
Locations: 1
Primary Endpoint: Wrinkle Severity Rating Scale as per ATLAS photographic grading at rest & on full smile
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

clinicaltrials.gov

Start Date

April 2012

End Date

November 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Kasiak Research Pvt. Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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