A Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate (HPL) in Facial Wrinkles(Nasolabial Folds)

Kasiak Research Pvt. Ltd.20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Facial Wrinkles (Nasolabial Folds)

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Wrinkle Severity Rating Scale as per ATLAS photographic grading at rest & on full smile

Time frame: Day 0, End of Study - 3 months

Secondary Outcomes

Global Aesthetic Improvement Scale

Time frame: Day 0, End of study - Month 3