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

Kasiak Research

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Facial Wrinkles (Nasolabial Folds)

Treatments

Other: Autologous Human Platelet Lysate

Study type

Interventional

Funder types

Industry

Identifiers

NCT01644461

KRPL/HPL-FR/11-12/002B

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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