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

Phase 1

• Conditions: Facial Wrinkles (Nasolabial Folds)
• Interventions: Other: Autologous Human Platelet Lysate

• Registration Number: NCT01644461
• Lead Sponsor: Kasiak Research Pvt. Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Status Verified: 2012-07
• Study First Submitted: 2012-07-17
• Study First Submitted QC: 2012-07-17
• Study First Posted: 2012-07-19
• Last Update Submitted: 2012-07-24
• Last Update Posted: 2012-07-25
• Primary Completion: 2012-10
• Study Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Group	Autologous Human Platelet Lysate	All subjects will receive a single injection of Autologous Human Platelet Lysate in the nasolabial region

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Global Aesthetic Improvement Scale	Day 0, End of study - Month 3

Trial Locations

Locations (1)

Kasiak Research Pvt Ltd; 🇮🇳 Thane, Maharashtra, India