Overview

This trial is active, not recruiting.

Condition facial wrinkles (nasolabial folds)
Treatment autologous human platelet lysate
Phase phase 1/phase 2
Sponsor Kasiak Research Pvt. Ltd.
Start date April 2012
End date October 2012
Trial size 20 participants
Trial identifier NCT01644461, KRPL/HPL-FR/11-12/002B

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
All subjects will receive a single injection of Autologous Human Platelet Lysate in the nasolabial region
autologous human platelet lysate Autologous Human Platelet Lysate
All subjects will receive a single injection of Autologous Human Platelet Lysate in the nasolabial region

Primary Outcomes

Measure
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

Measure
Global Aesthetic Improvement Scale
time frame: Day 0, End of study - Month 3

Eligibility Criteria

Male or female participants from 18 years up to 40 years old.

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

Additional Information

Official title 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)
Principal investigator Rachita Dhurat, Dr.
Trial information was received from ClinicalTrials.gov and was last updated in July 2012.
Information provided to ClinicalTrials.gov by Kasiak Research Pvt. Ltd..