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

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)

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01644461

Enrollment

Registered

2012-07-19

Start date

2012-04-30

Completion date

2012-11-30

Last updated

2012-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facial Wrinkles (Nasolabial Folds)

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.

Interventions

OTHERAutologous Human Platelet Lysate

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

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

Design outcomes

Primary

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

Secondary

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

Other

Measure	Time frame
Photographic assessments	Day 0, Month 1, Month 2, End of study - Month 3
Physician's assessment scores	End of Study - 3 months
Patient's assessment scores	End of Study - 3 months

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026