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

NCT01644461 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-07-25

No results posted yet for this study

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.

Conditions

  • Facial Wrinkles (Nasolabial Folds)

Interventions

OTHER

Autologous Human Platelet Lysate

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

Sponsors & Collaborators

  • Kasiak Research Pvt. Ltd.

    lead INDUSTRY

Principal Investigators

  • Rachita Dhurat, Dr. · Dr Rachita's Skin, Trichology & Aesthetic Centre

  • Geetanjali Shetty, Dr. · Kapadia Multispeciality Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-10-31
Completion
2012-11-30

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01644461 on ClinicalTrials.gov