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

July 24, 2012 updated by: Kasiak Research Pvt. Ltd.

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Thane, Maharashtra, India, 400610
        • Kasiak Research Pvt Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Study Group
All subjects will receive a single injection of Autologous Human Platelet Lysate in the nasolabial region
Other: Autologous Human Platelet Lysate
All subjects will receive a single injection of Autologous Human Platelet Lysate in the nasolabial region

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Global Aesthetic Improvement Scale
Time Frame: Day 0, End of study - Month 3
Day 0, End of study - Month 3

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasiak Research Pvt. Ltd.

Investigators

  • Principal Investigator: Rachita Dhurat, Dr., Dr Rachita's Skin, Trichology & Aesthetic Centre
  • Principal Investigator: Geetanjali Shetty, Dr., Kapadia Multispeciality Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ANTICIPATED)

October 1, 2012

Study Completion (ANTICIPATED)

November 1, 2012

Study Registration Dates

First Submitted

July 17, 2012

First Submitted That Met QC Criteria

July 17, 2012

First Posted (ESTIMATE)

July 19, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 25, 2012

Last Update Submitted That Met QC Criteria

July 24, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KRPL/HPL-FR/11-12/002B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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