Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kasiak Research Pvt. Ltd.
ClinicalTrials.gov Identifier:
NCT01644461
First received: July 17, 2012
Last updated: July 24, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Facial Wrinkles (Nasolabial Folds)
 Other: Autologous Human Platelet Lysate
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Further study details as provided by Kasiak Research Pvt. Ltd.:

Primary Outcome Measures:
  • Wrinkle Severity Rating Scale as per ATLAS photographic grading at rest & on full smile [ Time Frame: Day 0, End of Study - 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Global Aesthetic Improvement Scale [ Time Frame: Day 0, End of study - Month 3 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Photographic assessments [ Time Frame: Day 0, Month 1, Month 2, End of study - Month 3 ] [ Designated as safety issue: No ]
  • Physician's assessment scores [ Time Frame: End of Study - 3 months ] [ Designated as safety issue: No ]
  • Patient's assessment scores [ Time Frame: End of Study - 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: April 2012
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Autologous Human Platelet Lysate

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01644461

Locations
India
Kasiak Research Pvt Ltd
Thane, Maharashtra, India, 400610
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Kasiak Research Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT01644461     History of Changes
Other Study ID Numbers: KRPL/HPL-FR/11-12/002B
Study First Received: July 17, 2012
Last Updated: July 24, 2012
Health Authority: India: Institutional Review Board

Additional relevant MeSH terms:
Facies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013