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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by Kasiak Research Pvt. Ltd..
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01644461
First Posted: July 19, 2012
Last Update Posted: July 25, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kasiak Research Pvt. Ltd.
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Global Aesthetic Improvement Scale [ Time Frame: Day 0, End of study - Month 3 ]

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

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Kasiak Research Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT01644461     History of Changes
Other Study ID Numbers: KRPL/HPL-FR/11-12/002B
First Submitted: July 17, 2012
First Posted: July 19, 2012
Last Update Posted: July 25, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Facies
Disease Attributes
Pathologic Processes