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A Post-Market Study to Evaluate Adverse Event Incidence Rates in Patients With Skin of Color Undergoing Correction of Nasolabial Folds With Hylaform, Hylaform Plus and Captique.

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.
 
ClinicalTrials.gov Identifier: NCT00293163
Recruitment Status : Completed
First Posted : February 17, 2006
Last Update Posted : March 5, 2015
Sponsor:
Collaborator:
Inamed Aesthetics
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE February 16, 2006
First Posted Date  ICMJE February 17, 2006
Last Update Posted Date March 5, 2015
Study Start Date  ICMJE February 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2006)
  • no difference in keloid and scar formation
  • pigmentation disorders
  • hypersensitivity reactions in patients with skin color compared to other patients when treated for wrinkle correction with Hylaform, Hylaform Plus or Captique
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Post-Market Study to Evaluate Adverse Event Incidence Rates in Patients With Skin of Color Undergoing Correction of Nasolabial Folds With Hylaform, Hylaform Plus and Captique.
Official Title  ICMJE Not Provided
Brief Summary To assess the likelihood of keloid and scar formation, pigmentation disorders and hypersensitivity reactions in patients with skin of color undergoing correction of facial soft tissue contour deficiencies with Hylaform, Hylaform Plus or Captique.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Facial Wrinkles
Intervention  ICMJE Device: Hylaform, Hylaform Plus (hylan B gel)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: February 16, 2006)
120
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • bilateral nasolabial folds with severity score 3 or 4 on the 6-point grading scale

Exclusion Criteria:

  • pregnant/lactating women
  • patients who previously received permanent facial implants or using over-the-counter products
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00293163
Other Study ID Numbers  ICMJE HYLA00204
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical Monitor, Genzyme Corporation
Study Sponsor  ICMJE Genzyme, a Sanofi Company
Collaborators  ICMJE Inamed Aesthetics
Investigators  ICMJE
Study Director: Medical Monitor Genzyme, a Sanofi Company
PRS Account Sanofi
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP