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Pan Facial Volume Restoration

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01545557
First Posted: March 6, 2012
Last Update Posted: March 26, 2014
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):
Galderma
February 24, 2012
March 6, 2012
March 26, 2014
February 2012
February 2014   (Final data collection date for primary outcome measure)
Volume loss assessment percent change from baseline [ Time Frame: Baseline, 3 weeks after baseline injections, 3 weeks after touch up injections (Optional), 3 months after the last injections, 6 months after the last injections, 12 months after the last injections, 18 months after the last injections ]
The investigator will assess volume loss by indication and overall (whole face).
Same as current
Complete list of historical versions of study NCT01545557 on ClinicalTrials.gov Archive Site
  • Subject satisfaction [ Time Frame: Three weeks after the last injections (Visit 2 or Vissit 3 if touch-up) and at last study visit (18 months after the last injections) ]
    Subject satisfaction will be assessed at visit 2 or visit 3 (if touch up injections) and at last study visit (18 months after the last injection) through a satisfaction questionnaire
  • Investigator satisfaction [ Time Frame: At end of the study (18 months after last injections) ]
    Investigators will complete a questionnaire after the last visit of the last subject.
  • Safety assessment [ Time Frame: Baseline, 3 weeks after baseline injections, 3 weeks after touch up injections (optional), 3 months after the last injections, 6 months after the last injections, 12 months after the last injections, 18 months after the last injections, ]
    Incidence of Adverse Event will be reported
  • Subject satisfaction [ Time Frame: Three weeks after the last injections (Visit 2 or Vissit 3 if touch-up) and at last study visit (18 months after the last injections) ]
    Subject satisfaction will be assessed at visit 2 or visit 3 (if touch up injections) and at last study visit (18 months after the last injection) through a satisfaction questionnaire
  • Investigator satisfaction [ Time Frame: At end of the study (18 months after last injections) ]
    Investigators will complete a questionnaire after the last visit of thelast subject.
  • Safety assessment [ Time Frame: Baseline, 3 weeks after baseline injections, 3 weeks after touch up injections (optional), 3 months after the last injections, 6 months after the last injections, 12 months after the last injections, 18 months after the last injections, ]
    Incidence of Adverse Event will be reported
Not Provided
Not Provided
 
Pan Facial Volume Restoration
Pan Facial Volume Restoration With a New Hyaluronic Acid Dermal Filler
The aim of this study is to assess performance and tolerance as well as investigator and subject satisfaction further to pan-facial volume restoration with a new cross-linked hyaluronic acid dermal filler containing lidocaine 0.3%.

Clinical hypothesis: The global approach of the subject pan-facial dermal volume depletion and face soft-tissue contour defects correction using specific dermal filler for all indications to be injected will satisfy both subjects and investigators.

This device will be used for full face correction of volume loss: chin, temporal areas, jawline, cheek, cheekbones, deep to very deep nasolabial folds (only if cheekbones are injected concomitantly).

Study duration will be up to 19 months. Injections will be performed at baseline. If necessary, investigator will perform touch-up injections at the following visit (3 weeks after baseline injection).

Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Volume Loss
Device: Hyaluronic acid dermal filler gel
1 injection per indication and 1 touch-up injection if necessary
Other Name: Study filler is Emervel Volume Lidocaine.
Experimental: Hyaluronic acid
Intervention: Device: Hyaluronic acid dermal filler gel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
February 2014
February 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects seeking treatment for correction of volume loss.
  • Subjects presenting a score of 2 (visible depression or descent) for whole face on the volume loss scale and at least 2 indications affected by volume loss among the following: chin temporal areas, jawlines, cheeks, cheekbones, deep to very deep nasolabial folds (severity score 4 at least on Lemperle rating scale) if cheekbones are injected.

Exclusion Criteria:

  • Subjects at risk in term of precautions, warnings and contraindication referred in the package insert of the study device,
  • Subjects who underwent previous injection of permanent filler in the injected area.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01545557
RD.03.CIP.29090
No
Not Provided
Not Provided
Galderma
Galderma
Not Provided
Principal Investigator: Sergio Talarico, MD Säo Paulo (Brazil)
Galderma
March 2014

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