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Pan Facial Volume Restoration

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ClinicalTrials.gov Identifier: NCT01545557
Recruitment Status : Completed
First Posted : March 6, 2012
Last Update Posted : March 26, 2014
Sponsor:
Information provided by (Responsible Party):
Galderma

Brief Summary:
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%.

Condition or disease Intervention/treatment Phase
Volume Loss Device: Hyaluronic acid dermal filler gel Phase 4

Detailed Description:

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).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pan Facial Volume Restoration With a New Hyaluronic Acid Dermal Filler
Study Start Date : February 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Hyaluronic acid 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.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT01545557


Locations
Brazil
Galderma Investigational Center
Botucatu, Brazil
Galderma Investigational Center
Rio de Janeiro, Brazil
Galderma Investigational Center
Saö Paulo, Brazil
Sponsors and Collaborators
Galderma
Investigators
Principal Investigator: Sergio Talarico, MD Säo Paulo (Brazil)

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01545557     History of Changes
Other Study ID Numbers: RD.03.CIP.29090
First Posted: March 6, 2012    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: March 2014

Keywords provided by Galderma:
Volume loss

Additional relevant MeSH terms:
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents