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Pan Facial Volume Restoration

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT01545557
First received: February 24, 2012
Last updated: November 6, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention Phase
Volume Loss
 Device: Hyaluronic acid dermal filler gel
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pan Facial Volume Restoration With a New Hyaluronic Acid Dermal Filler

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Galderma:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    The investigator will assess volume loss by indication and overall (whole face).


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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, ] [ Designated as safety issue: Yes ]
    Incidence of Adverse Event will be reported


Enrollment: 60
Study Start Date: February 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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)
  More Information

No publications provided

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01545557     History of Changes
Other Study ID Numbers: RD.03.CIP.29090
Study First Received: February 24, 2012
Last Updated: November 6, 2012
Health Authority: Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency

Keywords provided by Galderma:
Volume loss

Additional relevant MeSH terms:
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013