Clinical trial NCT01545557: Pan Facial Volume Restoration
Official title: Pan Facial Volume Restoration With a New Hyaluronic Acid Dermal Filler
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Volume Loss (Soft Tissue Ptosis or Atrophy )
Keywords: Volume loss
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2012-03-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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%.

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 criteria: Inclusion Criteria:

* Subjects seeking treatment for correction of volume loss.
* Subjects presenting a score of at least 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.

Primary outcomes:
measure: Mean Change From Baseline in Volume Loss Assessment
timeFrame: Baseline and 18 Months after last injection
Secondary outcomes:
measure: Percentage of Participants Satisfied or Very Satisfied at 3 Weeks After Last Injection
timeFrame: At 3 Weeks after last injection
measure: Percentage of Investigators Satisfied With the Use of Study Hyaluronic Acid Dermal Filler
timeFrame: Baseline up to 18 Months after last injection
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Baseline up to 18 Months after last injection
measure: Percentage of Participants Satisfied or Very Satisfied at 18 Months After Last Injection
timeFrame: At 18 Months after last injection
Other outcomes:
Locations:
city: Botucatu
country: Brazil
facility: Galderma Investigational Center
city: Rio de Janeiro
country: Brazil
facility: Galderma Investigational Center
city: Saö Paulo
country: Brazil
facility: Galderma Investigational Center
Study officials:
affiliation: Galderma R&D
name: Clinical Scientist
role: STUDY_DIRECTOR
References: