Pan Facial Volume Restoration

NCT01545557 | Completed Results

• 1 other identifier: RD.03.CIP.29090
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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%.

Conditions

Volume Loss (Soft Tissue Ptosis or Atrophy )

Keywords

Volume loss

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Volume Loss Assessment

  Overall loss of volume on full face was graded on a volume loss scale (VLS) of 0 to 3 by the investigator as follow: 0= normal, 1= evidence of early soft tissue ptosis or atrophy slightly visible, 2=visible depression or descent, 3= severe depression or atrophy. Last injections were given either at baseline or touch-up injections (if needed) on previously injected areas at 3 Weeks after baseline.

  Baseline and 18 Months after last injection

Secondary Outcomes (4)

• Percentage of Participants Satisfied or Very Satisfied at 3 Weeks After Last Injection

  At 3 Weeks after last injection

• Percentage of Investigators Satisfied With the Use of Study Hyaluronic Acid Dermal Filler

  Baseline up to 18 Months after last injection

• Number of Participants With Adverse Events (AEs)

  Baseline up to 18 Months after last injection

• Percentage of Participants Satisfied or Very Satisfied at 18 Months After Last Injection

  At 18 Months after last injection

Study Arms (1)

Hyaluronic acid dermal filler

EXPERIMENTAL

One Emervel Volume injection at baseline and touch up injections 3 weeks after if needed

Device: Hyaluronic acid dermal filler gel

Interventions

Hyaluronic acid dermal filler gel DEVICE

1 Emervel Volume injection per indication and 1 touch-up injection if necessary

Also known as: Study filler is Emervel Volume Lidocaine.

Hyaluronic acid dermal filler

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (3)

Galderma Investigational Center

Botucatu, Brazil

Location

Galderma Investigational Center

Rio de Janeiro, Brazil

Location

Galderma Investigational Center

Saö Paulo, Brazil

Location

MeSH Terms

Conditions

Atrophy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical project manager
• Organization: Galderma

aestheticclinicaltrials@galderma.com

817-961-5655

Study Officials

• Clinical Scientist

  Galderma R&D

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2012
• First Posted: March 6, 2012
• Study Start: February 21, 2012
• Primary Completion: March 3, 2014
• Study Completion: March 3, 2014
• Last Updated: March 1, 2023
• Results First Posted: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (3)