Safety and Efficacy of Juvederm® VOLUMA™ for Correction of Mid-face Volume Deficiency

NCT01029535 | Completed Results

• 1 other identifier: VOL-AP01
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, open-label experience study to be conducted at 6 clinical sites in Australia, with the objective to collect efficacy and safety information for Juvederm® VOLUMA™ when used for volumising the mid-face and cheek area.

Conditions

Mid-face Volume Deficiency

Outcome Measures

Primary Outcomes (15)

• Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at Week 4

  The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale where:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.

  Baseline, Week 4

• Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at Week 8

  The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.

  Baseline, Week 8

• Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician's Global Aesthetic Improvement Scale (GAIS) at Week 4

  The physician rated the participant's midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.

  Baseline, Week 4

• Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician's Global Aesthetic Improvement Scale (GAIS) at Week 8

  The physician rated the participant's midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.

  Baseline, Week 8

• Percentage of Participants a ≥1 Point Improvement From Baseline in the Physician's Mid-face Volume Deficit Scale (MFVDS) at Week 4

  The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS: 0=no facial volume loss to 5=severe volume loss.

  Baseline, Week 4

• Percentage of Participants a ≥ 1 Point Improvement From Baseline in the Physician's Mid-face Volume Deficit Scale (MFVDS) at Week 8

  The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS: 0=no facial volume loss to 5=severe volume loss.

  Baseline, Week 8

• Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 52

  The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 52, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.

  Baseline, Week 8, Week 52

• Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 78

  The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 78, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.

  Baseline, Week 8, Week 78

• Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 104

  The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 104, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.

  Baseline, Week 8, Week 104

• Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 52

  The participant rated their midface appearance compared to before treatment at Week 8 and Week 52 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.

  Baseline, Week 8, Week 52

• Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 78

  The participant rated their midface appearance compared to before treatment at Week 8 and Week 78 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.

  Baseline, Week 8, Week 78

• Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 104

  The participant rated their midface appearance compared to before treatment at Week 8 and Week 104 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.

  Baseline, Week 8, Week 104

• Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 52

  The physician rated the participant's midface appearance compared to before treatment at Week 8 and Week 52 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.

  Baseline, Week 8, Week 52

• Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 78

  The physician rated the participant's midface appearance compared to before treatment at Week 8 and Week 78 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.

  Baseline, Week 8, Week 78

• Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 104

  The physician rated the participant's midface appearance compared to before treatment at Week 8 and Week 104 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.

  Baseline, Week 8, Week 104

Secondary Outcomes (6)

• Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS)

  Baseline, Weeks 4, 8, 52, 78 and 104

• Change From Baseline in the MFVDS Score

  Baseline, Weeks 4, 8, 52, 78 and 104

• Physician Assessment of Global Aesthetic Improvement Score (GAIS)

  Baseline, Weeks 4, 8, 52, 78 and 104

• Subject's Assessment of Global Aesthetic Improvement Score (GAIS)

  Baseline, Weeks 4, 8, 52, 78 and 104

• Change From Baseline in the Subject's Self-Perception of Age (SPA)

  Baseline, Weeks 4, 8, 52, 78 and 104

Study Arms (1)

Juvederm® VOLUMA™

EXPERIMENTAL

Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.

Device: Cross-linked hyaluronic acid gel

Interventions

Cross-linked hyaluronic acid gel DEVICE

Cross-linked hyaluronic acid gel (Juvederm® VOLUMA™) up to 4 mLs injected in each side of the face.

Also known as: Juvederm® VOLUMA™

Juvederm® VOLUMA™

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects with mild to severe mid-face and cheek volume deficit due to age-related changes, who are likely to improve by at least 2 grades following treatment with the study compound, based on a study-specific scale, as assessed by the study physician

You may not qualify if:

• Subjects who have a pre-existing medical condition or who have received any treatments or procedures which may impact on the assessment of the effects of the study compound.
• Subjects with a history of allergies or other side effects to dermal fillers, lidocaine, hyaluronic acid or other component of the study compound.
• Subjects were are pregnant or breast-feeding or who are of child-bearing potential and who are not prepared to practice an adequate form of contraception during the course of the study
• Subjects with a history of alcoholism or drug abuse or dependence

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Sydney, Australia

Location

Related Publications (1)

• Callan P, Goodman GJ, Carlisle I, Liew S, Muzikants P, Scamp T, Halstead MB, Rogers JD. Efficacy and safety of a hyaluronic acid filler in subjects treated for correction of midface volume deficiency: a 24 month study. Clin Cosmet Investig Dermatol. 2013 Mar 20;6:81-9. doi: 10.2147/CCID.S40581. Print 2013.

  PMID: 23687448 BACKGROUND

Results Point of Contact

• Title: Vice President Medical Affairs,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  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: December 8, 2009
• First Posted: December 10, 2009
• Study Start: January 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 9, 2016
• Results First Posted: February 20, 2013

Record last verified: 2016-02

Locations

AU (1)