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OpenTrials
Completed

NCT Number: NCT01029535

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

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.

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Key information

Conditions

Mid-face Volume Deficiency

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sydney, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Cross-linked hyaluronic acid gel

Device

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

Other names: Juvederm® VOLUMA™

Primary outcomes

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

    Time frame: Baseline, 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.

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

    Time frame: Baseline, 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.

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

    Time frame: Baseline, 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.

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

    Time frame: Baseline, 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.

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

    Time frame: Baseline, 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.

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

    Time frame: Baseline, 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.

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

    Time frame: Baseline, Week 8, 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.

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

    Time frame: Baseline, Week 8, 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.

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

    Time frame: Baseline, Week 8, 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.

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

    Time frame: Baseline, Week 8, 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.

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

    Time frame: Baseline, Week 8, 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.

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

    Time frame: Baseline, Week 8, 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.

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

    Time frame: Baseline, Week 8, 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.

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

    Time frame: Baseline, Week 8, 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.

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

    Time frame: Baseline, Week 8, 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.

Secondary outcomes

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

    Time frame: Baseline, Weeks 4, 8, 52, 78 and 104

    The physician assessed the left side and the right side of the participant's face for severity of nasolabial folds using the 5-point WAS where: 0=no wrinkle to 4=very deep wrinkle.

  2. Change From Baseline in the MFVDS Score

    Time frame: Baseline, Weeks 4, 8, 52, 78 and 104

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

  3. Physician Assessment of Global Aesthetic Improvement Score (GAIS)

    Time frame: Baseline, Weeks 4, 8, 52, 78 and 104

    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.

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

    Time frame: Baseline, Weeks 4, 8, 52, 78 and 104

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

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

    Time frame: Baseline, Weeks 4, 8, 52, 78 and 104

    The participant rated their facial age in years at Baseline and Weeks 4, 8, 52, 78 and 104. A negative change from Baseline indicates an improvement.

  6. Percentage of Participants Satisfied or Very Satisfied With the Treatment

    Time frame: Week 8

    Participants rated their satisfaction with treatment using a 5-Point Scale where: 1=very unsatisfied to 5=very satisfied.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 10, 2009
Registry last updated
Mar 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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