Trial Outcomes & Findings for Safety and Efficacy of Juvederm® VOLUMA™ for Correction of Mid-face Volume Deficiency (NCT NCT01029535)
NCT ID: NCT01029535
Last Updated: 2016-03-09
Results Overview
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.
COMPLETED
NA
103 participants
Baseline, Week 4
2016-03-09
Participant Flow
Participant milestones
| Measure |
Juvederm® VOLUMA™
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.
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|---|---|
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Overall Study
STARTED
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103
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|
Overall Study
COMPLETED
|
72
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Overall Study
NOT COMPLETED
|
31
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Reasons for withdrawal
| Measure |
Juvederm® VOLUMA™
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.
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|---|---|
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Overall Study
Lost to Follow-up
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24
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Overall Study
Protocol Violation
|
2
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Overall Study
Participant Withdrew Consent
|
2
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Overall Study
Adverse Event
|
1
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|
Overall Study
Use of Another Treatment
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1
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Overall Study
Death
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1
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Baseline Characteristics
Safety and Efficacy of Juvederm® VOLUMA™ for Correction of Mid-face Volume Deficiency
Baseline characteristics by cohort
| Measure |
Juvederm® VOLUMA™
n=103 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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103 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
|
Age, Continuous
|
46.7 years
n=5 Participants
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|
Sex: Female, Male
Female
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83 Participants
n=5 Participants
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Sex: Female, Male
Male
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20 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline, Week 4Population: Participants from the intent-to-treat (ITT) population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.
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.
Outcome measures
| Measure |
Juvederm® VOLUMA™
n=102 Participants
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.
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|---|---|
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Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at Week 4
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97.06 percentage of participants
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PRIMARY outcome
Timeframe: Baseline, Week 8Population: Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.
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.
Outcome measures
| Measure |
Juvederm® VOLUMA™
n=99 Participants
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.
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|---|---|
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Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at Week 8
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97.98 percentage of participants
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PRIMARY outcome
Timeframe: Baseline, Week 4Population: Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.
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.
Outcome measures
| Measure |
Juvederm® VOLUMA™
n=102 Participants
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.
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|---|---|
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Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician's Global Aesthetic Improvement Scale (GAIS) at Week 4
|
100 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.
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.
Outcome measures
| Measure |
Juvederm® VOLUMA™
n=99 Participants
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.
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|---|---|
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Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician's Global Aesthetic Improvement Scale (GAIS) at Week 8
|
100 percentage of particpants
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PRIMARY outcome
Timeframe: Baseline, Week 4Population: ITT population included all enrolled participants who received at least one application of VOLUMA™.
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.
Outcome measures
| Measure |
Juvederm® VOLUMA™
n=103 Participants
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.
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|---|---|
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Percentage of Participants a ≥1 Point Improvement From Baseline in the Physician's Mid-face Volume Deficit Scale (MFVDS) at Week 4
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92.23 percentage of particpants
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PRIMARY outcome
Timeframe: Baseline, Week 8Population: Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.
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.
Outcome measures
| Measure |
Juvederm® VOLUMA™
n=99 Participants
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.
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|---|---|
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Percentage of Participants a ≥ 1 Point Improvement From Baseline in the Physician's Mid-face Volume Deficit Scale (MFVDS) at Week 8
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95.96 percentage of participants
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PRIMARY outcome
Timeframe: Baseline, Week 8, Week 52Population: ITT population included all enrolled participants who received at least one application of VOLUMA™.
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.
Outcome measures
| Measure |
Juvederm® VOLUMA™
n=103 Participants
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.
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|---|---|
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Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 52
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40.8 percentage of participants
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PRIMARY outcome
Timeframe: Baseline, Week 8, Week 78Population: ITT population included all enrolled participants who received at least one application of VOLUMA™.
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.
Outcome measures
| Measure |
Juvederm® VOLUMA™
n=103 Participants
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.
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|---|---|
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Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 78
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30.1 percentage of participants
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PRIMARY outcome
Timeframe: Baseline, Week 8, Week 104Population: ITT population included all enrolled participants who received at least one application of VOLUMA™.
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.
Outcome measures
| Measure |
Juvederm® VOLUMA™
n=103 Participants
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.
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|---|---|
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Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 104
|
38.8 percentage of participants
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PRIMARY outcome
Timeframe: Baseline, Week 8, Week 52Population: ITT population included all enrolled participants who received at least one application of VOLUMA™.
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.
Outcome measures
| Measure |
Juvederm® VOLUMA™
n=103 Participants
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.
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|---|---|
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Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 52
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41.7 percentage of participants
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PRIMARY outcome
Timeframe: Baseline, Week 8, Week 78Population: ITT population included all enrolled participants who received at least one application of VOLUMA™.
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.
Outcome measures
| Measure |
Juvederm® VOLUMA™
n=103 Participants
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.
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|---|---|
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Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 78
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36.9 percentage of participants
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PRIMARY outcome
Timeframe: Baseline, Week 8, Week 104Population: ITT population included all enrolled participants who received at least one application of VOLUMA™.
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.
Outcome measures
| Measure |
Juvederm® VOLUMA™
n=103 Participants
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.
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|---|---|
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Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 104
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36.9 percentage of participants
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PRIMARY outcome
Timeframe: Baseline, Week 8, Week 52Population: ITT population included all enrolled participants who received at least one application of VOLUMA™.
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.
Outcome measures
| Measure |
Juvederm® VOLUMA™
n=103 Participants
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.
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|---|---|
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Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 52
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32.0 percentage of participants
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PRIMARY outcome
Timeframe: Baseline, Week 8, Week 78Population: ITT population included all enrolled participants who received at least one application of VOLUMA™.
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.
Outcome measures
| Measure |
Juvederm® VOLUMA™
n=103 Participants
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.
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|---|---|
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Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 78
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28.2 percentage of participants
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PRIMARY outcome
Timeframe: Baseline, Week 8, Week 104Population: ITT population included all enrolled participants who received at least one application of VOLUMA™.
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.
Outcome measures
| Measure |
Juvederm® VOLUMA™
n=103 Participants
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.
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|---|---|
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Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 104
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29.1 percentage of participants
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SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 52, 78 and 104Population: Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.
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.
Outcome measures
| Measure |
Juvederm® VOLUMA™
n=103 Participants
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.
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|---|---|
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Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS)
Left Side Week 4 (n=103)
|
35.92 percentage of participants
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Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS)
Left Side Week 8 (n=99)
|
45.45 percentage of participants
|
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Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS)
Left Side Week 52 (n=68)
|
36.76 percentage of participants
|
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Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS)
Left Side Week 78 (n=82)
|
42.68 percentage of participants
|
|
Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS)
Left Side Week 104 (n=72)
|
48.61 percentage of participants
|
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Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS)
Right Side Week 4 (n=103)
|
34.95 percentage of participants
|
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Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS)
Right Side Week 8 (n=99)
|
43.43 percentage of participants
|
|
Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS)
Right Side Week 52 (n=68)
|
27.94 percentage of participants
|
|
Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS)
Right Side Week 78 (n=82)
|
41.46 percentage of participants
|
|
Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS)
Right Side Week 104 (n=72)
|
44.44 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 52, 78 and 104Population: Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.
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.
Outcome measures
| Measure |
Juvederm® VOLUMA™
n=103 Participants
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.
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|---|---|
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Change From Baseline in the MFVDS Score
Baseline
|
3.45 score on a scale
Standard Deviation 0.75
|
|
Change From Baseline in the MFVDS Score
Change from Baseline at Week 4
|
1.58 score on a scale
Standard Deviation 0.83
|
|
Change From Baseline in the MFVDS Score
Change from Baseline at Week 8 (n=99)
|
2.03 score on a scale
Standard Deviation 0.91
|
|
Change From Baseline in the MFVDS Score
Change from Baseline at Week 52 (n=68)
|
1.68 score on a scale
Standard Deviation 0.95
|
|
Change From Baseline in the MFVDS Score
Change from Baseline at Week 78 (n=82)
|
1.44 score on a scale
Standard Deviation 1.04
|
|
Change From Baseline in the MFVDS Score
Change from Baseline at Week 104 (n=72)
|
1.72 score on a scale
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 52, 78 and 104Population: Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.
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.
Outcome measures
| Measure |
Juvederm® VOLUMA™
n=103 Participants
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.
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|---|---|
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Physician Assessment of Global Aesthetic Improvement Score (GAIS)
Week 4 (n=102)
|
1.35 score on a scale
Standard Deviation 0.48
|
|
Physician Assessment of Global Aesthetic Improvement Score (GAIS)
Week 8 (n=99)
|
1.76 score on a scale
Standard Deviation 0.43
|
|
Physician Assessment of Global Aesthetic Improvement Score (GAIS)
Week 52 (n=68)
|
1.13 score on a scale
Standard Deviation 0.81
|
|
Physician Assessment of Global Aesthetic Improvement Score (GAIS)
Week 78 (n=82)
|
0.85 score on a scale
Standard Deviation 0.90
|
|
Physician Assessment of Global Aesthetic Improvement Score (GAIS)
Week 104 (n=72)
|
1.14 score on a scale
Standard Deviation 0.74
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 52, 78 and 104Population: Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.
The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved.
Outcome measures
| Measure |
Juvederm® VOLUMA™
n=103 Participants
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.
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|---|---|
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Subject's Assessment of Global Aesthetic Improvement Score (GAIS)
Week 4 (n=102)
|
1.31 score on a scale
Standard Deviation 0.52
|
|
Subject's Assessment of Global Aesthetic Improvement Score (GAIS)
Week 8 (n=99)
|
1.55 score on a scale
Standard Deviation 0.61
|
|
Subject's Assessment of Global Aesthetic Improvement Score (GAIS)
Week 52 (n=68)
|
1.01 score on a scale
Standard Deviation 0.86
|
|
Subject's Assessment of Global Aesthetic Improvement Score (GAIS)
Week 78 (n=82)
|
0.79 score on a scale
Standard Deviation 0.94
|
|
Subject's Assessment of Global Aesthetic Improvement Score (GAIS)
Week 104 (n=72)
|
0.97 score on a scale
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 52, 78 and 104Population: Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.
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.
Outcome measures
| Measure |
Juvederm® VOLUMA™
n=103 Participants
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.
|
|---|---|
|
Change From Baseline in the Subject's Self-Perception of Age (SPA)
Change from Baseline at Week 4 (n=101)
|
-3.03 years
Standard Deviation 3.45
|
|
Change From Baseline in the Subject's Self-Perception of Age (SPA)
Change from Baseline at Week 8 (n=98)
|
-3.74 years
Standard Deviation 3.99
|
|
Change From Baseline in the Subject's Self-Perception of Age (SPA)
Change from Baseline at Week 52 (n=68)
|
-3.15 years
Standard Deviation 4.48
|
|
Change From Baseline in the Subject's Self-Perception of Age (SPA)
Change from Baseline at Week 78 (n=82)
|
-2.88 years
Standard Deviation 4.09
|
|
Change From Baseline in the Subject's Self-Perception of Age (SPA)
Change from Baseline at Week 104 (n=72)
|
-3.85 years
Standard Deviation 4.01
|
SECONDARY outcome
Timeframe: Week 8Population: Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.
Participants rated their satisfaction with treatment using a 5-Point Scale where: 1=very unsatisfied to 5=very satisfied.
Outcome measures
| Measure |
Juvederm® VOLUMA™
n=99 Participants
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.
|
|---|---|
|
Percentage of Participants Satisfied or Very Satisfied With the Treatment
Satisfied
|
24.2 percentage of participants
|
|
Percentage of Participants Satisfied or Very Satisfied With the Treatment
Very Satisfied
|
66.7 percentage of participants
|
Adverse Events
Juvederm® VOLUMA™_Phase 1
Juvederm® VOLUMA™_Phase 2
Serious adverse events
| Measure |
Juvederm® VOLUMA™_Phase 1
n=103 participants at risk
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.
|
Juvederm® VOLUMA™_Phase 2
n=99 participants at risk
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.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Facial swelling
|
0.00%
0/103
4 Participants did not complete Week 8 of Phase 1 and were not eligible for Phase 2.
|
1.0%
1/99
4 Participants did not complete Week 8 of Phase 1 and were not eligible for Phase 2.
|
Other adverse events
| Measure |
Juvederm® VOLUMA™_Phase 1
n=103 participants at risk
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.
|
Juvederm® VOLUMA™_Phase 2
n=99 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Contusion
|
47.6%
49/103
4 Participants did not complete Week 8 of Phase 1 and were not eligible for Phase 2.
|
2.0%
2/99
4 Participants did not complete Week 8 of Phase 1 and were not eligible for Phase 2.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
10.7%
11/103
4 Participants did not complete Week 8 of Phase 1 and were not eligible for Phase 2.
|
1.0%
1/99
4 Participants did not complete Week 8 of Phase 1 and were not eligible for Phase 2.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
17.5%
18/103
4 Participants did not complete Week 8 of Phase 1 and were not eligible for Phase 2.
|
5.1%
5/99
4 Participants did not complete Week 8 of Phase 1 and were not eligible for Phase 2.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to release and can embargo communications regarding trial results for a period that is less than or equal to 120 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER