Trial Outcomes & Findings for Study of BOTOX and JUVEDERM for Treatment of Moderate to Severe Facial Wrinkles and Folds (NCT NCT01269801)
NCT ID: NCT01269801
Last Updated: 2014-12-16
Results Overview
Assessments at Visits 3,5,6+7 (weeks 4,8,12,24) include: -Physician Global Aesthetic Improvement Scale (PGAIS). Ratings include no change, improved, much improved, very much improved. Number of subjects with improvement score for the 5 point PGAIS from baseline to Visit 7. -Objective Observer Global Aesthetic Improvement Scale Number of subjects with improvement score for the from baseline to Visit 7. Ratings include no change, some improvement, definite improvement, substantial improvement, and complete improvement.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
156 participants
Primary outcome timeframe
Week 4, 8, 12, 24
Results posted on
2014-12-16
Participant Flow
Subjects were randomized to two groups: Juvederm first, then Botox (Juvederm group) or Botox first, then Juvederm (Botox group). For the Juvederm group, Day 1 involved juvederm treatment. Week 4 involved botox administration. For the Botox group, Day 1 involved botox treatment. Week 4 involved juvederm administration.
Participant milestones
| Measure |
JUVÉDERM
JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel
Juvederm group will initially receive JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions at Day 1.
At Week 4, patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment.
|
Botox Cosmetic
Botox group will initially receive BOTOX® Cosmetic injections to the affected facial regions at Day 1.
At Week 4, patients who initially received BOTOX® Cosmetic treatment will be crossed over to receive JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
80
|
|
Overall Study
COMPLETED
|
74
|
77
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of BOTOX and JUVEDERM for Treatment of Moderate to Severe Facial Wrinkles and Folds
Baseline characteristics by cohort
| Measure |
Botox Cosmetic
n=80 Participants
Botox group will initially receive BOTOX® Cosmetic injections to the affected facial regions at Day 1.
At Week 4, patients who initially received BOTOX® Cosmetic treatment will be crossed over to receive JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel treatment.
|
JUVÉDERM
n=74 Participants
JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel
Juvederm group will initially receive JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions at Day 1.
At Week 4, patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment.
|
Total
n=154 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
80 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
49.83 years
STANDARD_DEVIATION 7.42 • n=5 Participants
|
51.12 years
STANDARD_DEVIATION 7.78 • n=7 Participants
|
50.54 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 4, 8, 12, 24Population: Analysis is based on the randomization group to account for the order in which the products were administered.
Assessments at Visits 3,5,6+7 (weeks 4,8,12,24) include: -Physician Global Aesthetic Improvement Scale (PGAIS). Ratings include no change, improved, much improved, very much improved. Number of subjects with improvement score for the 5 point PGAIS from baseline to Visit 7. -Objective Observer Global Aesthetic Improvement Scale Number of subjects with improvement score for the from baseline to Visit 7. Ratings include no change, some improvement, definite improvement, substantial improvement, and complete improvement.
Outcome measures
| Measure |
Botox Cosmetic
n=77 Participants
Botox group will initially receive BOTOX® Cosmetic injections to the affected facial regions at Day 1.
At Week 4, patients who initially received BOTOX® Cosmetic treatment will be crossed over to receive JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel treatment.
|
JUVÉDERM
n=74 Participants
JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel
Juvederm group will initially receive JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions at Day 1.
At Week 4, patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment.
|
|---|---|---|
|
Efficacy
PGAIS Week 24
|
77 participantes rated improved and higher
|
74 participantes rated improved and higher
|
|
Efficacy
Objective Observer global assessment Week 24
|
73 participantes rated improved and higher
|
72 participantes rated improved and higher
|
|
Efficacy
PGAIS Week 12
|
77 participantes rated improved and higher
|
74 participantes rated improved and higher
|
|
Efficacy
Objective Observer global assessment Week 12
|
77 participantes rated improved and higher
|
74 participantes rated improved and higher
|
|
Efficacy
PGAIS Week 8
|
78 participantes rated improved and higher
|
73 participantes rated improved and higher
|
|
Efficacy
Objective Observer global assessment Week 8
|
78 participantes rated improved and higher
|
73 participantes rated improved and higher
|
|
Efficacy
PGAIS Week 4
|
75 participantes rated improved and higher
|
74 participantes rated improved and higher
|
|
Efficacy
Objective Observer global assessment Week 4
|
72 participantes rated improved and higher
|
74 participantes rated improved and higher
|
Adverse Events
Botox Cosmetic
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
JUVÉDERM
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Botox Cosmetic
n=154 participants at risk
Botox group will initially receive BOTOX® Cosmetic injections to the affected facial regions at Day 1.
At Week 4, patients who initially received BOTOX® Cosmetic treatment will be crossed over to receive JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel treatment.
|
JUVÉDERM
n=152 participants at risk
JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel
Juvederm group will initially receive JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions at Day 1.
At Week 4, patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment.
|
|---|---|---|
|
Vascular disorders
death due to hypertensive cardiovascular disease
|
0.65%
1/154 • Number of events 1 • Week 4, 8, 12, 24
Adverse Events assessed based on treatment received before the adverse event onset.
|
0.00%
0/152 • Week 4, 8, 12, 24
Adverse Events assessed based on treatment received before the adverse event onset.
|
Other adverse events
| Measure |
Botox Cosmetic
n=154 participants at risk
Botox group will initially receive BOTOX® Cosmetic injections to the affected facial regions at Day 1.
At Week 4, patients who initially received BOTOX® Cosmetic treatment will be crossed over to receive JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel treatment.
|
JUVÉDERM
n=152 participants at risk
JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel
Juvederm group will initially receive JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions at Day 1.
At Week 4, patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
(Contusion) Bruising
|
0.65%
1/154 • Number of events 1 • Week 4, 8, 12, 24
Adverse Events assessed based on treatment received before the adverse event onset.
|
12.5%
19/152 • Number of events 19 • Week 4, 8, 12, 24
Adverse Events assessed based on treatment received before the adverse event onset.
|
|
Nervous system disorders
Facial Paresis
|
5.2%
8/154 • Number of events 8 • Week 4, 8, 12, 24
Adverse Events assessed based on treatment received before the adverse event onset.
|
0.00%
0/152 • Week 4, 8, 12, 24
Adverse Events assessed based on treatment received before the adverse event onset.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place