Patients With Moderate to Severe Perioral Lines
Conditions
Brief summary
A prospective, randomized, controlled, multi-center study of the safety and effectiveness of JUVEDERM® Ultra XC injectable gel versus Belotero Balance® for perioral lines
Interventions
DEVICEJUVEDERM® Ultra XC
Up to 3.0 mLs JUVEDERM® Ultra XC injected into the mid to deep dermis (2.0 mLs for initial treatment and 1.0 mL for touch-up treatment).
DEVICEBelotero Balance®
Up to 3.0 mLs Belotero Balance® injected into the mid to deep dermis (2.0 mLs for initial treatment and 1.0 mL for touch-up treatment).
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have moderate to severe perioral lines as assessed by the Investigator using the 4-point POLSS (none, mild, moderate, and severe) * Accept the obligation not to receive any other facial procedures or treatments at any time during the study that are not study related
Exclusion criteria
* Have lip tattoos, facial hair or scars that would interfere with visualization of the lips and perioral area for the effectiveness assessments * Have dentures or any device covering all or part of the upper palate, and/or severe malocclusion, dentofacial or maxillofacial deformities, or significant asymmetry of the perioral area, as judged by the Treating Investigator * Have a history of skin cancer * Is an active smoker * Has noticeable acne scarring, active inflammation, infection, cancerous or precancerous lesion, or unhealed wound in the mouth area * Have had an active oral herpes or cold sore within 12 months * Have undergone oral surgery or other dental procedures (e.g., tooth extraction, orthodontia, or implantation) within 30 days prior to enrollment or be planning to undergo any of these procedures during the study * Have undergone cosmetic facial or perioral area procedures \[e.g., face-lift, or other surgeries which may alter the appearance of the perioral area, including tissue grafting, or tissue augmentation with silicone, fat, or other permanent fillers\] or be planning to undergo any of these procedures at any time during the study * Have undergone temporary or semi-permanent facial dermal filler injections (e.g., hyaluronic acid, calcium hydroxylapatite, L-Polylactic acid) in the lower face (below the orbital rim) within 24 months * Have received mesotherapy, or resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel, or other ablative or non-ablative procedures) within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study other than study related procedures. * Have begun use of any new over-the-counter or prescription, oral or topical, antiwrinkle products in the treatment area within 90 days prior to enrollment or be planning to begin use of such products at any time during the study. \[NOTE: Use of sunscreens and continued therapy with some cosmeceuticals (e.g., alpha hydroxyl acids, glycolic acids, retinol, or retinoic acids) is allowed if the regimen was established ≥ 90 days prior to enrollment\] * Have had epilation (e.g. laser hair removal, electrolysis, threading, etc.) in the perioral area performed within 3 months * Have received treatment with botulinum toxin of any serotype for any indication in the lower face \[below the infraorbital rims (IORs)\] within 1 year of the baseline visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least a 1 Point Improvement From Baseline on the Perioral Lines Severity Scale (POLSS) | Baseline, Month 6 | The investigator evaluated the severity of the participant's upper and low lip at Baseline (Pre-treatment) to Month 6 using the 4-point POLSS where None=No lines, Mild=Few, shallow lines, Moderate=Some, moderate lines or Severe=Many, deep lines or crevices. The percentage of participants with at least a 1 Point Improvement is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Assessed Procedural and Post-Procedural Pain Levels | During injection, immediately following injection, 15, 30, and 45 min post-injection | The participant assessed procedural and post-procedural pain using an 11-point scale where: 0=no pain to 10=worst pain imaginable. |
| Subject's Global Assessment of Change in Appearance of Perioral Lines | Baseline, Days 7, 14, Days 7, 14 after touch-up, Months 1, 3 and 6 | The participant evaluated the change in the appearance of their perioral lines (the lines that radiate outward from the edges of the upper and lower lips) using a 7-point scale where: 1 = Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; 7=Very much worse. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| JUVEDERM® Ultra XC JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable). | 68 |
| Belotero Balance® Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable). | 68 |
| Total | 136 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Personal Reasons | 1 | 2 |
| Overall Study | Protocol Violation | 1 | 1 |
Baseline characteristics
| Characteristic | JUVEDERM® Ultra XC | Belotero Balance® | Total |
|---|---|---|---|
| Age, Continuous | 58.2 years STANDARD_DEVIATION 7.5 | 58.2 years STANDARD_DEVIATION 9.26 | 58.2 years STANDARD_DEVIATION 8.39 |
| Sex: Female, Male Female | 67 Participants | 68 Participants | 135 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 68 | 10 / 68 |
| serious Total, serious adverse events | 0 / 68 | 0 / 68 |
Outcome results
Primary
Percentage of Participants With at Least a 1 Point Improvement From Baseline on the Perioral Lines Severity Scale (POLSS)
The investigator evaluated the severity of the participant's upper and low lip at Baseline (Pre-treatment) to Month 6 using the 4-point POLSS where None=No lines, Mild=Few, shallow lines, Moderate=Some, moderate lines or Severe=Many, deep lines or crevices. The percentage of participants with at least a 1 Point Improvement is reported.
Time frame: Baseline, Month 6
Population: Participants from the Intent-to-treat population, all randomized treated participants, with data available for analysis at Month 6.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JUVEDERM® Ultra XC | Percentage of Participants With at Least a 1 Point Improvement From Baseline on the Perioral Lines Severity Scale (POLSS) | 87 percentage of participants |
| Belotero Balance® | Percentage of Participants With at Least a 1 Point Improvement From Baseline on the Perioral Lines Severity Scale (POLSS) | 72 percentage of participants |
Secondary
Participant Assessed Procedural and Post-Procedural Pain Levels
The participant assessed procedural and post-procedural pain using an 11-point scale where: 0=no pain to 10=worst pain imaginable.
Time frame: During injection, immediately following injection, 15, 30, and 45 min post-injection
Population: Intent-to-treat population included all randomized and treated participants.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| JUVEDERM® Ultra XC | Participant Assessed Procedural and Post-Procedural Pain Levels | 30 minutes following Injection | 0.1 units on a scale |
| JUVEDERM® Ultra XC | Participant Assessed Procedural and Post-Procedural Pain Levels | During Injection | 2.9 units on a scale |
| JUVEDERM® Ultra XC | Participant Assessed Procedural and Post-Procedural Pain Levels | 45 minutes following Injection | 0.0 units on a scale |
| JUVEDERM® Ultra XC | Participant Assessed Procedural and Post-Procedural Pain Levels | Immediately following Injection | 0.8 units on a scale |
| JUVEDERM® Ultra XC | Participant Assessed Procedural and Post-Procedural Pain Levels | 15 minutes following Injection | 0.1 units on a scale |
| Belotero Balance® | Participant Assessed Procedural and Post-Procedural Pain Levels | Immediately following Injection | 1.8 units on a scale |
| Belotero Balance® | Participant Assessed Procedural and Post-Procedural Pain Levels | 15 minutes following Injection | 0.5 units on a scale |
| Belotero Balance® | Participant Assessed Procedural and Post-Procedural Pain Levels | 30 minutes following Injection | 0.3 units on a scale |
| Belotero Balance® | Participant Assessed Procedural and Post-Procedural Pain Levels | 45 minutes following Injection | 0.2 units on a scale |
| Belotero Balance® | Participant Assessed Procedural and Post-Procedural Pain Levels | During Injection | 4.4 units on a scale |
Secondary
Subject's Global Assessment of Change in Appearance of Perioral Lines
The participant evaluated the change in the appearance of their perioral lines (the lines that radiate outward from the edges of the upper and lower lips) using a 7-point scale where: 1 = Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; 7=Very much worse.
Time frame: Baseline, Days 7, 14, Days 7, 14 after touch-up, Months 1, 3 and 6
Population: Participants from the Intent-to-treat population, all randomized treated participants, with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| JUVEDERM® Ultra XC | Subject's Global Assessment of Change in Appearance of Perioral Lines | Day 7 after Touch-up (n=30,42) | 1.6 units on a scale |
| JUVEDERM® Ultra XC | Subject's Global Assessment of Change in Appearance of Perioral Lines | Day 14 after Touch-up (n=32,40) | 1.8 units on a scale |
| JUVEDERM® Ultra XC | Subject's Global Assessment of Change in Appearance of Perioral Lines | Month 3 (n=68,65) | 1.8 units on a scale |
| JUVEDERM® Ultra XC | Subject's Global Assessment of Change in Appearance of Perioral Lines | Month 6 (n=67,65) | 1.9 units on a scale |
| JUVEDERM® Ultra XC | Subject's Global Assessment of Change in Appearance of Perioral Lines | Day 7 | 1.8 units on a scale |
| JUVEDERM® Ultra XC | Subject's Global Assessment of Change in Appearance of Perioral Lines | Day 14 or Touch-up (n=66,67) | 1.7 units on a scale |
| JUVEDERM® Ultra XC | Subject's Global Assessment of Change in Appearance of Perioral Lines | Month 1 (n=66,67) | 1.7 units on a scale |
| Belotero Balance® | Subject's Global Assessment of Change in Appearance of Perioral Lines | Day 14 after Touch-up (n=32,40) | 1.8 units on a scale |
| Belotero Balance® | Subject's Global Assessment of Change in Appearance of Perioral Lines | Day 7 after Touch-up (n=30,42) | 1.8 units on a scale |
| Belotero Balance® | Subject's Global Assessment of Change in Appearance of Perioral Lines | Day 7 | 2.1 units on a scale |
| Belotero Balance® | Subject's Global Assessment of Change in Appearance of Perioral Lines | Month 1 (n=66,67) | 2.0 units on a scale |
| Belotero Balance® | Subject's Global Assessment of Change in Appearance of Perioral Lines | Month 6 (n=67,65) | 2.6 units on a scale |
| Belotero Balance® | Subject's Global Assessment of Change in Appearance of Perioral Lines | Month 3 (n=68,65) | 2.2 units on a scale |
| Belotero Balance® | Subject's Global Assessment of Change in Appearance of Perioral Lines | Day 14 or Touch-up (n=66,67) | 2.0 units on a scale |