Lip Augmentation
Conditions
Brief summary
The purpose of this study is to demonstrate the safety and effectiveness of Juvederm(R) Ultra XC Injectable Gel for lip augmentation
Detailed description
All subjects were randomized to either the treatment group, Juvederm(R) Ultra XC Injectable Gel, or to the control group (no treatment). At month 3, subjects in the control group crossed over to the treatment group.
Interventions
DEVICEhyaluronic acid gel
Dosage per Investigator's discretion to obtain lip treatment gel; 1 touch-up treatment is allowed 14 to 30 days after initial treatment. Repeat treatment occurs at month 12. Subjects in the control group start with treatment at month 3. Maximum total volume per subject is 4.8 mL for initial and touch-up treatment combined.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or female, 18 years of age or older * Desire augmentation of his/her lips * Have a pre-treatment score of Minimal or Mild
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 lips and perioral area, as judged by the Treating Investigator * 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 ever undergone facial plastic surgery or received semi-permanent fillers or permanent facial implants (e.g., calcium hydroxylapatite, L-polylactic acid, PMMA, silicone, ePTFE) anywhere in the face or neck, or be planning to be implanted with any of these products at any time during the study * Have undergone temporary dermal filler treatment within 24 months prior to study entry or be planning to undergo any of these procedures at any time during the study * Have undergone cosmetic facial procedures, e.g., resurfacing (laser photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel, or other ablative or non-ablative procedures) or mesotherapy anywhere in the face or neck, or BOTOX® Cosmetic injections in the lower face (below the orbital rim), within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study * Begin use of any new over-the-counter or prescription, oral or topical, anti-wrinkle products for the lips or around the mouth within 3 months (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 hydroxy acids, glycolic acids, retinol, or retinoic acids) is allowed if the regimen was established ≥ 3months (90 days) prior to enrollment and the regimen remains unchanged during the study * Have a history of anaphylaxis, multiple severe allergies, atopy, allergy to lidocaine, hyaluronic acid products or Streptococcal protein, or be planning to undergo desensitization therapy during the term of the study * Have an active inflammation, infection, cancerous or pre-cancerous lesion, or unhealed wound in the mouth area * Be on an ongoing regimen of anti-coagulation therapy (e.g., warfarin) or have taken NSAIDS (e.g., aspirin, ibuprofen) or other substances known to increase coagulation time (e.g., herbal supplements with garlic or gingko) within 10 days of undergoing study device injections \[Study device injections may be delayed as necessary to accommodate this 10-day washout period.\] * Be pregnant, lactating, or planning to become pregnant at any time during the study * Have received investigational product within 30 days prior to study enrollment or be planning to participate in another investigation during the course of this study * Be an employee (or immediate relative of an employee) of the Treating Investigator, Evaluating Investigator, Sponsor or representative of the Sponsor * Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With ≥1-Point Improvement on the Investigator Assessed 5-point Lip Fullness Scale 2 (LFS2) | Baseline, Month 3 | Overall lip fullness is assessed by the blinded Evaluating Investigator compared to baseline using the 5-point LFS2. Scores range from 1=minimal improvement to 5=very marked improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With ≥1-Point Improvement on the Perioral Line (POL) Severity Scale | Baseline, Month 3 | Subject's upper lip perioral lines are assessed compared to baseline using the 4-point validated POL Severity Scale. Scores range from 0=None (best) to 3=Severe (worst). |
| Percentage of Oral Commissures With ≥1-Point Improvement on the Oral Commissures Severity (OCS) Scale | Baseline, Month 3 | Subject's right and left oral commissures are assessed compared to baseline using the validated OCS Scale. Scores range from 0=none (best) to 3=severe (worst). |
| Percentage of Subjects Achieving Their Personal Treatment Goal of Overall Lip Fullness | Baseline, Month 3 | Subjects assessed their personal treatment goal of overall lip fullness as 'achieved' or 'not achieved.' |
| Duration Effect of Treatment on Lip Fullness | Month 1, Month 3, Month 6, Month 7.5, Month 9, Month 10.5, Month 12 | Duration of treatment effect on lip fullness is assessed by the blinded Evaluating Investigator as ≥1-point Improvement from baseline in overall lip fullness of the eligible lip at each visit. |
Countries
United States
Participant flow
Pre-assignment details
The modified intent-to-treat (mITT) population is presented and includes all treated subjects.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Juvederm(R) Ultra XC Injectable Gel | 157 |
| Control No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3. | 56 |
| Total | 213 |
Baseline characteristics
| Characteristic | Treatment | Control | Total |
|---|---|---|---|
| Age, Continuous | 48.6 Years STANDARD_DEVIATION 11.46 | 49.2 Years STANDARD_DEVIATION 9.72 | 48.8 Years STANDARD_DEVIATION 11.01 |
| Sex: Female, Male Female | 150 Participants | 54 Participants | 204 Participants |
| Sex: Female, Male Male | 7 Participants | 2 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 63 / 208 | 28 / 114 |
| serious Total, serious adverse events | 4 / 208 | 2 / 114 |
Outcome results
Primary
Percentage of Subjects With ≥1-Point Improvement on the Investigator Assessed 5-point Lip Fullness Scale 2 (LFS2)
Overall lip fullness is assessed by the blinded Evaluating Investigator compared to baseline using the 5-point LFS2. Scores range from 1=minimal improvement to 5=very marked improvement.
Time frame: Baseline, Month 3
Population: Modified Intent-to-Treat: all treated subjects with data at the designated time point
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Percentage of Subjects With ≥1-Point Improvement on the Investigator Assessed 5-point Lip Fullness Scale 2 (LFS2) | 79.1 Percentage of Subjects |
| Control | Percentage of Subjects With ≥1-Point Improvement on the Investigator Assessed 5-point Lip Fullness Scale 2 (LFS2) | 26.1 Percentage of Subjects |
Secondary
Duration Effect of Treatment on Lip Fullness
Duration of treatment effect on lip fullness is assessed by the blinded Evaluating Investigator as ≥1-point Improvement from baseline in overall lip fullness of the eligible lip at each visit.
Time frame: Month 1, Month 3, Month 6, Month 7.5, Month 9, Month 10.5, Month 12
Population: Modified Intent-to-Treat: all treated subjects with data at the designated time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Duration Effect of Treatment on Lip Fullness | Month 6 (N=99, 35) | 69.1 % of Pts Retaining ≥1-point Improvement |
| Treatment | Duration Effect of Treatment on Lip Fullness | Month 9 (N=75, 24) | 54.1 % of Pts Retaining ≥1-point Improvement |
| Treatment | Duration Effect of Treatment on Lip Fullness | Month 3 (N=114, 37) | 77.5 % of Pts Retaining ≥1-point Improvement |
| Treatment | Duration Effect of Treatment on Lip Fullness | Month 10.5 (N=69, 19) | 48.9 % of Pts Retaining ≥1-point Improvement |
| Treatment | Duration Effect of Treatment on Lip Fullness | Month 7.5 (N=89, 29) | 64.4 % of Pts Retaining ≥1-point Improvement |
| Treatment | Duration Effect of Treatment on Lip Fullness | Month 12 (N=51, 8) | 45.1 % of Pts Retaining ≥1-point Improvement |
| Treatment | Duration Effect of Treatment on Lip Fullness | Month 1 | 93.5 % of Pts Retaining ≥1-point Improvement |
| Control | Duration Effect of Treatment on Lip Fullness | Month 12 (N=51, 8) | 36.6 % of Pts Retaining ≥1-point Improvement |
| Control | Duration Effect of Treatment on Lip Fullness | Month 1 | 98.0 % of Pts Retaining ≥1-point Improvement |
| Control | Duration Effect of Treatment on Lip Fullness | Month 3 (N=114, 37) | 77.3 % of Pts Retaining ≥1-point Improvement |
| Control | Duration Effect of Treatment on Lip Fullness | Month 6 (N=99, 35) | 74.8 % of Pts Retaining ≥1-point Improvement |
| Control | Duration Effect of Treatment on Lip Fullness | Month 7.5 (N=89, 29) | 63.9 % of Pts Retaining ≥1-point Improvement |
| Control | Duration Effect of Treatment on Lip Fullness | Month 9 (N=75, 24) | 55.4 % of Pts Retaining ≥1-point Improvement |
| Control | Duration Effect of Treatment on Lip Fullness | Month 10.5 (N=69, 19) | 45.8 % of Pts Retaining ≥1-point Improvement |
Secondary
Percentage of Oral Commissures With ≥1-Point Improvement on the Oral Commissures Severity (OCS) Scale
Subject's right and left oral commissures are assessed compared to baseline using the validated OCS Scale. Scores range from 0=none (best) to 3=severe (worst).
Time frame: Baseline, Month 3
Population: Subjects treated for OCS at the designated time points
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Percentage of Oral Commissures With ≥1-Point Improvement on the Oral Commissures Severity (OCS) Scale | 47.3 Percentage of Oral Commissures |
Secondary
Percentage of Subjects Achieving Their Personal Treatment Goal of Overall Lip Fullness
Subjects assessed their personal treatment goal of overall lip fullness as 'achieved' or 'not achieved.'
Time frame: Baseline, Month 3
Population: Treated subjects in the Treatment group
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Percentage of Subjects Achieving Their Personal Treatment Goal of Overall Lip Fullness | 81.8 Percentage of Subjects |
Secondary
Percentage of Subjects With ≥1-Point Improvement on the Perioral Line (POL) Severity Scale
Subject's upper lip perioral lines are assessed compared to baseline using the 4-point validated POL Severity Scale. Scores range from 0=None (best) to 3=Severe (worst).
Time frame: Baseline, Month 3
Population: Subjects treated for POL at the designated time points
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Percentage of Subjects With ≥1-Point Improvement on the Perioral Line (POL) Severity Scale | 47.5 Percentage of Subjects |