Trial Outcomes & Findings for Safety and Effectiveness of Juvederm(R) Ultra XC Injectable Gel for Lip Augmentation (NCT NCT01197495)

NCT ID: NCT01197495

Last Updated: 2019-04-16

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 213 participants
• Primary outcome timeframe: Baseline, Month 3
• Results posted on: 2019-04-16

Participant Flow

The modified intent-to-treat (mITT) population is presented and includes all treated subjects.

Participant milestones

Measure	Treatment Juvederm(R) Ultra XC Injectable Gel	Control No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.
Overall Study STARTED	157	56
Overall Study COMPLETED	144	49
Overall Study NOT COMPLETED	13	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Effectiveness of Juvederm(R) Ultra XC Injectable Gel for Lip Augmentation

Baseline characteristics by cohort

Measure	Treatment n=157 Participants Juvederm(R) Ultra XC Injectable Gel	Control n=56 Participants No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.	Total n=213 Participants Total of all reporting groups
Age, Continuous	48.6 Years STANDARD_DEVIATION 11.46 • n=5 Participants	49.2 Years STANDARD_DEVIATION 9.72 • n=7 Participants	48.8 Years STANDARD_DEVIATION 11.01 • n=5 Participants
Sex: Female, Male Female	150 Participants n=5 Participants	54 Participants n=7 Participants	204 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Month 3

Population: Modified Intent-to-Treat: all treated subjects with data at the designated time point

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.

Outcome measures

Measure	Treatment n=139 Participants Juvederm(R) Ultra XC Injectable Gel	Control n=46 Participants No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.
Percentage of Subjects With ≥1-Point Improvement on the Investigator Assessed 5-point Lip Fullness Scale 2 (LFS2)	79.1 Percentage of Subjects Interval 71.43 to 85.56	26.1 Percentage of Subjects Interval 14.27 to 41.13

SECONDARY outcome

Timeframe: Baseline, Month 3

Population: Subjects treated for POL at the designated time points

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).

Outcome measures

Measure	Treatment n=61 Participants Juvederm(R) Ultra XC Injectable Gel	Control No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.
Percentage of Subjects With ≥1-Point Improvement on the Perioral Line (POL) Severity Scale	47.5 Percentage of Subjects	—

SECONDARY outcome

Timeframe: Baseline, Month 3

Population: Subjects treated for OCS at the designated time points

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).

Outcome measures

Measure	Treatment n=241 Oral Commissures Juvederm(R) Ultra XC Injectable Gel	Control No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.
Percentage of Oral Commissures With ≥1-Point Improvement on the Oral Commissures Severity (OCS) Scale	47.3 Percentage of Oral Commissures	—

SECONDARY outcome

Timeframe: Baseline, Month 3

Population: Treated subjects in the Treatment group

Subjects assessed their personal treatment goal of overall lip fullness as 'achieved' or 'not achieved.'

Outcome measures

Measure	Treatment n=137 Participants Juvederm(R) Ultra XC Injectable Gel	Control No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.
Percentage of Subjects Achieving Their Personal Treatment Goal of Overall Lip Fullness	81.8 Percentage of Subjects	—

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Treatment n=142 Participants Juvederm(R) Ultra XC Injectable Gel	Control n=48 Participants No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.
Duration Effect of Treatment on Lip Fullness Month 7.5 (N=89, 29)	64.4 % of Pts Retaining ≥1-point Improvement Interval 56.51 to 72.2	63.9 % of Pts Retaining ≥1-point Improvement Interval 49.37 to 78.36
Duration Effect of Treatment on Lip Fullness Month 9 (N=75, 24)	54.1 % of Pts Retaining ≥1-point Improvement Interval 45.58 to 62.54	55.4 % of Pts Retaining ≥1-point Improvement Interval 39.97 to 70.82
Duration Effect of Treatment on Lip Fullness Month 10.5 (N=69, 19)	48.9 % of Pts Retaining ≥1-point Improvement Interval 40.29 to 57.53	45.8 % of Pts Retaining ≥1-point Improvement Interval 29.64 to 61.92
Duration Effect of Treatment on Lip Fullness Month 12 (N=51, 8)	45.1 % of Pts Retaining ≥1-point Improvement Interval 36.32 to 53.78	36.6 % of Pts Retaining ≥1-point Improvement Interval 16.02 to 57.23
Duration Effect of Treatment on Lip Fullness Month 1	93.5 % of Pts Retaining ≥1-point Improvement Interval 89.53 to 97.38	98.0 % of Pts Retaining ≥1-point Improvement Interval 94.0 to 100.0
Duration Effect of Treatment on Lip Fullness Month 3 (N=114, 37)	77.5 % of Pts Retaining ≥1-point Improvement Interval 70.78 to 84.13	77.3 % of Pts Retaining ≥1-point Improvement Interval 65.42 to 89.08
Duration Effect of Treatment on Lip Fullness Month 6 (N=99, 35)	69.1 % of Pts Retaining ≥1-point Improvement Interval 61.64 to 76.54	74.8 % of Pts Retaining ≥1-point Improvement Interval 62.34 to 87.18

Adverse Events

Onset Prior to Repeat Treatment

Serious events: 4 serious events

Other events: 63 other events

Deaths: 0 deaths

Onset After Repeat Treatment

Serious events: 2 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Measure	Onset Prior to Repeat Treatment n=208 participants at risk Juvederm(R) Ultra XC Injectable Gel	Onset After Repeat Treatment n=114 participants at risk Juvederm(R) Ultra XC Injectable Gel
Congenital, familial and genetic disorders Development Hip Dysplasia	0.48% 1/208 208 subjects includes subjects who received initial treatment in both groups (157 in the treatment group and 51 in the control group). 114 subjects includes subjects who had repeat treatment from both treatment groups.	0.00% 0/114 208 subjects includes subjects who received initial treatment in both groups (157 in the treatment group and 51 in the control group). 114 subjects includes subjects who had repeat treatment from both treatment groups.
Immune system disorders Drug Hypersensitivity	0.48% 1/208 208 subjects includes subjects who received initial treatment in both groups (157 in the treatment group and 51 in the control group). 114 subjects includes subjects who had repeat treatment from both treatment groups.	0.00% 0/114 208 subjects includes subjects who received initial treatment in both groups (157 in the treatment group and 51 in the control group). 114 subjects includes subjects who had repeat treatment from both treatment groups.
Metabolism and nutrition disorders Diabetes Mellitus	0.48% 1/208 208 subjects includes subjects who received initial treatment in both groups (157 in the treatment group and 51 in the control group). 114 subjects includes subjects who had repeat treatment from both treatment groups.	0.00% 0/114 208 subjects includes subjects who received initial treatment in both groups (157 in the treatment group and 51 in the control group). 114 subjects includes subjects who had repeat treatment from both treatment groups.
Skin and subcutaneous tissue disorders Angioedema	0.48% 1/208 208 subjects includes subjects who received initial treatment in both groups (157 in the treatment group and 51 in the control group). 114 subjects includes subjects who had repeat treatment from both treatment groups.	0.00% 0/114 208 subjects includes subjects who received initial treatment in both groups (157 in the treatment group and 51 in the control group). 114 subjects includes subjects who had repeat treatment from both treatment groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma	0.00% 0/208 208 subjects includes subjects who received initial treatment in both groups (157 in the treatment group and 51 in the control group). 114 subjects includes subjects who had repeat treatment from both treatment groups.	0.88% 1/114 208 subjects includes subjects who received initial treatment in both groups (157 in the treatment group and 51 in the control group). 114 subjects includes subjects who had repeat treatment from both treatment groups.
Pregnancy, puerperium and perinatal conditions Premature Baby	0.00% 0/208 208 subjects includes subjects who received initial treatment in both groups (157 in the treatment group and 51 in the control group). 114 subjects includes subjects who had repeat treatment from both treatment groups.	0.88% 1/114 208 subjects includes subjects who received initial treatment in both groups (157 in the treatment group and 51 in the control group). 114 subjects includes subjects who had repeat treatment from both treatment groups.

Other adverse events

Measure	Onset Prior to Repeat Treatment n=208 participants at risk Juvederm(R) Ultra XC Injectable Gel	Onset After Repeat Treatment n=114 participants at risk Juvederm(R) Ultra XC Injectable Gel
General disorders Injection Site Mass	15.9% 33/208 208 subjects includes subjects who received initial treatment in both groups (157 in the treatment group and 51 in the control group). 114 subjects includes subjects who had repeat treatment from both treatment groups.	9.6% 11/114 208 subjects includes subjects who received initial treatment in both groups (157 in the treatment group and 51 in the control group). 114 subjects includes subjects who had repeat treatment from both treatment groups.
General disorders Injection Site Induration	10.1% 21/208 208 subjects includes subjects who received initial treatment in both groups (157 in the treatment group and 51 in the control group). 114 subjects includes subjects who had repeat treatment from both treatment groups.	9.6% 11/114 208 subjects includes subjects who received initial treatment in both groups (157 in the treatment group and 51 in the control group). 114 subjects includes subjects who had repeat treatment from both treatment groups.
General disorders Injection Site Pain	4.3% 9/208 208 subjects includes subjects who received initial treatment in both groups (157 in the treatment group and 51 in the control group). 114 subjects includes subjects who had repeat treatment from both treatment groups.	5.3% 6/114 208 subjects includes subjects who received initial treatment in both groups (157 in the treatment group and 51 in the control group). 114 subjects includes subjects who had repeat treatment from both treatment groups.

Additional Information

Allergan Inc.,

Allergan, Inc

Email: clinicaltrials@allergan.com

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 public release and can embargo communications regarding trial results for a period that is less than or equal to 90 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