Trial Outcomes & Findings for Safety/Efficacy Study of Restylane® in Lip Augmentation (NCT NCT00935272)

Last Updated: 2012-01-30

Results Overview

Assessment of lip fullness augmentation after treatment with Restylane, as compared to no treatment, at week 8 as compared to baseline assessment. Response was determined by at least one grade improvement from baseline in the upper and lower lips using the Medicis Lip Fullness Scale (MLFS). The MLFS is a 5 number scale with grading: (1) Very Thin, (2) Thin (3) Medium (4) Full and (5)Very Full.

Recruitment status

COMPLETED

Study phase

Target enrollment

180 participants

Primary outcome timeframe

Baseline and at 8 weeks

Results posted on

2012-01-30

Participant Flow

Date of first enrollment: July 20, 2009 Date last subject completed: June 1, 2010 180 subjects enrolled from 12 investigational centers

Subjects with Fitzpatrick Skin Types I, II or III (lighter skin types) needed both lips to be assessed as very thin or thin to meet enrollment criteria. Subjects with Fitzpatrick Skin Types IV, V or VI (darker skin types) need at least one lip to be assessed as very thin or thin to meet enrollment criteria.

Participant milestones

Participant milestones
Measure	Treatment With Restylane Restylane is composed of a clear, colorless and transparent gel in sterile 1.0 mL syringes. It is supplied with a sterilized 30G x ½ inch needle. The number of syringes used depends on the amount needed to achieve optimal lip augmentation. Optimal lip augmentation is defined as the best possible aesthetic result that can be obtained. Treatment will occur on day 1, with an optional 2 week touch-up at the investigator's and patient's discretion.	No Treatment Subjects who received no treatment, for comparison purposes, for the primary efficacy and safety analysis
Overall Study STARTED	135	45
Overall Study COMPLETED	116	39
Overall Study NOT COMPLETED	19	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment With Restylane Restylane is composed of a clear, colorless and transparent gel in sterile 1.0 mL syringes. It is supplied with a sterilized 30G x ½ inch needle. The number of syringes used depends on the amount needed to achieve optimal lip augmentation. Optimal lip augmentation is defined as the best possible aesthetic result that can be obtained. Treatment will occur on day 1, with an optional 2 week touch-up at the investigator's and patient's discretion.	No Treatment Subjects who received no treatment, for comparison purposes, for the primary efficacy and safety analysis
Overall Study Lost to Follow-up	10	3
Overall Study Withdrawal by Subject	8	2
Overall Study Physician Decision	1	0
Overall Study Protocol Violation	0	1

Baseline Characteristics

Safety/Efficacy Study of Restylane® in Lip Augmentation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment With Restylane n=135 Participants Restylane is composed of a clear, colorless and transparent gel in sterile 1.0 mL syringes. It is supplied with a sterilized 30G x ½ inch needle. The number of syringes used depends on the amount needed to achieve optimal lip augmentation. Optimal lip augmentation is defined as the best possible aesthetic result that can be obtained. Treatment will occur on day 1, with an optional 2 week touch-up at the investigator's and patient's discretion.	No Treatment n=45 Participants Subjects who received no treatment, for comparison purposes, for the primary efficacy and safety analysis	Total n=180 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	133 Participants n=93 Participants	44 Participants n=4 Participants	177 Participants n=27 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Age Continuous	47.8 years STANDARD_DEVIATION 10.5 • n=93 Participants	47.2 years STANDARD_DEVIATION 10.9 • n=4 Participants	47.6 years STANDARD_DEVIATION 10.6 • n=27 Participants
Sex: Female, Male Female	134 Participants n=93 Participants	45 Participants n=4 Participants	179 Participants n=27 Participants
Sex: Female, Male Male	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Region of Enrollment United States	135 participants n=93 Participants	45 participants n=4 Participants	180 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and at 8 weeks

Population: Analysis was ITT; Sample size based upon a one-sided Fisher's Exact test with alpha = 0.05; Subjects with a missing Blinded Evaluator assessment as Week 8 were imputed using the hot deck method

Outcome measures

Outcome measures
Measure	Treatment With Restylane n=135 Participants Restylane is composed of a clear, colorless and transparent gel in sterile 1.0 mL syringes. It is supplied with a sterilized 30G x ½ inch needle. The number of syringes used depends on the amount needed to achieve optimal lip augmentation. Optimal lip augmentation is defined as the best possible aesthetic result that can be obtained. Treatment will occur on day 1, with an optional 2 week touch-up at the investigator's and patient's discretion.	No Treatment n=45 Participants Subjects who received no treatment, for comparison purposes, for the primary efficacy and safety analysis
Percentage of Participants With Response	92.6 Percentage of Participants Interval 86.8 to 96.4	28.9 Percentage of Participants Interval 16.4 to 44.3

SECONDARY outcome

Timeframe: Baseline and at weeks 12, 16, 20 and 24

Population: For this secondary objective, the pool of participants analyzed was based on 135 from the Intent to Treat population. However the analysis was done with the number of subjects with non-missing data. This number varied for each timepoint.

Assessment of lip fullness augmentation after treatment with Restylane, as compared to no treatment, at post-baseline time points as compared to baseline assessment. Response was determined by at least one grade improvement from baseline in the upper and lower lips using the Medicis Lip Fullness Scale (MLFS). The MLFS is a 5 number scale with grading: (1) Very Thin, (2) Thin (3) Medium (4) Full and (5)Very Full.

Outcome measures

Outcome measures
Measure	Treatment With Restylane n=135 Participants Restylane is composed of a clear, colorless and transparent gel in sterile 1.0 mL syringes. It is supplied with a sterilized 30G x ½ inch needle. The number of syringes used depends on the amount needed to achieve optimal lip augmentation. Optimal lip augmentation is defined as the best possible aesthetic result that can be obtained. Treatment will occur on day 1, with an optional 2 week touch-up at the investigator's and patient's discretion.	No Treatment n=45 Participants Subjects who received no treatment, for comparison purposes, for the primary efficacy and safety analysis
Percentage of Participants With a Response Week 12	90.1 Percent of responders Interval 83.3 to 94.8	36.8 Percent of responders Interval 21.8 to 54.0
Percentage of Participants With a Response Week 16	84.2 Percent of responders Interval 76.4 to 90.2	35.9 Percent of responders Interval 21.2 to 52.8
Percentage of Participants With a Response Week 20	75.0 Percent of responders Interval 66.1 to 82.6	33.3 Percent of responders Interval 19.1 to 50.2
Percentage of Participants With a Response Week 24	69.6 Percent of responders Interval 60.3 to 77.8	36.8 Percent of responders Interval 21.8 to 54.0

Adverse Events

Treatment With Restylane

Serious events: 4 serious events

Other events: 149 other events

Deaths: 0 deaths

No Treatment

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Second Treatment

Serious events: 0 serious events

Other events: 60 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment With Restylane n=172 participants at risk；n=135 participants at risk Safety included post treatment assessment, and assessments at each visit throughout the study.	No Treatment n=45 participants at risk Safety included post treatment assessment, and assessments at each visit throughout the study.	Second Treatment n=93 participants at risk At Week 24, subjects who were initially randomized to treatment were offered an optional second treatment with Restylane. In addition those randomized to non-treatment were offered their first treatment of Restylane at week 24. The safety from this set was followed to one month after the treatment.
Infections and infestations Acute Diverticulitis	0.74% 1/135 • Number of events 1	0.00% 0/45	0.00% 0/93
Nervous system disorders Transient Ischemic Attack	0.74% 1/135 • Number of events 1	0.00% 0/45	0.00% 0/93
Musculoskeletal and connective tissue disorders Lumbar Spinal Stenosis	0.74% 1/135 • Number of events 1	0.00% 0/45	0.00% 0/93
Infections and infestations Streptococcus Pneumonia	0.74% 1/135 • Number of events 1	0.00% 0/45	0.00% 0/93
Pregnancy, puerperium and perinatal conditions Pregnancy	0.00% 0/135	2.2% 1/45 • Number of events 1	0.00% 0/93

Other adverse events

Other adverse events
Measure	Treatment With Restylane n=172 participants at risk；n=135 participants at risk Safety included post treatment assessment, and assessments at each visit throughout the study.	No Treatment n=45 participants at risk Safety included post treatment assessment, and assessments at each visit throughout the study.	Second Treatment n=93 participants at risk At Week 24, subjects who were initially randomized to treatment were offered an optional second treatment with Restylane. In addition those randomized to non-treatment were offered their first treatment of Restylane at week 24. The safety from this set was followed to one month after the treatment.
General disorders Pain	20.9% 36/172 • Number of events 97	2.2% 1/45 • Number of events 1	20.4% 19/93 • Number of events 51
General disorders Swelling	58.1% 100/172 • Number of events 224	0.00% 0/45	55.9% 52/93 • Number of events 103
General disorders Tenderness	22.1% 38/172 • Number of events 69	0.00% 0/45	17.2% 16/93 • Number of events 29
Infections and infestations Nasopharyngitis	5.2% 9/172 • Number of events 9	4.4% 2/45 • Number of events 3	2.2% 2/93 • Number of events 2
Injury, poisoning and procedural complications Contusion	44.2% 76/172 • Number of events 131	0.00% 0/45	28.0% 26/93 • Number of events 41
Nervous system disorders Headache	7.0% 12/172 • Number of events 17	4.4% 2/45 • Number of events 3	3.2% 3/93 • Number of events 3
Skin and subcutaneous tissue disorders Erythema	16.9% 29/172 • Number of events 57	0.00% 0/45	10.8% 10/93 • Number of events 19
Skin and subcutaneous tissue disorders Skin Exfoliation	8.1% 14/172 • Number of events 21	0.00% 0/45	2.2% 2/93 • Number of events 2

Additional Information

Heather M Corey

Medicis Global Services

Phone: 480-291-5981

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60