Trial Outcomes & Findings for A Study of Treatment Preference During Cheek Contouring Comparing Restylane® SubQ With and Without the Addition of Lidocaine Hydrochloride (NCT NCT01431755)
NCT ID: NCT01431755
Last Updated: 2022-09-22
Results Overview
When injection of both cheeks was completed, the subject was asked which treatment was least painful (right cheek/left cheek/both cheeks alike).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
54 participants
Primary outcome timeframe
When injection of both cheeks were completed
Results posted on
2022-09-22
Participant Flow
First subject enrolled: September 10, 2011 Last subject visit: October 19, 2012
The study has split-face design. Each subject is randomized to treatment with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek.
Participant milestones
| Measure |
Restylane SubQ/Restylane SubQ Lidocaine
The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
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|---|---|
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Overall Study
STARTED
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54
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Overall Study
COMPLETED
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49
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Overall Study
NOT COMPLETED
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5
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Treatment Preference During Cheek Contouring Comparing Restylane® SubQ With and Without the Addition of Lidocaine Hydrochloride
Baseline characteristics by cohort
| Measure |
Restylane SubQ/Restylane SubQ Lidocaine
n=54 Participants
The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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45 Participants
n=5 Participants
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Age, Categorical
>=65 years
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9 Participants
n=5 Participants
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Age, Continuous
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53 years
STANDARD_DEVIATION 13.1 • n=5 Participants
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Sex: Female, Male
Female
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51 Participants
n=5 Participants
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Sex: Female, Male
Male
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3 Participants
n=5 Participants
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Region of Enrollment
Sweden
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54 participants
n=5 Participants
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PRIMARY outcome
Timeframe: When injection of both cheeks were completedPopulation: Intention to treat. 54/54 subjects
When injection of both cheeks was completed, the subject was asked which treatment was least painful (right cheek/left cheek/both cheeks alike).
Outcome measures
| Measure |
Restylane SubQ/Restylane SubQ Lidocaine
n=54 Participants
The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
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|---|---|
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Percentage of Subjects Who Assessed Treatment With Restylane SubQ Lidocaine as Least Painful.
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100 percentage of participants
Interval 93.4 to 100.0
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SECONDARY outcome
Timeframe: 15 and 120 minutesPopulation: Intention to treat. 54/54 subjects
Pain was assessed during the first 2 hours after the initial injection of the study products using a 100 mm VAS. The endpoints of the scale were "no pain" (0 mm) and "worst possible pain" (100 mm). Pain was assessed at the time points 15, 30, 60, 90 and 120 minutes after injection.
Outcome measures
| Measure |
Restylane SubQ/Restylane SubQ Lidocaine
n=54 Participants
The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
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|---|---|
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Subject Pain Assessment by Visual Analogue Scale (VAS) 15 and 120 Minutes After Treatment.
Restylane SubQ, VAS at 15 minutes
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28.4 units on a scale
Standard Deviation 20.6
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Subject Pain Assessment by Visual Analogue Scale (VAS) 15 and 120 Minutes After Treatment.
Restylane SubQ Lidocaine, VAS at 15 minutes
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2.9 units on a scale
Standard Deviation 4.1
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Subject Pain Assessment by Visual Analogue Scale (VAS) 15 and 120 Minutes After Treatment.
Restylane SubQ, VAS at 120 minutes
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7.3 units on a scale
Standard Deviation 11.1
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Subject Pain Assessment by Visual Analogue Scale (VAS) 15 and 120 Minutes After Treatment.
Restylane SubQ Lidocaine, VAS at 120 minutes
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1.3 units on a scale
Standard Deviation 3.3
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SECONDARY outcome
Timeframe: 2 weeksPopulation: Intention to treat. 54/54 subjects
Esthetic improvement was evaluated by using Global Esthetic Improvement Scale. GEIS was evaluated by comparing current photos with pre-treatment photos and using a 5-graded scale (worse/no change/somewhat improved/much improved/very much improved). A clinically significant global esthetic improvement was defined as a score of somewhat improved, much improved or very much improved. GEIS was assessed by the Investigator and the subject. Each cheek/study product was evaluated separately. GEIS was assessed at the time points 2 weeks, 3 months, 2 weeks after re-treatment and 6, 9 and 12 months after first treatment.
Outcome measures
| Measure |
Restylane SubQ/Restylane SubQ Lidocaine
n=54 Participants
The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
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|---|---|
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Percentage of Improved Subjects at 2 Weeks After Treatment as Assessed by Use of Global Esthetic Improvement Scale (GEIS)
Restylane SubQ, subject GEIS, improved
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90.7 percentage of participants
Interval 79.7 to 96.9
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Percentage of Improved Subjects at 2 Weeks After Treatment as Assessed by Use of Global Esthetic Improvement Scale (GEIS)
Restylane SubQ, investigator GEIS, improved
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96.3 percentage of participants
Interval 87.3 to 99.5
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Percentage of Improved Subjects at 2 Weeks After Treatment as Assessed by Use of Global Esthetic Improvement Scale (GEIS)
Restylane SubQ Lidocain, subject GEIS, improved
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92.6 percentage of participants
Interval 82.1 to 97.9
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Percentage of Improved Subjects at 2 Weeks After Treatment as Assessed by Use of Global Esthetic Improvement Scale (GEIS)
Restylane SubQ Lidocaine, invest. GEIS, improved
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100.0 percentage of participants
Interval 93.4 to 100.0
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SECONDARY outcome
Timeframe: 2 weeksPopulation: Intention to treat. 54/54 subjects
The severity of midface volume loss or midface contour deficiency was assessed by the investigators using a 4-graded scale, Medicis Midface Volume Scale -MMVS (1, fairly full; 2, mild loss of fullness; 3, moderate loss, slight hollowing; and 4, substantial loss, clearly apparent hollowing). Each score were exemplified by photographic images on the scale. A one grade decrease in score from screening was defined as a treatment success/improvement.The efficacy in terms of Medicis Midface Volume Scale (MMVS) was assessed by the Investigator per treatment group. The two cheeks were evaluated separately. MMVS was assessed at the time points 2 weeks, 3 months, 2 weeks after re-treatment and 6, 9 and 12 months after first treatment.
Outcome measures
| Measure |
Restylane SubQ/Restylane SubQ Lidocaine
n=54 Participants
The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
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Percentage of Subjects With at Least One Step Improvement on Medicis Midface Volume Scale (MMVS) at 2 Weeks
Restylane SubQ, improved MMVS at 2 weeks
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55.6 percentage of participants
Interval 41.4 to 69.1
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Percentage of Subjects With at Least One Step Improvement on Medicis Midface Volume Scale (MMVS) at 2 Weeks
Restylane SubQ Lidocaine, improved MMVS at 2 weeks
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59.3 percentage of participants
Interval 45.0 to 72.4
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SECONDARY outcome
Timeframe: 14 daysPopulation: Safety Population. 54/54 subjects.
A subject diary was completed for 14 days following the initial treatment and the optional re-treatment at the 3-month visit. Each subject was asked to record the presence of bruising, redness, swelling, pain, tenderness and itching.
Outcome measures
| Measure |
Restylane SubQ/Restylane SubQ Lidocaine
n=54 Participants
The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
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Number of Subjects Reporting at Least 1 Diary Complaint Related to the Cheek Treated With Restylane SubQ and Restylane SubQ Lidocaine Respectively After Initial Treatment.
Restylane SubQ
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54 participants
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Number of Subjects Reporting at Least 1 Diary Complaint Related to the Cheek Treated With Restylane SubQ and Restylane SubQ Lidocaine Respectively After Initial Treatment.
Restylane SubQ Lidocaine
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52 participants
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SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Safety population, 54 subjects.
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects. All subjects were injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek.
Outcome measures
| Measure |
Restylane SubQ/Restylane SubQ Lidocaine
n=54 Participants
The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
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Number of Subjects Reporting Adverse Event
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41 participants
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Adverse Events
Restylane SubQ/Restylane SubQ Lidocaine: Systemic
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Restylane SubQ: Localized
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Restylane SubQ Lidocaine: Localized
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Restylane SubQ/Restylane SubQ Lidocaine: Systemic
n=54 participants at risk
The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.Hence, all subjects received injections with both products at the same time.
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Restylane SubQ: Localized
n=54 participants at risk
The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.Hence, all subjects received injections with both products at the same time
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Restylane SubQ Lidocaine: Localized
n=54 participants at risk
The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.Hence, all subjects received injections with both products at the same time
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Gastrointestinal disorders
Peptic Ulcer Hemorrhage
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1.9%
1/54 • Number of events 1 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
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0.00%
0/54 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
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0.00%
0/54 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
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Vascular disorders
Mesenteric Vein Thrombosis
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1.9%
1/54 • Number of events 1 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
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0.00%
0/54 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
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0.00%
0/54 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
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Cardiac disorders
Cardiac Failure
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1.9%
1/54 • Number of events 1 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
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0.00%
0/54 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
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0.00%
0/54 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
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Cardiac disorders
Atrial Fibrillation
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1.9%
1/54 • Number of events 1 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
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0.00%
0/54 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
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0.00%
0/54 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
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Other adverse events
| Measure |
Restylane SubQ/Restylane SubQ Lidocaine: Systemic
n=54 participants at risk
The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.Hence, all subjects received injections with both products at the same time.
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Restylane SubQ: Localized
n=54 participants at risk
The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.Hence, all subjects received injections with both products at the same time
|
Restylane SubQ Lidocaine: Localized
n=54 participants at risk
The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.Hence, all subjects received injections with both products at the same time
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|---|---|---|---|
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General disorders
Implant site inflammation
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0.00%
0/54 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
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20.4%
11/54 • Number of events 30 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
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18.5%
10/54 • Number of events 21 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
|
|
General disorders
Implant site swelling
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0.00%
0/54 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
|
11.1%
6/54 • Number of events 7 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
|
9.3%
5/54 • Number of events 5 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
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General disorders
Injection site pain
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0.00%
0/54 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
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16.7%
9/54 • Number of events 9 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
|
7.4%
4/54 • Number of events 4 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
|
|
General disorders
Implant site nodule
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0.00%
0/54 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
|
13.0%
7/54 • Number of events 7 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
|
7.4%
4/54 • Number of events 4 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
|
|
General disorders
Implant Site Pruritus
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0.00%
0/54 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
|
5.6%
3/54 • Number of events 4 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
|
7.4%
4/54 • Number of events 7 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
|
|
General disorders
Implant site erythema
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0.00%
0/54 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
|
5.6%
3/54 • Number of events 3 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
|
5.6%
3/54 • Number of events 3 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
|
|
General disorders
Implant site haematoma
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0.00%
0/54 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
|
9.3%
5/54 • Number of events 5 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
|
0.00%
0/54 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
6/54 • Number of events 6 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
|
0.00%
0/54 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
|
0.00%
0/54 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
|
|
Nervous system disorders
Headache
|
7.4%
4/54 • Number of events 4 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
|
0.00%
0/54 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
|
0.00%
0/54 • From treatment up to 12 months
Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication or presentation by PI shall be submitted to Q-Med for review no less than 60 days before submission for publication or presentation. Q-Med will provide any comments to Principal Investigator within thirty (30) days following receipt of the proposed publication/presentation. PI agrees to consider, discuss and give reasonable considerations to comments by Q-Med. Q-Med may also request that the Company name or Q-Med employee name appear or not appear in such publication.
- Publication restrictions are in place
Restriction type: OTHER