Facial Tissue Augmentation
Conditions
Brief summary
The objectives of this study are to evaluate the pain-relieving effect and safety of adding lidocaine hydrochloride to Restylane SubQ and to evaluate the esthetic improvement obtained. The study products will be administered in the cheek.
Detailed description
The Restylane SubQ gel is intended to be used for facial tissue augmentation. The lidocaine content is designed to reduce the subject's pain during treatment. The objectives of this split-face designed study are to evaluate the pain-relieving effect and safety of adding lidocaine hydrochloride to Restylane SubQ and to evaluate the esthetic improvement obtained with the dermal filler using the global esthetic improvement scale (GEIS).
Interventions
DEVICERestylane SubQ
Treatment with up to 2 ml of the product
DEVICERestylane SubQ Lidocaine
Treatment with up to 2 ml of the product
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years of age or older. * Intent to undergo contouring of both cheeks with 1.5 to 2 ml Restylane SubQ per cheek. * Sufficient symmetry of the face in order to ensure similar volume to be injected, similar injection technique and time for injection. * Signed informed consent.
Exclusion criteria
* Surgery in the midface including aesthetic facial surgical therapy, sinus surgery or dental root surgery within the past 12 months. * Chronic infection in head and neck region. * Ongoing infections in mouth. * Tendency for edema, puffiness or swelling over the zygomatic prominence. * Active skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster near or on the area to be treated. * Previous hypersensitivity to hyaluronic acid or local anesthetics. * Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation within 10 days prior to treatment, or a history of bleeding disorders. * Cancerous or pre-cancerous lesions in the area to be treated. * Previous tissue augmenting therapy in the area to be treated with non-permanent filler, laser treatment, or chemical peeling during the last 6 months. * Permanent implant placed in the area to be treated. * Reduced sensibility in the facial region e.g. due to trauma, facial pareses, previous tissue augmenting therapy, aesthetic facial surgical therapy, laser treatment, or peeling. * Pregnancy or breast feeding. * Participation in any other clinical study within 30 days prior to inclusion. * Other condition preventing the subject to entering the study in the Investigator's opinion e.g. subjects not likely to avoid other facial cosmetic treatments below the level of the upper orbital rim, subjects anticipated to be unreliable or incapable of understanding the VAS assessment, insufficient tissue support or cover of the treatment area.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Who Assessed Treatment With Restylane SubQ Lidocaine as Least Painful. | When injection of both cheeks were completed | When injection of both cheeks was completed, the subject was asked which treatment was least painful (right cheek/left cheek/both cheeks alike). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Pain Assessment by Visual Analogue Scale (VAS) 15 and 120 Minutes After Treatment. | 15 and 120 minutes | 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. |
| Percentage of Improved Subjects at 2 Weeks After Treatment as Assessed by Use of Global Esthetic Improvement Scale (GEIS) | 2 weeks | 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. |
| Percentage of Subjects With at Least One Step Improvement on Medicis Midface Volume Scale (MMVS) at 2 Weeks | 2 weeks | 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. |
| 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. | 14 days | 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. |
| Number of Subjects Reporting Adverse Event | 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. All subjects were injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek. |
Countries
Sweden
Participant flow
Recruitment details
First subject enrolled: September 10, 2011 Last subject visit: October 19, 2012
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 54 |
| Total | 54 |
Baseline characteristics
| Characteristic | Restylane SubQ/Restylane SubQ Lidocaine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants |
| Age, Continuous | 53 years STANDARD_DEVIATION 13.1 |
| Region of Enrollment Sweden | 54 participants |
| Sex: Female, Male Female | 51 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 9 / 54 | 25 / 54 | 20 / 54 |
| serious Total, serious adverse events | 4 / 54 | 0 / 54 | 0 / 54 |
Outcome results
Primary
Percentage of Subjects Who Assessed Treatment With Restylane SubQ Lidocaine as Least Painful.
When injection of both cheeks was completed, the subject was asked which treatment was least painful (right cheek/left cheek/both cheeks alike).
Time frame: When injection of both cheeks were completed
Population: Intention to treat. 54/54 subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restylane SubQ/Restylane SubQ Lidocaine | Percentage of Subjects Who Assessed Treatment With Restylane SubQ Lidocaine as Least Painful. | 100 percentage of participants |
Secondary
Number of Subjects Reporting Adverse Event
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.
Time frame: Up to 12 months
Population: Safety population, 54 subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restylane SubQ/Restylane SubQ Lidocaine | Number of Subjects Reporting Adverse Event | 41 participants |
Secondary
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.
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.
Time frame: 14 days
Population: Safety Population. 54/54 subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Restylane SubQ/Restylane SubQ Lidocaine | 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 | 54 participants |
| Restylane SubQ/Restylane SubQ Lidocaine | 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 | 52 participants |
Secondary
Percentage of Improved Subjects at 2 Weeks After Treatment as Assessed by Use of Global Esthetic Improvement Scale (GEIS)
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.
Time frame: 2 weeks
Population: Intention to treat. 54/54 subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Restylane SubQ/Restylane SubQ Lidocaine | Percentage of Improved Subjects at 2 Weeks After Treatment as Assessed by Use of Global Esthetic Improvement Scale (GEIS) | Restylane SubQ, subject GEIS, improved | 90.7 percentage of participants |
| Restylane SubQ/Restylane SubQ Lidocaine | Percentage of Improved Subjects at 2 Weeks After Treatment as Assessed by Use of Global Esthetic Improvement Scale (GEIS) | Restylane SubQ, investigator GEIS, improved | 96.3 percentage of participants |
| Restylane SubQ/Restylane SubQ Lidocaine | 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 | 92.6 percentage of participants |
| Restylane SubQ/Restylane SubQ Lidocaine | 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 | 100.0 percentage of participants |
Secondary
Percentage of Subjects With at Least One Step Improvement on Medicis Midface Volume Scale (MMVS) at 2 Weeks
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.
Time frame: 2 weeks
Population: Intention to treat. 54/54 subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Restylane SubQ/Restylane SubQ Lidocaine | 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 | 55.6 percentage of participants |
| Restylane SubQ/Restylane SubQ Lidocaine | 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 | 59.3 percentage of participants |
Secondary
Subject Pain Assessment by Visual Analogue Scale (VAS) 15 and 120 Minutes After Treatment.
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.
Time frame: 15 and 120 minutes
Population: Intention to treat. 54/54 subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Restylane SubQ/Restylane SubQ Lidocaine | Subject Pain Assessment by Visual Analogue Scale (VAS) 15 and 120 Minutes After Treatment. | Restylane SubQ, VAS at 15 minutes | 28.4 units on a scale | Standard Deviation 20.6 |
| Restylane SubQ/Restylane SubQ Lidocaine | Subject Pain Assessment by Visual Analogue Scale (VAS) 15 and 120 Minutes After Treatment. | Restylane SubQ Lidocaine, VAS at 15 minutes | 2.9 units on a scale | Standard Deviation 4.1 |
| Restylane SubQ/Restylane SubQ Lidocaine | Subject Pain Assessment by Visual Analogue Scale (VAS) 15 and 120 Minutes After Treatment. | Restylane SubQ, VAS at 120 minutes | 7.3 units on a scale | Standard Deviation 11.1 |
| Restylane SubQ/Restylane SubQ Lidocaine | Subject Pain Assessment by Visual Analogue Scale (VAS) 15 and 120 Minutes After Treatment. | Restylane SubQ Lidocaine, VAS at 120 minutes | 1.3 units on a scale | Standard Deviation 3.3 |