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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restylane SubQ | Other |
| |
| Restylane SubQ Lidocaine | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane SubQ | Device | Treatment with up to 2 ml of the product |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | When injection of both cheeks were completed |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15 and 120 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per Hedén, M.D. | Akademikliniken, Storängsvägen 10, 115 42 Stockholm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Plastikkirurggruppen | Stockholm | 113 24 | Sweden | |||
| ZMedical |
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.
First subject enrolled: September 10, 2011 Last subject visit: October 19, 2012
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Restylane SubQ Lidocaine |
| Device |
Treatment with up to 2 ml of the product |
|
| 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. | 2 weeks |
| 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. | 2 weeks |
| 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. | 14 days |
| 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. | Up to 12 months |
| Stockholm |
| 114 36 |
| Sweden |
| Akademikliniken | Stockholm | 115 42 | Sweden |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Intention to treat. 54/54 subjects | Posted | Number | 95% Confidence Interval | percentage of participants | When injection of both cheeks were completed |
|
|
| |||||||||||||||||||||||||
| 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. | Intention to treat. 54/54 subjects | Posted | Mean | Standard Deviation | units on a scale | 15 and 120 minutes |
|
| ||||||||||||||||||||||||||
| 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. | Intention to treat. 54/54 subjects | Posted | Number | 95% Confidence Interval | percentage of participants | 2 weeks |
|
| ||||||||||||||||||||||||||
| 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. | Intention to treat. 54/54 subjects | Posted | Number | 95% Confidence Interval | percentage of participants | 2 weeks |
| |||||||||||||||||||||||||||
| 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. | Safety Population. 54/54 subjects. | Posted | Number | participants | 14 days |
|
| |||||||||||||||||||||||||||
| 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. | Safety population, 54 subjects. | Posted | Number | participants | Up to 12 months |
|
|
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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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Restylane SubQ/Restylane SubQ Lidocaine: Systemic | 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. | 4 | 54 | 9 | 54 | ||
| EG001 | Restylane SubQ: Localized | 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 | 0 | 54 | 25 | 54 | ||
| EG002 | Restylane SubQ Lidocaine: Localized | 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 | 0 | 54 | 20 | 54 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mesenteric Vein Thrombosis | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Peptic Ulcer Hemorrhage | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant site inflammation | General disorders | MedDRA 15.0 | Systematic Assessment | All subjects recovered from these reaction before study end. |
|
| Implant site swelling | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Implant site nodule | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Implant Site Pruritus | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Implant site erythema | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Implant site haematoma | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Medical Affairs | Q-Med AB | +46 (0) 18 474 90 00 | reception.SEUPP@galderma.com |
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