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The purpose of this study is to demonstrate the efficacy and safety of Restylane Vital Lidocaine when acne scars are treated
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restylane Vital Lidocaine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane Vital Lidocaine | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Acne Scarring and the Surrounding Skin Using the Global Aesthetic Improvement Scale | Percentage of improved subjects at 36 weeks after first treatment session assessed using Subject GAIS. Scale range is Worse, No Change, Somewhat Improved, Much Improved and Very Much Improved. Alternatives Somewhat Improved to Very Much Improved are considered an improvement, i.e. a better outcome. | 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Skin Quality and Overall Satisfaction Using a Subject Satisfaction Questionnaire | Percentage of subjects satisfied with the overall appearance of the face at 36 weeks after first treatment session. Scale range is Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied and Very satisfied. Alternatives Somewhat satisfied to Very satified are considered a better outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Dierickx, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin and Laser Center | Boom | 2850 | Belgium |
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| ID | Title | Description |
|---|---|---|
| FG000 | Restylane Vital Lidocaine | Restylane Vital Lidocaine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Restylane Vital Lidocaine | Restylane Vital Lidocaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Evaluation of Acne Scarring and the Surrounding Skin Using the Global Aesthetic Improvement Scale | Percentage of improved subjects at 36 weeks after first treatment session assessed using Subject GAIS. Scale range is Worse, No Change, Somewhat Improved, Much Improved and Very Much Improved. Alternatives Somewhat Improved to Very Much Improved are considered an improvement, i.e. a better outcome. | Posted | Number | percentage of participants | 36 weeks |
|
|
Adverse events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by 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 Vital Lidocaine | Restylane Vital Lidocaine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant site bruising | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Q-Med AB | + 46 (0) 18 474 90 00 | Reception.SEUPP@galderma.com |
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| 36 weeks |
| Evaluation of Acne Scarring Using the Scale for Acne Scar Severity (SCAR-S) | Percentage of subjects improved at 36 weeks after first treatment session assessed using SCAR-S. Scale range is Very severe, Severe, Moderate, Mild, Almost clear and Clear. The alternative Clear is considered the best outcome. Improvement is considered to be at least one step improvement on the scale toward the alternative Clear. | 36 weeks |
| Assessment of Local Tolerability After Treatment | Number of subjects reporting anticipated injection-related reactions after treatment | 14 days |
| Adverse Event Reporting During the Study | Number of subjects reporting at least one adverse event (assessed as unrelated or related to treatment) | 36 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Evaluation of Skin Quality and Overall Satisfaction Using a Subject Satisfaction Questionnaire | Percentage of subjects satisfied with the overall appearance of the face at 36 weeks after first treatment session. Scale range is Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied and Very satisfied. Alternatives Somewhat satisfied to Very satified are considered a better outcome. | Posted | Number | percentage of participants | 36 weeks |
|
|
|
| Secondary | Evaluation of Acne Scarring Using the Scale for Acne Scar Severity (SCAR-S) | Percentage of subjects improved at 36 weeks after first treatment session assessed using SCAR-S. Scale range is Very severe, Severe, Moderate, Mild, Almost clear and Clear. The alternative Clear is considered the best outcome. Improvement is considered to be at least one step improvement on the scale toward the alternative Clear. | Posted | Number | percentage of participants | 36 weeks |
|
|
|
| Secondary | Assessment of Local Tolerability After Treatment | Number of subjects reporting anticipated injection-related reactions after treatment | Posted | Number | participants | 14 days |
|
|
|
| Secondary | Adverse Event Reporting During the Study | Number of subjects reporting at least one adverse event (assessed as unrelated or related to treatment) | Posted | Number | participants | 36 weeks |
|
|
|
| 0 |
| 12 |
| 8 |
| 12 |
| Implant site erythema | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Implant site inflammation | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Implant site mass | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Implant site nodule | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Implant site pain | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Implant site swelling | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Injection site inflammation | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Injection site warmth | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
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