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The purpose of this study is to evaluate performance and safety of Restylane Lidocaine for treatment of depressed facial acne scars
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No-treatment control | Experimental |
| |
| Treatment | Experimental | Intradermal injection Restylane Lidocaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane Lidocaine | Device | Hyaluronic acid based filler |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Lower Scar Severity in the Treated Cheek Compared to the Untreated Cheek | Overall scar severity assessed by blinded evaluator. | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Improved on the Global Aesthetic Improvement Scale (GAIS) | Assessed by blinded evaluator | Month 1, Month 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Darmstadt | Darmstadt | Germany | ||||
| Munich |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30358630 | Result | Dierickx C, Larsson MK, Blomster S. Effectiveness and Safety of Acne Scar Treatment With Nonanimal Stabilized Hyaluronic Acid Gel. Dermatol Surg. 2018 Nov;44 Suppl 1:S10-S18. doi: 10.1097/DSS.0000000000001689. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Split-face: Treatment/No-treatment Control | All participants were randomized to receive treatment in either right or left cheek. The other cheek was a no-treatment control. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Split-face: Treatment/No-treatment Control | All participants were randomized to receive treatment in either right or left cheek. The other cheek was a no-treatment control. |
| 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 | Percentage of Participants With Lower Scar Severity in the Treated Cheek Compared to the Untreated Cheek | Overall scar severity assessed by blinded evaluator. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 3 |
|
|
1 year, 7 months
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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 | Split-face: Treatment/No-treatment Control | All participants were randomized to receive treatment in either right or left cheek. The other cheek was a no-treatment control. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening of spinal disc herniation | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Q-Med AB | +46184749000 | reception.seupp@galderma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 27, 2016 | Sep 11, 2019 | Prot_SAP_000.pdf |
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| No-treatment control |
| Other |
No-treatment control |
|
| Munich |
| Germany |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
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| Secondary | Percentage of Participants Improved on the Global Aesthetic Improvement Scale (GAIS) | Assessed by blinded evaluator | 48 participants at Month 1, 47 participants at Month 3, due to withdrawal. Split-face design: overall 48 participants, with one treated cheek and one cheek as no-treatment control. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 1, Month 3 | cheeks | cheeks |
|
|
|
| 0 |
| 49 |
| 1 |
| 49 |
| 9 |
| 49 |
| Nasopharyngitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
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| Month 3 |
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