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The purpose of this study is to determine the safety and efficacy of using Restylane Vital for skin rejuvenation of the dorsal hands. Assessment of improvement of skin structure will be done by a blinded evaluator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restylane Vital in both hands | Experimental | Open group used to develop a proper use of injection technique for Restylane Vital |
|
| Restylane Vital and No treatment | Other | Split-hand design: Restylane Vital in one hand and initially no treatment in the other hand |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane Vital | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Efficacy of Restylane Vital on Skin Structure Compared to no Treatment Using a Validated Scale. | Assessment of the severity of hand aging using a 5-point (ranging from 0-5) photo numeric rating scale (Hand Grading Scale), where higher scores mean a worse outcome. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Q-Med AB | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | China | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Restylane Vital in Both Hands | |
| FG001 | Restylane Vital in Randomized Hand, no Treatment in the Other |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Restylane Vital in Both Hands | |
| BG001 | Restylane Vital in Randomized Hand, no Treatment in the Other | |
| BG002 | Total |
| 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 |
| 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 | The Efficacy of Restylane Vital on Skin Structure Compared to no Treatment Using a Validated Scale. | Assessment of the severity of hand aging using a 5-point (ranging from 0-5) photo numeric rating scale (Hand Grading Scale), where higher scores mean a worse outcome. | The 9 subjects treated with Restylane Vital in both hands not included | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
1 year, 6 months (AE reporting on each subject started at visit 2 and continued during each follow-up visit (including telephone contacts and extra visits between planned visits) until the last scheduled visit in the study.)
Each subject should be questioned about AEs at each study visit following the screening visit.
The question asked should be:"Since your last clinical visit have you had any health problems?" Information on AEs can also be obtained from signs and symptoms detected during each examination, observations made by the study site personnel, subject diaries, 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 in Both Hands | Restylane Vital in both hands | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic gastritis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant site erythema | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Development | Q-Med AB | + 46 (0) 18 474 90 00 | reception.seupp@galderma.com |
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| Shanghai |
| China |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Restylane Vital in Randomized Hand | Restylane Vital in randomized hand | 0 | 100 | 2 | 100 | 12 | 100 |
| EG002 | No-treatment Control Hand | No treatment control hand | 0 | 100 | 2 | 100 | 3 | 100 |
| Worsening of lumbar disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Implant site pruritus | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Injection site discolouration | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Injection site nodule | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Folliculitis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
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