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This is a randomized, evaluator-blind, split hand, multi-center study of the effectiveness and safety or Restylane Lyft with Lidocaine compared to no treatment for injection in the dorsal hand to correct volume deficits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restylane Lyft with Lidocaine | Experimental |
| |
| No Intervention | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane Lyft with Lidocaine | Device | An injectable gel of Hyaluronic Acid and Lidocaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Responder Rate Using Validated Hand Grading Scale | A responder is defined as a hand with at least one improvement from baseline. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Responder Rate Using Validated Hand Grading Scale | A responder is defined as a hand with at least one point improvement from baseline | 16 weeks |
| Responder Rate Using Validated Hand Grading Scale |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vista | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31568288 | Derived | Moradi A, Allen S, Bank D, Marmur E, Fagien S, Glaser DA, Maguire C, Cohen JL. A Prospective, Multicenter, Randomized, Evaluator-Blinded, Split-Hand Study to Evaluate the Effectiveness and Safety of Large-Gel-Particle Hyaluronic Acid with Lidocaine for the Correction of Volume Deficits in the Dorsal Hand. Plast Reconstr Surg. 2019 Oct;144(4):586e-596e. doi: 10.1097/PRS.0000000000006070. |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects | Subjects randomized to treatment with Restylane Lyft with Lidocaine in one hand and no treatment in the other |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
ITT Population
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| ID | Title | Description |
|---|---|---|
| BG000 | Restylane Lyft With Lidocaine | Restylane Lyft with Lidocaine: An injectable gel of Hyaluronic Acid and Lidocaine; Subjects were randomized to receive Restylane Lyft with Lidocaine in either the right or left hand. |
| 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 | Responder Rate Using Validated Hand Grading Scale | A responder is defined as a hand with at least one improvement from baseline. | ITT population | Posted | Count of Participants | Participants | 12 Weeks |
|
|
32 weeks
AEs were collected by subject direct report, subject interview, or obtained from signs/symptoms detected during examination.
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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 Lyft With Lidocaine | Restylane Lyft with Lidocaine: An injectable gel of Hyaluronic Acid and Lidocaine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peripheral Swelling | General disorders | MedDRA (18.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Assoc Director of Clinical Operations | Galderma Research & Development, LLC | 817-961-5000 | courtney.maguire@galderma.com |
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A responder is defined as a hand with at least one point improvement from baseline
| 20 weeks |
| Responder Rate Using Validated Hand Grading Scale | A responder is defined as a hand with at least one point improvement from baseline. | 24 weeks |
| Improvement in Hand as Evaluated by IPR | Independent Photographic Reviewer's assessment of improvement (Yes/No) | 12 weeks |
| Improvement in Hand as Evaluated by IPR | Independent Photographic Reviewer's assessment of improvement (Yes/No) | 16 weeks |
| Improvement in Hand as Evaluated by IPR | Independent Photographic Reviewer's assessment of improvement (Yes/No) | 20 weeks |
| Improvement in Hand as Evaluated by IPR | Independent Photographic Reviewer's assessment of improvement (Yes/No) | 24 weeks |
| GAIS by Treating Investigator | Global Aesthetic Improvement Scale | 12 weeks |
| GAIS by Treating Investigator | Global Aesthetic Improvement Scale | 16 weeks |
| GAIS by Treating Investigator | Global Aesthetic Improvement Scale | 20 weeks |
| GAIS by Treating Investigator | Global Aesthetic Improvement Scale | 24 weeks |
| Evaluate GAIS by Subjects | Global Aesthetic Improvement Scale | 12 weeks |
| Evaluate GAIS by Subjects | Global Aesthetic Improvement Scale | 16 weeks |
| Evaluate GAIS by Subjects | Global Aesthetic Improvement Scale | 20 weeks |
| Evaluate GAIS by Subject | Global Aesthetic Improvement Scale | 24 weeks |
| Question 1 From Subject Satisfaction Questionnaire | Question 1: I am happier with the overall appearance of my treated hand compared to my untreated hand | Week 12 |
| Question 2 From Subject Satisfaction Questionnaire | Question 2: My treated hand appears more attractive than my untreated hand | Week 12 |
| Question 3 From Subject Satisfaction Questionnaire | Question 3: My treated hand looks more youthful than my untreated hand | Week 12 |
| Question 4 From Subject Satisfaction Questionnaire | Question 4: My treated hand feels softer than my untreated hand | Week 12 |
| Question 5 From Subject Satisfaction Questionnaire | Question 5: The skin on my treated hand appears tighter than on my untreated hand | Week 12 |
| Question 6 From Subject Satisfaction Questionnaire | Question 6: My treated hand looks less bony than my untreated hand | Week 12 |
| Question 7 From Subject Satisfaction Questionnaire | Question 7: The veins on my treated hand are less apparent compared to my untreated hand | Week 12 |
| Question 8 From Subject Satisfaction Questionnaire | Question 8: My treated hand appears at least 5 years younger than my untreated hand | Week 12 |
| Question 9 From Subject Satisfaction Questionnaire | Question 9: My treated hand appears at least 10 years younger than my untreated hand | Week 12 |
| Question 10 From Subject Satisfaction Questionnaire | Question 10: The skin on my treated hand appears hydrated | Week 12 |
| Question 11 From Subject Satisfaction Questionnaire | Question 11: The treatment result looks natural | Week 12 |
| Question 12 From Subject Satisfaction Questionnaire | Question 12: I would recommend this treatment to a friend | Week 12 |
| Question 13 From Subject Satisfaction Questionnaire | Question 13: I would have another treatment to maintain these results | Week 12 |
| Boulder |
| Colorado |
| United States |
| Englewood | Colorado | United States |
| Boca Raton | Florida | United States |
| St Louis | Missouri | United States |
| Mount Kisco | New York | United States |
| New York | New York | United States |
| Due to Medical Condition |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Fitzpatrick Skin Type | Count of Participants | Participants |
|
| Hand Grading Scale - Treated hand | Hand grading scale assessed by the Blinded evaluator | Count of Participants | Participants |
|
| Hand Grading Scale - Fellow Hand | Hand grading scale assessed by the Blinded evaluator | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Responder Rate Using Validated Hand Grading Scale | A responder is defined as a hand with at least one point improvement from baseline | ITT | Posted | Count of Participants | Participants | 16 weeks |
|
|
|
|
| Secondary | Responder Rate Using Validated Hand Grading Scale | A responder is defined as a hand with at least one point improvement from baseline | ITT | Posted | Count of Participants | Participants | 20 weeks |
|
|
|
|
| Secondary | Responder Rate Using Validated Hand Grading Scale | A responder is defined as a hand with at least one point improvement from baseline. | ITT | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
|
| Secondary | Improvement in Hand as Evaluated by IPR | Independent Photographic Reviewer's assessment of improvement (Yes/No) | ITT | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | Improvement in Hand as Evaluated by IPR | Independent Photographic Reviewer's assessment of improvement (Yes/No) | ITT | Posted | Count of Participants | Participants | 16 weeks |
|
|
|
| Secondary | Improvement in Hand as Evaluated by IPR | Independent Photographic Reviewer's assessment of improvement (Yes/No) | ITT | Posted | Count of Participants | Participants | 20 weeks |
|
|
|
| Secondary | Improvement in Hand as Evaluated by IPR | Independent Photographic Reviewer's assessment of improvement (Yes/No) | ITT | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Secondary | GAIS by Treating Investigator | Global Aesthetic Improvement Scale | ITT | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | GAIS by Treating Investigator | Global Aesthetic Improvement Scale | ITT | Posted | Count of Participants | Participants | 16 weeks |
|
|
|
| Secondary | GAIS by Treating Investigator | Global Aesthetic Improvement Scale | ITT | Posted | Count of Participants | Participants | 20 weeks |
|
|
|
| Secondary | GAIS by Treating Investigator | Global Aesthetic Improvement Scale | ITT | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Secondary | Evaluate GAIS by Subjects | Global Aesthetic Improvement Scale | ITT | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | Evaluate GAIS by Subjects | Global Aesthetic Improvement Scale | ITT | Posted | Count of Participants | Participants | 16 weeks |
|
|
|
| Secondary | Evaluate GAIS by Subjects | Global Aesthetic Improvement Scale | ITT | Posted | Count of Participants | Participants | 20 weeks |
|
|
|
| Secondary | Evaluate GAIS by Subject | Global Aesthetic Improvement Scale | ITT | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Secondary | Question 1 From Subject Satisfaction Questionnaire | Question 1: I am happier with the overall appearance of my treated hand compared to my untreated hand | ITT | Posted | Count of Participants | Participants | Week 12 |
|
|
|
| Secondary | Question 2 From Subject Satisfaction Questionnaire | Question 2: My treated hand appears more attractive than my untreated hand | ITT | Posted | Count of Participants | Participants | Week 12 |
|
|
|
| Secondary | Question 3 From Subject Satisfaction Questionnaire | Question 3: My treated hand looks more youthful than my untreated hand | ITT | Posted | Count of Participants | Participants | Week 12 |
|
|
|
| Secondary | Question 4 From Subject Satisfaction Questionnaire | Question 4: My treated hand feels softer than my untreated hand | ITT | Posted | Count of Participants | Participants | Week 12 |
|
|
|
| Secondary | Question 5 From Subject Satisfaction Questionnaire | Question 5: The skin on my treated hand appears tighter than on my untreated hand | ITT | Posted | Count of Participants | Participants | Week 12 |
|
|
|
| Secondary | Question 6 From Subject Satisfaction Questionnaire | Question 6: My treated hand looks less bony than my untreated hand | ITT | Posted | Count of Participants | Participants | Week 12 |
|
|
|
| Secondary | Question 7 From Subject Satisfaction Questionnaire | Question 7: The veins on my treated hand are less apparent compared to my untreated hand | ITT | Posted | Count of Participants | Participants | Week 12 |
|
|
|
| Secondary | Question 8 From Subject Satisfaction Questionnaire | Question 8: My treated hand appears at least 5 years younger than my untreated hand | ITT | Posted | Count of Participants | Participants | Week 12 |
|
|
|
| Secondary | Question 9 From Subject Satisfaction Questionnaire | Question 9: My treated hand appears at least 10 years younger than my untreated hand | ITT | Posted | Count of Participants | Participants | Week 12 |
|
|
|
| Secondary | Question 10 From Subject Satisfaction Questionnaire | Question 10: The skin on my treated hand appears hydrated | ITT | Posted | Count of Participants | Participants | Week 12 |
|
|
|
| Secondary | Question 11 From Subject Satisfaction Questionnaire | Question 11: The treatment result looks natural | ITT | Posted | Count of Participants | Participants | Week 12 |
|
|
|
| Secondary | Question 12 From Subject Satisfaction Questionnaire | Question 12: I would recommend this treatment to a friend | ITT | Posted | Count of Participants | Participants | Week 12 |
|
|
|
| Secondary | Question 13 From Subject Satisfaction Questionnaire | Question 13: I would have another treatment to maintain these results | ITT | Posted | Count of Participants | Participants | Week 12 |
|
|
|
| 0 |
| 89 |
| 0 |
| 89 |
| 37 |
| 89 |
| Laceration | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Tooth Infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Thermal Burn | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Vitreous Detachment | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Cyst Rupture | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Device Failure | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Facial Pain | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Chronic Sinusitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Oral Herpes | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Animal Scratch | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Burns first degree | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Eye Injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Limb Injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Nail Injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Blood Cholesterol Increased | Investigations | MedDRA (18.0) | Systematic Assessment |
|
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