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Assessment of efficacy of hyaluronic acid - Emervel® Volume Lidocaine combined or not with Emervel® Touch and Emervel® Deep Lidocaine combined or not with Emervel® Touch in female patients with loss of fatty tissue in hands.
This is a single center, phase IV, randomized, investigator-blind study of three different hyaluronic dermal filler injections for volume enhancing in the dorsum of the hands. As an investigator-blind study, only the investigators are unaware of which dermal fillers were injected in the dorsum of each hand.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 2 | Other | The intervention will be the injection of Emervel® Volume Lidocaine alone in the dorsa of one hand and Emervel® Deep Lidocaine alone in the dorsa of the contralateral hand. |
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| group 1 | Experimental | EThe intervention will be the injection of mervel® Volume Lidocaine plus Emervel® Touch in the dorsa of one hand and Emervel® Deep Lidocaine plus Emervel® Touch in the dorsa of the contralateral hand |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emervel® Touch | Drug | Emervel® Touch will be injected only in the intervention group. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of hyaluronic acid - Emervel® Volume Lidocaine combined or not with Emervel® Touchand Emervel® Deep Lidocaine combined or not with Emervel® Touch in subjects with with loss of fatty tissue | Assessment of efficacy of hyaluronic acid - Emervel® Volume Lidocaine combined or not with Emervel® Touch (Galderma) and Emervel® Deep Lidocaine combined or not with Emervel® Touch (Galderma) in female patients with loss of fatty tissue as a sign of aging on hands by Global Aesthetic Improvement scale1 and Hand Grading Scale2. | at baseline and up to 180 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Doris Hexsel, MD | BRAZILIAN CENTER FOR STUDIES IN DERMATOLOGY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brazilian center of Dermatology Studies | Porto Alegre | Rio Grande do Sul | 90570-040 | Brazil |
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| Emervel® Volume Lidocaine and Emervel® Deep Lidocaine |
| Drug |
Emervel® Volume Lidocaine and Emervel® Deep Lidocaine will be injected in the group #2. |
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