Use Of Three Commercial Preparations Of Injectable Hyaluronic Acid In Hands Rejuvenation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Trial On The Use Of Three Commercial Preparations Of Injectable Hyaluronic Acid (Emervel® Volume Lidocaine, Emervel® Deep Lidocaine And Emervel® Touch) In Hands Rejuvenation

Conditions
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Injuries to the Wrist and Hand

Intervention / Treatment
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* Drug: Emervel® Touch
* Drug: Emervel® Volume Lidocaine and Emervel® Deep Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects agreeing to take part of all procedures of the study (including pre-test, filler injection, photographs, etc.), after being fully informed on the objectives and nature of the investigations; Written Informed Consent; Treatment-naive patients for fillers in hands; Subjects of both genders over 18 years; Fitzpatrick skin phototypes I to VI; Subjects presenting a similar loss of fatty tissue on both hands, at least of 2 according the Validated Hand Grading Scale2; Medical history and physical examination which, based on the investigator's opinion, do not prevent the patient from taking part in the study and use the product under investigation; Female subjects of childbearing age should present a negative urine pregnancy test and should be using an effective contraceptive method; Availability of the subject throughout the duration of the study (208 days); Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol. Exclusion Criteria: Pregnant women or women intending to become pregnant in the next 18 months; Subjects with known hypersensitivity to any hyaluronic acid products; Subjects with history of adverse effects, such as sensitivity to the components of the formula, or any other adverse effect, which in the investigator's opinion should prevent the patient from participating in the study; Subjects participating in other clinical trials; Any prior surgery or side effects at the hands area, or any prior cosmetic procedures, including permanent fillers, that may interfere with the results; Subjects with active inflammation or infection in the area to be treated; Subjects with a history of medical treatment non-adherence or showing unwillingness to adhere to the study protocol; Subjects presenting diseases such as coagulation disorders or under the use of anticoagulants, or any condition that, in the opinion of the investigator, can compromise the evaluation of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: group 2<br>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. | Drug: Emervel® Volume Lidocaine and Emervel® Deep Lidocaine<br>* Emervel® Volume Lidocaine and Emervel® Deep Lidocaine will be injected in the group #2.<br>|
| Experimental: group 1<br>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 | Drug: Emervel® Touch<br>* Emervel® Touch will be injected only in the intervention group.<br>Drug: Emervel® Volume Lidocaine and Emervel® Deep Lidocaine<br>* Emervel® Volume Lidocaine and Emervel® Deep Lidocaine will be injected in the group #2.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hands Rejuvenation, fillers