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

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

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.

Study Overview

• Status: Completed
• Conditions: Injuries to the Wrist and Hand
• Intervention / Treatment: Drug: Emervel® Volume Lidocaine and Emervel® Deep Lidocaine; Drug: Emervel® Touch

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90570-040
      • Brazilian center of Dermatology Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brazilan Center for Studies in Dermatology
• Investigators: Principal Investigator: Doris Hexsel, MD, Brazilian Center For Studies in Dermatology

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: December 28, 2012
• First Submitted That Met QC Criteria: January 21, 2013
• First Posted (Estimate): January 24, 2013

Study Record Updates

• Last Update Posted (Estimate): February 26, 2015
• Last Update Submitted That Met QC Criteria: February 24, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Hands Rejuvenation, fillers
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 08-2012