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

NCT ID: NCT01774396

Last Updated: 2015-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-12-31

Brief Summary

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

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.

Conditions

Injuries to the Wrist and Hand

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: OTHER

Emervel® Volume Lidocaine and Emervel® Deep Lidocaine

Intervention Type: DRUG

Emervel® Volume Lidocaine and Emervel® Deep Lidocaine will be injected in the group #2.

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

Group Type: EXPERIMENTAL

Emervel® Touch

Intervention Type: DRUG

Emervel® Touch will be injected only in the intervention group.

Emervel® Volume Lidocaine and Emervel® Deep Lidocaine

Intervention Type: DRUG

Emervel® Volume Lidocaine and Emervel® Deep Lidocaine will be injected in the group #2.

Interventions

Emervel® Touch

Emervel® Touch will be injected only in the intervention group.

Intervention Type: DRUG

Emervel® Volume Lidocaine and Emervel® Deep Lidocaine

Emervel® Volume Lidocaine and Emervel® Deep Lidocaine will be injected in the group #2.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Brazilan Center for Studies in Dermatology

OTHER

Sponsor Role: lead

Responsible Party

Doris Hexsel

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Doris Hexsel, MD

Role: PRINCIPAL_INVESTIGATOR

BRAZILIAN CENTER FOR STUDIES IN DERMATOLOGY

Locations

Brazilian center of Dermatology Studies

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

08-2012

Identifier Type: -

Identifier Source: org_study_id