Clinical trial NCT01774396: Use Of Three Commercial Preparations Of Injectable Hyaluronic Acid In Hands Rejuvenation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Injuries to the Wrist and Hand
Keywords: Hands Rejuvenation, fillers
Lead sponsor: Brazilan Center for Studies in Dermatology
Sponsor class: OTHER
First posted: 2013-01-24
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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
timeFrame: at baseline and up to 180 days
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Brazilian center of Dermatology Studies
state: RS
Study officials:
affiliation: BRAZILIAN CENTER FOR STUDIES IN DERMATOLOGY
name: Doris Hexsel, MD
role: PRINCIPAL_INVESTIGATOR
References: