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

NCT01774396 | Completed Phase 4

• 1 other identifier: 08-2012
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Injuries to the Wrist and Hand

Keywords

Hands Rejuvenation, fillers

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Drug: Emervel® Volume Lidocaine and Emervel® Deep Lidocaine

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

Drug: Emervel® Touch; Drug: Emervel® Volume Lidocaine and Emervel® Deep Lidocaine

Interventions

Emervel® Touch DRUG

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

group 1

Emervel® Volume Lidocaine and Emervel® Deep Lidocaine DRUG

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

group 1; group 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hexsel Dermatology Clinic: lead

Study Sites (1)

Brazilian center of Dermatology Studies

Porto Alegre, Rio Grande do Sul, 90570-040, Brazil

Location

Study Officials

• Doris Hexsel, MD

  BRAZILIAN CENTER FOR STUDIES IN DERMATOLOGY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 28, 2012
• First Posted: January 24, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 26, 2015

Record last verified: 2015-02

Locations

BR (1)