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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01774396
First Posted: January 24, 2013
Last Update Posted: February 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Doris Hexsel, Brazilan Center for Studies in Dermatology
  Purpose
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.

Condition Intervention Phase
Injuries to the Wrist and Hand Drug: Emervel® Touch Drug: Emervel® Volume Lidocaine and Emervel® Deep Lidocaine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Doris Hexsel, Brazilan Center for Studies in Dermatology:

Primary Outcome Measures:
  • 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 [ Time Frame: at baseline and up to 180 days ]
    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.


Enrollment: 30
Study Start Date: January 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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® Touch
Emervel® Touch will be injected only in the intervention group.
Drug: Emervel® Volume Lidocaine and Emervel® Deep Lidocaine
Emervel® Volume Lidocaine and Emervel® Deep Lidocaine will be injected in the group #2.

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

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01774396


Locations
Brazil
Brazilian center of Dermatology Studies
Porto Alegre, RS, Brazil, 90570-040
Sponsors and Collaborators
Brazilan Center for Studies in Dermatology
Investigators
Principal Investigator: Doris Hexsel, MD BRAZILIAN CENTER FOR STUDIES IN DERMATOLOGY
  More Information

Responsible Party: Doris Hexsel, MD, Brazilan Center for Studies in Dermatology
ClinicalTrials.gov Identifier: NCT01774396     History of Changes
Other Study ID Numbers: 08-2012
First Submitted: December 28, 2012
First Posted: January 24, 2013
Last Update Posted: February 26, 2015
Last Verified: February 2015

Keywords provided by Doris Hexsel, Brazilan Center for Studies in Dermatology:
Hands Rejuvenation, fillers

Additional relevant MeSH terms:
Finger Injuries
Hand Injuries
Wounds and Injuries
Lidocaine
Hyaluronic Acid
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Viscosupplements
Protective Agents