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

This study is currently recruiting participants.
Verified December 2012 by Brazilan Center for Studies in Dermatology
Sponsor:
Information provided by (Responsible Party):
Doris Hexsel, Brazilan Center for Studies in Dermatology
ClinicalTrials.gov Identifier:
NCT01774396
First received: December 28, 2012
Last updated: January 21, 2013
Last verified: December 2012
History of Changes
  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
Hands Rejuvenation
 Drug: Emervel® Touch
Drug: Emervel® Volume Lidocaine and Emervel® Deep Lidocaine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: January 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: group 2
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.
Other Name: Emervel® Volume Lidocaine and Emervel® Deep Lidocaine
Experimental: group 1
Emervel® 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.
Other Name: Emervel® Touch
Drug: Emervel® Volume Lidocaine and Emervel® Deep Lidocaine
Emervel® Volume Lidocaine and Emervel® Deep Lidocaine will be injected in the group #2.
Other Name: Emervel® Volume Lidocaine and Emervel® Deep Lidocaine

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01774396

Contacts
Contact: Doris M hexsel, MD 30262633 cbed@cbed.org.br

Locations
Brazil
Brazilian center of Dermatology Studies Recruiting
Porto Alegre, RS, Brazil, 90570-040
Contact: Doris M Hexsel, MD     30262633     cbed@cbed.org.br    
Contact: Carolina Siega, Bsc     30262633     cbed@cbed.org.br    
Principal Investigator: Doris M Hexsel, MD            
Sponsors and Collaborators
Brazilan Center for Studies in Dermatology
  More Information

No publications provided

Responsible Party: Doris Hexsel, MD, Brazilan Center for Studies in Dermatology
ClinicalTrials.gov Identifier: NCT01774396     History of Changes
Other Study ID Numbers: 08-2012
Study First Received: December 28, 2012
Last Updated: January 21, 2013
Health Authority: Brazil: National Committee of Ethics in Research

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

Additional relevant MeSH terms:
Hyaluronic Acid
Lidocaine
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anesthetics, Local
Anesthetics
 Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 16, 2013