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CompletedNCT01774396Updated Feb 26, 2015

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

A Phase 4 interventional study of Emervel® Touch and Emervel® Volume Lidocaine and Emervel® Deep Lidocaine in Injuries to the Wrist and Hand, sponsored by Brazilan Center for Studies in Dermatology. Completed at 1 site in Brazil. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-02-26.

Sponsored by Brazilan Center for Studies in Dermatology · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Injuries to the Wrist and Hand

Keywords

  • Hands Rejuvenation, fillers
03

In context

Lead sponsor

Brazilan Center for Studies in Dermatology is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
30 participants (actual)

Study arms

  • Other
    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

  • 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 · Drug: Emervel® Volume Lidocaine and Emervel® Deep Lidocaine

Interventions

  • DrugEmervel® Touch

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

  • DrugEmervel® Volume Lidocaine and Emervel® Deep Lidocaine

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

06

What researchers measure

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.

    Time frame: at baseline and up to 180 days

07

Study locations

1 site
  • Brazilian center of Dermatology Studies
    Porto Alegre, RS 90570-040, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01774396
Lead sponsor
Brazilan Center for Studies in Dermatology
Responsible party
Doris Hexsel (MD, Brazilan Center for Studies in Dermatology) — Principal investigator
First posted
Jan 24, 2013
Start date
Jan 2013
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Feb 26, 2015

Study contacts

Doris Hexsel, MD
principal investigator · BRAZILIAN CENTER FOR STUDIES IN DERMATOLOGY

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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