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A Study to Evaluate the Effectiveness and Safety of GAL1906 for Correction of Wrinkles in the décolletage Area

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.
 
ClinicalTrials.gov Identifier: NCT04717934
Recruitment Status : Active, not recruiting
First Posted : January 22, 2021
Last Update Posted : January 18, 2022
Sponsor:
Information provided by (Responsible Party):
Q-Med AB

Study Description
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Brief Summary:
Randomized, evaluator-blinded, no treatment controlled multicenter study to evaluate safety and effectiveness of GAL1906 for the correction of wrinkles in the décolletage area.

Condition or disease Intervention/treatment Phase
Wrinkle Device: GAL1906 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Evaluator-blinded, No-treatment Controlled, Multicenter Study to Evaluate the Effectiveness and Safety of GAL1906 for Correction of Wrinkles in the décolletage Area
Actual Study Start Date : January 27, 2021
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : March 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: GAL1906 Device: GAL1906
hyaluronic acid dermal filler gel
No Intervention: Control


Outcome Measures
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Primary Outcome Measures :
  1. The percentage of responders on the Galderma Décolletage Scale, as assessed live by the Blinded Evaluator, at Week 12. [ Time Frame: 12 weeks after initial injection ]
    Responder defined as at least one grade improvement from baseline


Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects willing to comply with the requirements of the study and providing a signed written informed consent.
  • Non-pregnant, non-breastfeeding females, over the age of 21.
  • Subjects seeking treatment for the décolletage.

Exclusion Criteria:

  • Known/previous allergy or hypersensitivity to any injectable HA gel or to gram positive bacterial proteins.
  • History of allergy or hypersensitivity to lidocaine or other amidetype anesthetics, or topical anesthetics or nerve blocking agents (if such products are intended to be used for that subject).
Contacts and Locations
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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): NCT04717934


Locations
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United States, California
Galderma Research Site
Vista, California, United States, 92083
United States, Florida
Galderma Research Site
Coral Gables, Florida, United States, 33146
United States, New York
Galderma Research Site
New York, New York, United States, 10021
Sponsors and Collaborators
Q-Med AB
More Information
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Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT04717934    
Other Study ID Numbers: 43USRV1906
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: January 18, 2022
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Q-Med AB:
Wrinkles in the Décolletage Area