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GAL1906 for Wrinkles
Chicago, IL
N/A
Recruiting
Research Sponsored by Q-Med AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks after initial injection
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new treatment called GAL1906 to see if it can safely and effectively reduce wrinkles in the upper chest area. It focuses on people who want to improve the appearance of their skin in that region.
See full description
Who is the study for?
This trial is for non-pregnant, non-breastfeeding women over 21 seeking to reduce wrinkles in the décolletage area. Participants must be willing to follow study requirements and not have allergies to lidocaine, other anesthetics, injectable HA gels, or gram-positive bacterial proteins.
What is being tested?
The main study tests the safety and effectiveness of GAL1906 in correcting décolletage wrinkles. It's a randomized, evaluator-blinded study with no treatment control. A sub-study checks if these treatments affect mammogram readings.See study design
What are the potential side effects?
While specific side effects are not listed here, common reactions may include skin irritation at the injection site, swelling, bruising or allergic responses related to ingredients like hyaluronic acid or lidocaine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks after initial injection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks after initial injection
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Main study: The percentage of responders on the Galderma Décolletage Scale, as assessed live by the Blinded Evaluator, at Week 12.
Sub-study: Incidence of Breast Image Interference, as Determined by Adjudicated Radiologist
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: GAL1906Experimental Treatment1 Intervention
Experimental product for correction of wrinkles
Group II: ControlActive Control1 Intervention
No treatment control
Find a Location
Closest Location:Galderma Research Site· Chicago, IL· 276 miles
Who is running the clinical trial?
Q-Med ABLead Sponsor
80 Previous Clinical Trials
12,477 Total Patients Enrolled
1 Trials studying Wrinkles
110 Patients Enrolled for Wrinkles
Galderma R&DLead Sponsor
302 Previous Clinical Trials
60,468 Total Patients Enrolled
8 Trials studying Wrinkles
1,156 Patients Enrolled for Wrinkles
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Subjects must be willing to comply with the requirements of the study and must provide a written informed consent.You are looking to treat the skin on your upper chest area.You are non-pregnant, non-breastfeeding females, over the age of 21.
Research Study Groups:
This trial has the following groups:- Group 1: GAL1906
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Wrinkles Patient Testimony for trial: Trial Name: NCT04717934 — N/A