Clinical trial NCT04717934: Main Study: A Study to Evaluate the Effectiveness and Safety of GAL1906 for Correction of Wrinkles in the décolletage Area Sub-study: A Follow-up Study to Evaluate the Analysis of Mammograms Following Treatment for Correction of Wrinkles in Décolletage Area in the Investigational Study 43USRV1906
Official title: Main Study: 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 Sub-study: A Follow-up Sub-study to Assess Interpretation of Mammograms Following Treatment for Correction of Wrinkles in the Décolletage Area in the Investigational Study 43USRV1906
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Wrinkle
Keywords: Wrinkles in the Décolletage Area
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2021-01-22
Enrollment: 192
Sex: FEMALE
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Sub-study: To evaluate imaging interpretation of mammograms in subjects who were enrolled and treated in the 43USRV1906 main study. The sub-study will determine if hyaluronic acid injections in the décolletage interfere with diagnosis or interpretation of mammogram results.


Eligibility criteria: Inclusion Criteria for Main study:

* 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.

Inclusion Criteria for Sub-study:

* Subject is willing to comply with the requirements of the study and provide a signed written informed consent.
* Subject has received treatment with GAL1906 in the main protocol.

Exclusion Criteria for Main study:

* 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).

Exclusion Criteria for Sub-study:

• Subject is pregnant or nursing AND has no mammogram taken post GAL1906 treatment.

Primary outcomes:
measure: Main study: The percentage of responders on the Galderma Décolletage Scale, as assessed live by the Blinded Evaluator, at Week 12.
timeFrame: 12 weeks after initial injection
measure: Sub-study: Incidence of Breast Image Interference, as Determined by Adjudicated Radiologist
timeFrame: Through the study completion, within 3 months of study start (approximately)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Galderma Research Site
state: Alabama
city: Scottsdale
country: United States
facility: Galderma Research Site
state: Arizona
city: Redondo Beach
country: United States
facility: Galderma Research Site
state: California
city: San Diego
country: United States
facility: Galderma Research Site
state: California
city: Vista
country: United States
facility: Galderma Research Site
state: California
city: Westport
country: United States
facility: Galderma Research Site
state: Connecticut
city: Boynton Beach
country: United States
facility: Galderma Research Site
state: Florida
city: Coral Gables
country: United States
facility: Galderma Research Site
state: Florida
city: Alpharetta
country: United States
facility: Galderma Research Site
state: Georgia
city: Chicago
country: United States
facility: Galderma Research Site
state: Illinois
city: Baltimore
country: United States
facility: Galderma Research Site
state: Maryland
city: New York
country: United States
facility: Galderma Research Site
state: New York
city: Spring
country: United States
facility: Galderma Research Site
state: Texas
city: Mequon
country: United States
facility: Galderma Research Site
state: Wisconsin
Study officials:
References: