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

Galderma R&D211 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

211

Conditions

Wrinkle

Interventions

GAL1906DEVICE

Eligibility

Sex: FEMALEMin age: 22 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 was willing to comply with the requirements of the study and provide a signed written informed consent. * Subject had 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 was pregnant or nursing AND has no mammogram taken post GAL1906 treatment.

Locations (14)

Galderma Research Site

Birmingham, Alabama, United States

Galderma Research Site

Scottsdale, Arizona, United States

Galderma Research Site

Redondo Beach, California, United States

Galderma Research Site

San Diego, California, United States

Galderma Research Site

Vista, California, United States

Galderma Research Site

Westport, Connecticut, United States

Galderma Research Site

Boynton Beach, Florida, United States

Galderma Research Site

Coral Gables, Florida, United States

Galderma Research Site

Alpharetta, Georgia, United States

Galderma Research Site

Chicago, Illinois, United States

...and 4 more locations

Outcomes

Primary Outcomes

Percentage of Responders on the Galderma Decolletage Scale, as Assessed Live by the Blinded Evaluator, at Week 12

Responder was defined as participants having at least one grade improvement from baseline on the Galderma decolletage scale. Galderma Decolletage Scale was a validated 5-point scale used to assess the severity of lines and wrinkles in the décolletage area where: Grade 0 (none to minimal), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (very severe). Higher scores indicated more severe lines and wrinkles in the décolletage area. Percentage of responders as assessed live by the blinded evaluator has been reported for this outcome measure. 95% confidence interval was calculated using Clopper-Pearson method.

Time frame: At Week 12

Sub-study: Number of Participants With Breast Image Interference, as Determined by Adjudicated Radiologist

The number of participants with interference in breast images obtained using any diagnostic image modality (such as mammogram, breast ultrasound, breast magnetic resonance imaging \[MRI\], biopsy, and other procedure)as determined by adjudicated radiologist is reported.

Time frame: During treatment (anytime between Day 1 to Week 8 of main study), post first treatment on Day 1 and post last treatment (up to 12 months after receiving GAL1906 treatment in the Main study)