Evaluation of the Effectiveness and Safety of Diluted RADIESSE® in the Treatment of Décolleté Wrinkles

Merz North America, Inc.152 enrolled

Overview

Trial to confirm the effectiveness and demonstrate the safety of treatment with diluted Radiesse for correction of Décolleté Wrinkles.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

152

Conditions

Décolleté Wrinkles

Interventions

Treatment with diluted RadiesseDEVICE

Injection of Décolleté Wrinkles with diluted Radiesse

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female between ≥ 30 and ≤ 65 years old at the time of the screening. * Subjects seeking improvement of décolleté wrinkles. Exclusion Criteria: * Any previous surgery, including plastic surgery or permanent surgical implant in the treatment area. * Previous treatment with collagen fillers, calcium hydroxylapatite, and/or long-lasting hyaluronic acid (HA) fillers in the décolleté, or with other HA fillers in the décolleté. * Previous treatment with botulinum toxin, ablative or fractional laser, microdermabrasion, microneedling, chemical peels, and/or non-invasive skin tightening in the décolleté.

Locations (9)

Clinical Testing of Beverly Hills, Merz Investigational Site #0010395

Beverly Hills, California, United States

Facial Plastic Surgery, Merz Investigational Site #0010463

Redondo Beach, California, United States

Cosmetic Laser Dermatology, Merz Investigational Site #0010321

San Diego, California, United States

Outcomes

Primary Outcomes

Percentage of Responders on Merz Aesthetic Scale (MAS) Décolleté Wrinkles - at Rest at Week 24

The percentage of responders (responder rate) was defined as the percentage of subjects achieving greater than or equal to (\>=) 1-point improvement on MAS décolleté wrinkles-at Rest from baseline to Week 24 as assessed by the blinded evaluator. Responder rate was assessed using MAS-at rest scale, where 0 = no wrinkles, 1 = mild wrinkles, 2 = moderate wrinkles, 3 = severe wrinkles, 4 = very severe wrinkles. Higher score indicated the worse outcome. This analysis was done using multiple imputation method to impute missing values.

Time frame: Week 24

Secondary Outcomes

Percentage of Responders on MAS Décolleté Wrinkles - Dynamic at Week 24

The percentage of responders (responder rate) was defined as the percentage of subjects achieving \>= 1-point improvement on MAS décolleté wrinkles-Dynamic from baseline to Week 24 as assessed by the blinded evaluator. Responder rate was assessed using MAS-Dynamic scale, where 0 = no wrinkles, 1 = mild wrinkles, 2 = moderate wrinkles, 3 = severe wrinkles, 4 = very severe wrinkles. Higher score indicated the worse outcome. This analysis was done using multiple imputation method to impute missing values.

Time frame: Week 24

Percentage of Subjects With Any Improvement on Investigator Global Aesthetic Improvement Scale (iGAIS) at Week 24

Improvement is defined as a rating of +1 (Improved), +2 (Much improved) or +3 (Very much improved). Treating investigators used iGAIS, where - 3 = very much worse, - 2 = much worse, - 1 = worse, 0 = no change, + 1 = improved, + 2 = much improved, + 3 = very much improved. Higher score indicated aesthetic improvement.

Time frame: Week 24

Percentage of Subjects With Any Improvement on Subject Global Aesthetic Improvement Scale (sGAIS) at Week 24

Improvement is defined as a rating of +1 (Improved), +2 (Much improved) or +3 (Very much improved). Subjects used the sGAIS, where - 3 = very much worse, - 2 = much worse, - 1 = worse, 0 = no change, + 1 = improved, + 2 = much improved, + 3 = very much improved. Higher score indicated aesthetic improvement.

Data from ClinicalTrials.gov

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