Clinical trial NCT05163353: Evaluation of the Effectiveness and Safety of Diluted RADIESSE® in the Treatment of Décolleté Wrinkles
Official title: Prospective, Multicenter, Controlled, Evaluator-blind, Randomized Study to Investigate the Effectiveness and Safety of Diluted RADIESSE® for Treatment of Décolleté Wrinkles
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Décolleté Wrinkles
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2021-12-20
Enrollment: 152
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Responders on Merz Aesthetic Scale (MAS) - at rest
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Responders on Merz Aesthetic Scale (MAS) - dynamic
timeFrame: Week 24
measure: Percentage of Participants with Improvement on Subject Global Aesthetic Improvement Scale (sGAIS)
timeFrame: Week 24
measure: Percentage of Participants with Improvement on Investigator Global Aesthetic Improvement Scale (iGAIS)
timeFrame: Week 24
measure: Number of Participants with TEAEs related to treatment
timeFrame: Baseline to week 84
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Clinical Testing of Beverly Hills, Merz Investigational Site #0010395
state: California
city: Redondo Beach
country: United States
facility: Facial Plastic Surgery, Merz Investigational Site #0010463
state: California
city: San Diego
country: United States
facility: Cosmetic Laser Dermatology, Merz Investigational Site #0010321
state: California
city: Santa Monica
country: United States
facility: Private Practice, Merz Investigational Site #0010299
state: California
city: Vista
country: United States
facility: Face Beautiful Inc, Merz Investigational Site #0010358
state: California
city: Coral Gables
country: United States
facility: Skin Associates of South Florida, Merz Investigational Site #0010101
state: Florida
city: West Palm Beach
country: United States
facility: Research Institute of the Southeast, LLC, Merz Investigational Site #0010420
state: Florida
city: Alpharetta
country: United States
facility: The Graivier Center, Merz Investigational Site #0010464
state: Georgia
city: Nashville
country: United States
facility: Nashville Center for Laser and Facial Surgery, Merz Investigational Site #0010353
state: Tennessee
Study officials:
References: