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

Merz Pharmaceuticals

Status: Active, not recruiting

Conditions: Décolleté Wrinkles

Treatments: Device: Treatment with diluted Radiesse

Study type: Interventional

Funder types: Industry

Identifiers

NCT05163353

M930521003

Details and patient eligibility

About

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

Enrollment: 152 patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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152 participants in 2 patient groups

Treatment with diluted Radiesse

Experimental group

Description:

Injection of Décolleté Wrinkles with diluted Radiesse

Treatment:

Device: Treatment with diluted Radiesse

Delayed treatment with diluted Radiesse

Other group

Description:

Delayed injection of Décolleté Wrinkles with diluted Radiesse

Treatment:

Device: Treatment with diluted Radiesse