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

Launched by MERZ NORTH AMERICA, INC. · Dec 6, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a treatment called diluted RADIESSE® for improving wrinkles on the décolleté area, which is the skin on the chest and neck. The goal is to see if this treatment can help reduce the appearance of these wrinkles in women aged 30 to 65 who are looking for a way to improve their skin’s appearance.

To participate, women must be within the specified age range and specifically seeking treatment for décolleté wrinkles. However, there are some important exclusions; for example, women who have had previous surgeries or other specific skin treatments in the décolleté area will not be eligible to join the trial. Participants can expect to receive the diluted RADIESSE® treatment and be monitored for its effects on their skin. This trial is currently active but not recruiting new participants, which means they are not looking for more volunteers at this time.

Gender

FEMALE

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.