A Study to Determine if RADIESSE® Dilute Treatment in Décolleté of Adult Women Affects Radiographic Imaging Assessments

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-22

Study Completion Date

2026-10-31

Brief Summary

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The primary purpose of this study is to determine if treatment with Radiesse dilute in the décolleté interferes with radiographic imaging of the breast tissue.

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Detailed Description

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Conditions

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Décolleté Wrinkles

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiesse

Participants will receive three injections of Radiesse in the Décolleté at Weeks 1, 7 and 13.

Group Type EXPERIMENTAL

Radiesse

Intervention Type DEVICE

Radiesse injections diluted 1:2 with sterile saline.

Interventions

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Radiesse

Radiesse injections diluted 1:2 with sterile saline.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Participants seeking improvement of moderate to severe décolleté wrinkles.
* Participant is willing to undergo up to three bilateral mammograms and up to four bilateral ultrasound procedures.

Exclusion Criteria

* Any pre-existing serious disease or disorder of the breast tissue that may confound interpretation of radiographic and/or ultrasound imaging (example., participants with a history of breast cancer or an immediate family history of breast cancer \[that is., mother, sister, and/or daughter\], pathogenic or likely pathogenic breast cancer (BRCA) gene variant, calcifications and/or microcalcifications detected on previous mammography \[up to three years prior to study start, if available\]).
* Present uncontrolled malignant disease.
* Any condition that would caution against receiving additional radiation exposure in the breasts.
* Any previous surgery, including plastic surgery or permanent surgical implant, or previous non-surgical treatment in the planned in the treatment area and in the breasts.

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No