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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-10

Study Completion Date

2025-06-11

Brief Summary

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

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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

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment with diluted Radiesse

Injection of Décolleté Wrinkles with diluted Radiesse

Group Type EXPERIMENTAL

Treatment with diluted Radiesse

Intervention Type DEVICE

Injection of Décolleté Wrinkles with diluted Radiesse

Delayed treatment with diluted Radiesse

Delayed injection of Décolleté Wrinkles with diluted Radiesse

Group Type OTHER

Treatment with diluted Radiesse

Intervention Type DEVICE

Injection of Décolleté Wrinkles with diluted Radiesse

Interventions

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Treatment with diluted Radiesse

Injection of Décolleté Wrinkles with diluted Radiesse

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No