Evaluation of Radiesse® Dermal Filler for Hand Rejuvenation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-04-30

Brief Summary

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The purpose of this study is to assess the safety and effectiveness of Radiesse® Injectable Dermal Filler for hand treatment.

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Detailed Description

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This is a prospective, randomized, masked, controlled study to investigate the effectiveness of Radiesse® Dermal Filler for hand treatment.

This is a prospective, randomized, masked, controlled study to investigate the effectiveness of Radiesse® Dermal Filler for hand treatment, comprised of a 3-month main study followed by an open-label extension (OLEX) study through 12 months. At 3 months, untreated controls received Radiesse Dermal Filler for hand treatment and were followed for the remainder of the study. All study subjects were eligible for retreatment 6 months after initial treatment, and all subjects were followed through 12 months from study enrollment in the OLEX.

Conditions

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Aging Hands

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Radiesse Injectable Dermal Filler

Device: Radiesse Injectable Dermal Filler

Group Type EXPERIMENTAL

Radiesse Injectable Dermal Filler

Intervention Type DEVICE

Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Delayed Treatment

Cross over to treatment with Radiesse Injectable Dermal Filler at 3 Months

Group Type ACTIVE_COMPARATOR

Radiesse Injectable Dermal Filler

Intervention Type DEVICE

Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Interventions

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Radiesse Injectable Dermal Filler

Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Has right and left hands with a rating of 3 or 4 on the Busso Hand Volume Severity Scale (BHVSS) as determined by the treating physician
* Signs a written informed consent
* Understands and accepts the obligation not to receive any other procedures in the dorsum of the hands through 12 month follow up
* Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits

Exclusion Criteria

* Has history of hypertropic scarring
* Has a known bleeding disorder or receiving medication that will increase the risk of bleeding as the result of injection
* Has a known hypersensitivity to any of the components of Radiesse or local anesthesia
* Has used predefined products or treatments on the dorsum of the hand within last 4 weeks or intends to use during study
* Has had any dermal fillers or surgery in the dorsum of the hand
* Is a female of child bearing potential and not using medically effective birth control or is pregnant or lactating

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes