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Evaluation of Radiesse® Dermal Filler for Hand Treatment

NCT ID: NCT01832090

Last Updated: 2017-10-19

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

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-09-30

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.

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, 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

Keywords

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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 Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine-HCl)

Group Type EXPERIMENTAL

Radiesse® Injectable Dermal Filler

Intervention Type DEVICE

Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.

Delayed Treatment

Untreated controls crossed over to treatment with Radiesse Dermal Filler mixed with 2% lidocaine-HCl (final concentration: 0.3% lidocaine) 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 rating of 2 or 3 on the Merz Hand Grading Scale (MHGS) as determined by a live, masked evaluator
* Is at least 18 years of age

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 received in past 6 months or plans to receive during the study dermal resurfacing procedure (chemical peel, dermabrasion, ablative laser resurfacing) or non-invasive skin tightening (Thermage®) in the dorsum of the hands
* Has received in past 2 weeks or plans to receive during the study prescription wrinkle therapies, topical steroids, skin irritating topical preparations, or pigmenting agents (self-tanning agents) in the dorsum of the hands
* Has had any dermal fillers or surgery in the dorsum of the hand
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merz Aesthetics Inc.

INDUSTRY

Sponsor Role collaborator

Merz North America, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Merz Investigative Site #004

San Diego, California, United States

Site Status

Merz Investigative Site #007

Vista, California, United States

Site Status

Merz Investigative Site #002

Garden City, New York, United States

Site Status

Merz Investigative Site #006

New York, New York, United States

Site Status

Merz Investigative Site #003

Nashville, Tennessee, United States

Site Status

Merz Investigative Site #001

Plano, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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P110607

Identifier Type: -

Identifier Source: org_study_id