Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds in Persons of Color

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

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-02-29

Brief Summary

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Post marketing study to assess the likelihood of hypertropic scarring, keloid formation and hyper- or hypopigmentation in patients with Fitzpatrick Skin Types IV, V, and VI receiving nasolabial fold treatment with Radiesse® Injectable Dermal Filler

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Detailed Description

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Conditions

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Nasolabial Folds

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

Group Type EXPERIMENTAL

Radiesse® Injectable Dermal Filler

Intervention Type DEVICE

Calcium hydroxylapatite particles suspected in an aqueous based gel carrier

Interventions

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Radiesse® Injectable Dermal Filler

Calcium hydroxylapatite particles suspected in an aqueous based gel carrier

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Is at least 18 years of age.
* Has Fitzpatrick Skin Type IV, V, or VI.
* Understands and accepts the obligation not to receive any other procedures or treatments in the nasolabial fold for 6 months.

Exclusion Criteria

* Has history of hyper- or hypo-pigmentation in the nasolabial folds, keloid formation, or hypertrophic scarring.
* Has a known bleeding disorder or is receiving drug therapy that could increase the risk of bleeding.
* Has nasolabial folds that are too severe to be corrected in one treatment session.
* Has received any dermal filler or other injections, grafting or surgery in either nasolabial fold.
* Is pregnant, lactating, or not using acceptable contraception.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes