A Double-blinded Evaluation of Safety and Efficacy of Hylaform and Hylaform Plus Compared to Zyplast.

NCT ID: NCT00288470

Last Updated: 2015-03-18

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

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2003-08-31

Brief Summary

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A clinical study to investigate the safety and efficacy of Hylaform and Hylaform Plus for correction of facial wrinkles.

Detailed Description

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Conditions

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Facial Wrinkles

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Hylaform, Hylaform Plus (hylan B gel)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* bilateral nasolabial folds with severity score 3 or 4 on the 6-point grading scale

Exclusion Criteria

* pregnant/lactating women
* patients who previously received permanent facial implants or using ovet-the-counter products
Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Genzyme Corporation

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Genzyme, a Sanofi Company

Other Identifiers

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HYLA-001-01

Identifier Type: -

Identifier Source: org_study_id

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