Safety and Efficacy of NT 201, Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines

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

PHASE3

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-01-31

Brief Summary

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NT 201 is a Botulinum toxin type A preparation free of complexing proteins. Injected into the muscle, NT 201 causes a reversible local relaxation of the injected muscle. Botulinum toxin type A is widely used for aesthetic treatment of mimic wrinkles. This study will investigate the safety and efficacy of NT 201 in the treatment of glabellar frown lines.

Detailed Description

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Conditions

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Healthy

Keywords

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Treatment of glabellar frown lines

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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NT 201

A Botulinum neurotoxin type A, free of complexing proteins

Detailed described in study protocol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* moderate to severe glabellar frown lines at maximum frown ((severity score of 2 or 3 on Facial Wrinkle Scale(FWS)as assessed by the investigator's rating: 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe'
* Stable medical condition
* Age: between 18 and 65 years (inclusively)

Exclusion Criteria

* Previous treatment with Botulinum toxin of any serotype in the upper third part of the face within the last 6 month
* Previous treatment with biodegradable fillers in the glabellar area within the last 12 month
* Previous insertion of permanent material in the glabellar area, including fat graft (regardless of the time between previous treatment and this study)
* Any surgery in the glabellar area including surgical removal of the corrugator, procerus, or depressor supercilii muscles or a combination of these, or scars in the glabellar area
* Any other planned cosmetic procedure in the upper third part of the face during the trial period
* Inability to substantially lessen glabellar frown lines even by physically spreading them apart
* Marked facial asymmetry or ptosis of eyelid and/or eyebrow
* History of facial nerve palsy
* Any infection in the area of the injection sites

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthias Imhof, MD

Role: PRINCIPAL_INVESTIGATOR

Ästhetische Dermatologie, Medico Palais Bad Soden

Locations

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Dr. Matthias Imhof, Medico Palais Bad Soden

Bad Soden, Hesse, Germany

Site Status

Countries

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Germany

References

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Imhof M, Kuhne U. A Phase III Study of IncobotulinumtoxinA in the Treatment of Glabellar Frown Lines. J Clin Aesthet Dermatol. 2011 Oct;4(10):28-34.

Reference Type RESULT

PMID: 22010053 (View on PubMed)

Other Identifiers

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2008-000549-73

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MRZ 60201 GL_3001

Identifier Type: -

Identifier Source: org_study_id