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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00694148

Enrollment

108

Registered

2008-06-10

Start date

2008-05-31

Completion date

2009-01-31

Last updated

2012-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Treatment of glabellar frown lines

Brief summary

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.

Interventions

DRUGNT 201

A Botulinum neurotoxin type A, free of complexing proteins Detailed described in study protocol

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Investigator's assessment	4 weeks after initial injection session

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026