Study with two injections (one injection with placebo or drug, one injection with drug) to investigate the efficacy and safety of NT 201 (active ingredient: Botulinum (neuro)toxin type A, free from complexing proteins) in the combined treatment of wrinkles in the upper face.

A prospective, randomized, double-blind, placebo-controlled, multicenter study with an open-label extension period to investigate the efficacy and safety of NT 201 in the combined treatment of upper facial lines (horizontal forehead lines, glabellar frown lines, and lateral periorbital lines) - n/a

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005887-20-DE

Enrollment

150

Registered

2012-05-15

Start date

2012-07-17

Completion date

Unknown

Last updated

2014-04-14

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

Conditions

Upper facial lines (horizontal forehead lines, glabellar frown lines, and lateral periorbital lines) MedDRA version: 14.1 Level: PT Classification code 10040954 Term: Skin wrinkling System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Trade Name: Xeomin Product Name: NT 201 Product Code: NT 201 Pharmaceutical Form: Powder for solution for injection CAS Number: 93384-43-1 Current Sponsor code: NT 101 Other descriptive name: Botulinu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Outpatients (male or female) 18 years of age or older. • Calculated cut-off score below 0 in evaluation based on the Freiburg Life Quality Assessment - ‘Lebensqualität, Haut und Kosmetik’ Questionnaire [FLQA-k]). • HFL, GFL, and symmetrical LPL of moderate to severe intensity at maximum contraction as assessed by the investigator according to the Merz Aesthetics Scales. • Stable medical condition. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 144 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6

Exclusion criteria

Exclusion criteria: Main Period: • Previous treatment with Botulinum toxin of any serotype in the forehead, glabellar, and/or periorbital area within the last 6 months before injection. • Previous treatment with any facial cosmetic procedure (e.g. dermal filling,chemical peeling, photo rejuvenation) in the forehead, glabellar, and/or periorbitalarea within the last 8 months before injection. • Any previous insertion of permanent material in the forehead, glabellar, and/or periorbital area (regardless of the time between previous treatment and this study). • Planned treatment with Botulinum toxin of any serotype in the face during the study period. • Any other planned facial cosmetic procedure in the face during the study period. • Very severe lines (HFL, GFL, and/or LPL) at maximum contraction as assessed by the investigator according to the Merz Aesthetics Scales. • Inability to substantially lessen UFL (HFL, GFL, LPL) by physically spreading them apart. • Any surgery or scars in the forehead, glabellar, or periorbital area. • Marked facial asymmetry. • Eyelid ptosis. • Marked brow ptosis. • History of facial nerve palsy. • Any infection and/or inflammation at the planned injection points.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the efficacy and safety of 54 to 64 Units of NT 201 intramuscularly administered in subjects with moderate to severe upper facial lines.;Secondary Objective: To evaluate the safety of the combined treatment;Primary end point(s): Main period only: • Response at maximum contraction for the three treated areas, as assessed by the investigator according to the Merz Aesthetics Scales, i.e. a score of none (0) or mild (1). • Response at maximum contraction simultaneously for all three treatment areas, as assessed by the investigator according to the Merz Aesthetics Scales, i.e. a sum score of 3 or lower.;Timepoint(s) of evaluation of this end point: Day 30	—

Measure

Time frame

Main Objective: To investigate the efficacy and safety of 54 to 64 Units of NT 201 intramuscularly administered in subjects with moderate to severe upper facial lines.;Secondary Objective: To evaluate the safety of the combined treatment;Primary end point(s): Main period only: • Response at maximum contraction for the three treated areas, as assessed by the investigator according to the Merz Aesthetics Scales, i.e. a score of none (0) or mild (1). • Response at maximum contraction simultaneously for all three treatment areas, as assessed by the investigator according to the Merz Aesthetics Scales, i.e. a sum score of 3 or lower.;Timepoint(s) of evaluation of this end point: Day 30

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Secondary

Measure	Time frame
Secondary end point(s): Main period: • Response at maximum contraction and at rest at days 8, 60, 90, and 120 for the three treated areas, as assessed by the investigator’s rating and by the subject according to the Merz Aesthetics Scales, i.e. a score of none (0) or mild (1). • Response at maximum contraction and at rest at days 8, 30, 60, 90, and 120 for the three treated areas, as assessed independently from each other by the investigator’s and the subject’s rating according to the Merz Aesthetics Scales, i.e. an improvement of at least 1 point. • Response at day 30 for the overall appearance of the upper face, as assessed independently from each other by the investigator and the subject according to the Global Impression of Change Scale, i.e. a score of much improved (+2) or very much improved (+3). • Onset of effect after each treatment for all three treated areas. Open-Label Extension (OLEX) period: • Response at maximum contraction and at rest at days 8, 30, 75, and 120 for the three treated areas, as assessed by the investigator’s rating and by the subject according to the Merz Aesthetics Scales, i.e. a score of none (0) or mild (1). • Response at maximum contraction and at rest at days 8, 30, 75, and 120 for the three treated areas, as assessed independently from each other by the investigator’s and subject’s rating according to the Merz Aesthetics Scales, i.e. an improvement of at least 1 point. • Response at day 30 for the overall appearance of the upper face, as assessed independently from each other by the investigator and the subject according to the Global Impression of Change Scale, i.e. a score of much improved (+2) or very much improved (+3). • Onset of effect after each treatment for each of the three treated areas.;Timepoint(s) of evaluation of this end point: see E 5.2	—

Measure

Time frame

Secondary end point(s): Main period: • Response at maximum contraction and at rest at days 8, 60, 90, and 120 for the three treated areas, as assessed by the investigator’s rating and by the subject according to the Merz Aesthetics Scales, i.e. a score of none (0) or mild (1). • Response at maximum contraction and at rest at days 8, 30, 60, 90, and 120 for the three treated areas, as assessed independently from each other by the investigator’s and the subject’s rating according to the Merz Aesthetics Scales, i.e. an improvement of at least 1 point. • Response at day 30 for the overall appearance of the upper face, as assessed independently from each other by the investigator and the subject according to the Global Impression of Change Scale, i.e. a score of much improved (+2) or very much improved (+3). • Onset of effect after each treatment for all three treated areas. Open-Label Extension (OLEX) period: • Response at maximum contraction and at rest at days 8, 30, 75, and 120 for the three treated areas, as assessed by the investigator’s rating and by the subject according to the Merz Aesthetics Scales, i.e. a score of none (0) or mild (1). • Response at maximum contraction and at rest at days 8, 30, 75, and 120 for the three treated areas, as assessed independently from each other by the investigator’s and subject’s rating according to the Merz Aesthetics Scales, i.e. an improvement of at least 1 point. • Response at day 30 for the overall appearance of the upper face, as assessed independently from each other by the investigator and the subject according to the Global Impression of Change Scale, i.e. a score of much improved (+2) or very much improved (+3). • Onset of effect after each treatment for each of the three treated areas.;Timepoint(s) of evaluation of this end point: see E 5.2

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Countries

Germany, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026