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ULTRA II: Safety and Efficacy Study of the Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines and Crows Feet) in Subjects With Moderate to Severe Upper Facial Lines.

Sponsor
Merz Pharmaceuticals GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT04622254
Collaborator
(none)
368
Enrollment
12
Locations
4
Arms
19.8
Actual Duration (Months)
30.7
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the safety and efficacy of NT 201 (active ingredient: Botulinum (neuro)toxin type A, free from complexing proteins) in the combined treatment of wrinkles in the upper face: Horizontal Forehead Lines [HFL], Glabellar Frown Lines [GFL], and Lateral Canthal Lines [LCL]). It is a prospective, randomized, double-blind, placebo-controlled, multicenter study with a placebo-control main period (MP) followed by an open-label extension period (OLEX).

Condition or Disease Intervention/Treatment Phase
  • Drug: NT 201
  • Drug: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
368 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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 Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines, and Lateral Canthal Lines)
Actual Study Start Date :
Nov 12, 2020
Actual Primary Completion Date :
Jun 16, 2021
Actual Study Completion Date :
Jul 8, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: MP: NT 201 (incobotulinumtoxinA): UFL

Intramuscular injection.

Drug: NT 201
Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
Other Names:
  • IncobotulinumtoxinA
  • Xeomin
  • Botulinum toxin type A (150 kiloDalton), free from complexing protein

    		•
    Experimental: MP: NT201 (incobotulinumtoxinA): LCL, Placebo: GFL/ HFL

    Intramuscular injection.

    Drug: NT 201
    Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
    Other Names:
  • IncobotulinumtoxinA
  • Xeomin
  • Botulinum toxin type A (150 kiloDalton), free from complexing protein

    • Drug: Placebo
    Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
    Placebo Comparator: MP: Placebo: UFL

    Intramuscular injection.

    Drug: Placebo
    Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
    Experimental: OLEX: NT201 (incobotulinumtoxinA): UFL

    Intramuscular injection.

    Drug: NT 201
    Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
    Other Names:
  • IncobotulinumtoxinA
  • Xeomin
  • Botulinum toxin type A (150 kiloDalton), free from complexing protein

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of Glabella Frown Line (GFL) responders at Day 30 [Day 30]

      Merz Aesthetics Scale (MAS - 5-point scale) will be used to identify responders

    2. Proportion of Horizontal Forehead Lines (HFL) responders at Day 30 [Day 30]

      Merz Aesthetics Scale (MAS - 5-point scale) will be used to identify responders

    3. Proportion of Lateral Canthal Lines (LCL) responders at Day 30 [Day 30]

      Merz Aesthetics Scale (MAS - 5-point scale) will be used to identify responders

    Secondary Outcome Measures

    1. Proportion of subjects with a score of 0 (no) or 1 (mild) on MAS for GFL at maximum contraction as assessed by the investigator at post-baseline visits of MP [Week 1, 4, 8, 12, and 16]

      Merz Aesthetics Scale (MAS) is a 5-point scale.

    2. Proportion of subjects with a score of 0 (no) or 1 (mild) on MAS for HFL at maximum contraction as assessed by the investigator at post-baseline visits of MP [Week 1, 4, 8, 12, and 16]

      Merz Aesthetics Scale (MAS) is a 5-point scale.

    3. Proportion of subjects with a score of 0 (no) or 1 (mild) on MAS for both left and right LCL at maximum contraction as assessed by the investigator at post-baseline visits of MP [Week 1, 4, 8, 12, and 16]

      Merz Aesthetics Scale (MAS) is a 5-point scale.

    4. Global Aesthetic Improvement Scale (GAIS) as assessed by the subject at Day 30 of MP [Day 30]

    5. Proportion of subjects with at least one-grade improvement from baseline to Day 30 of MP on MAS for GFL at maximum contraction as assessed by the investigator [Day 30]

      Merz Aesthetics Scale (MAS) is a 5-point scale.

    6. Proportion of subjects with at least one-grade improvement from baseline to Day 30 of MP on MAS for HFL at maximum contraction as assessed by the investigator [Day 30]

      Merz Aesthetics Scale (MAS) is a 5-point scale.

    7. Proportion of subjects with at least one-grade improvement from baseline to Day 30 of MP on MAS for both left and right LCL at maximum contraction as assessed by the investigator [Day 30]

      Merz Aesthetics Scale (MAS) is a 5-point scale.

    8. Global Aesthetic Improvement Scale (GAIS) as assessed by the investigator at Day 30 of MP [Day 30]

    9. Incidence of related treatment-emergent adverse events (TEAEs) in the MP [Baseline to week 16]

    10. Incidence of related TEAEs in the OLEX period [Week 16 to 48]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Outpatients (male or female) 18 years of age or older.

    • Horizontal forehead lines [HFL], glabellar frown lines [GFL], and symmetrical lateral canthal lines [LCL] of moderate to severe intensity at maximum contraction.

    Exclusion Criteria:

    • Previous treatment with botulinum neurotoxin [BoNT] of any serotype in the face within the last 12 months before injection.

    • Any facial cosmetic procedure within the last 12 months before baseline injection.

    • Previous treatment with any biodegradable filler in the face within the last 12 months before injection.

    • Any previous insertion of permanent material in the face (regardless of the time between previous treatment and this study).

    • Any medical condition that may put the subject at increased risk with exposure to NT201.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hautmedizin BadSoden, Merz Investigational Site #0490189 Bad Soden Germany 65182
    2 Privatpraxis fürr Dermatologie und Ästhetische Medizin, Merz Investigational Site #0490306 Berlin Germany 10707
    3 Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus, Merz Investigational Site #0490314 Bochum Germany 44793
    4 Praxis für Hautkrankheiten, Merz Investigational Site #0490375 Drensteinfurt Germany 48317
    5 Dermatology Dr. Hilton & Partner, Merz Investigational Site #0490381 Düsseldorf Germany 40212
    6 Universität Hamburg, Institut Für Biologie Und Molekularbiologie, Merz Investigational Site #0490095# Hamburg Germany 20146
    7 Derma Science, Merz Investigational Site #0490345 Hamburg Germany 22609
    8 Privatklinik Proebstle, Merz Investigational Site #0490284 Mannheim Germany 68161
    9 Privatpraxis für Dermatologie und Ästhetik, Merz Investigational Site #0490371 München Germany 80539
    10 Hautarztpraxis München-Neuhausen, Merz Investigational Site #0490372 München Germany 80636
    11 Haut- und Lasercentrum, Merz Investigational Site #0490362 Potsdam Germany 14467
    12 CentroDerm, Merz Investigational Site #0490367 Wuppertal Germany 42287

    Sponsors and Collaborators

    • Merz Pharmaceuticals GmbH

    Investigators

    • Study Director: Merz Medical Expert, Merz Aesthetics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Merz Pharmaceuticals GmbH
    ClinicalTrials.gov Identifier:
    NCT04622254
    Other Study ID Numbers:
    • M602011070
    • 2019-004113-13
    First Posted:
    Nov 9, 2020
    Last Update Posted:
    Jul 27, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Facies
    Botulinum Toxins
    Botulinum Toxins, Type A
    abobotulinumtoxinA
    incobotulinumtoxinA

    Study Results

    No Results Posted as of Jul 27, 2022