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ULTRA I: Safety and Efficacy Study of the Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines and Lateral Canthal Lines) in Subjects With Moderate to Severe Upper Facial Lines

Sponsor
Merz Pharmaceuticals GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT04594213
Collaborator
(none)
362
Enrollment
12
Locations
4
Arms
19.5
Actual Duration (Months)
30.2
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 (Upper Facial Lines [UFL]): 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 :
362 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 :
Sep 23, 2020
Actual Primary Completion Date :
Apr 15, 2021
Actual Study Completion Date :
May 9, 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): GFL/HFL; Placebo: LCL

    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 treatment-emergent adverse events (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 (score 2) to severe (score 3) intensity at maximum contraction as assessed by the investigator and subject according to Merz Aesthetics Scales [MAS].

    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 The Clinical Testing Center of Beverly Hills, Merz Investigational Site #0010395 Encino California United States 91436
    2 Steve Yoelin MD Medical Asscociates, Merz Investigational Site #0010435 Newport Beach California United States 92663
    3 Cosmetic Laser Dermatology, Merz Investigational Site #0010321 San Diego California United States 92121
    4 AboutSkin Research, Merz Investigational Site #0010103 Greenwood Village Colorado United States 80111
    5 Center for Dermatology and Dermatologic Surgery, Merz Investigational Site #0010170 Washington District of Columbia United States 20037
    6 Center for Clinical and Cosmetic Research, Merz Investigational Site #0010453 Aventura Florida United States 33180
    7 Steven Fagien, Merz Investigation Site #0010449 Boca Raton Florida United States 33431
    8 Center For Cosmetic Dermatologic Surgery, Merz Investigational Site #0010105 Metairie Louisiana United States 70006
    9 Aesthetic Plastic Surgery Center, Merz Investigational Site #0010405 New York New York United States 10028
    10 Kane Plastic Surgery, Merz Investigational Site #0010297 New York New York United States 10065
    11 Sadick Research Group, Merz Investigational Site #0010448 New York New York United States 10075
    12 Tennessee Clinical Research Center, Merz Investigational Site #0010097 Nashville Tennessee United States 37215

    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:
    NCT04594213
    Other Study ID Numbers:
    • M602011071
    First Posted:
    Oct 20, 2020
    Last Update Posted:
    May 24, 2022
    Last Verified:
    May 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 May 24, 2022