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Completed

NCT Number: NCT04247074

Treatment of Moderate to Severe Lateral Canthal Lines and Glabellar Lines Alone or in Combination

This study is designed to evaluate the safety and efficacy of a single dose of QM1114-DP for the treatment of moderate to severe LCL and moderate to severe GL, alone or in combination.

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Key information

Conditions

Glabellar Frown Lines (GL) Lateral Canthal Lines (LCL)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bertucci Medspa, Inc, Woodbridge, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female 18 years of age or older.
  • Moderate to severe LCL at maximum smile as assessed by the Investigator.
  • Moderate to severe LCL at maximum smile as assessed by the subject.
  • Moderate to severe GL at maximum frown as assessed by the Investigator.
  • Moderate to severe GL at maximum frown as assessed by the subject

Exclusion criteria

  • Previous use of any Botulinum toxin in facial areas within 9 months prior to study treatment.
  • Female who is pregnant, breast feeding, or intends to conceive a child during the study.
  • Known allergy or hypersensitivity to any component of the investigational product (QM1114-DP).

Treatment and study plan

botulinum toxin neuromodulator

Biological

QM1114-DP will be injected into either the LCL, GL, or both the LCL and GL

Other names: QM1114-DP

Placebo

Biological

Placebo will be injected into either the LCL, GL, or both the LCL and GL

Primary outcomes

  1. Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown

    Time frame: Month 1

    Investigator 4-point Photographic Scale of Glabellar Line Severity represents the severity of GL from none (grade 0), mild (grade 1), moderate (grade 2) to severe (grade 3). Each grade is depicted by an individual photograph and a descriptive text. The Investigators used the 4-point Photographic Scale for direct, live comparison with the subject's face at maximum frown.

    Subjects made their assessment of glabellar line severity independently of the Investigator's assessment. Subjects were asked to evaluate their GL at maximum frown by grading the GL severity from none (grade 0, smooth skin), mild (grade 1, fairly smooth skin), moderate (grade 2, frown lines) to severe (grade 3, deep frown lines).

  2. Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Lateral Canthal Lines Investigator and Subject Assessments at Maximum Smile

    Time frame: Month 1

    Investigator 4-point Photographic Scale of Lateral Canthal Line represents LCL severities from none (grade 0), mild (grade 1), moderate (grade 2), to severe (grade 3). Each grade is also depicted by an individual photograph and descriptive text. The Investigators used the LCL-ILA for direct, live comparison with the subject's face for grading LCL severity. Left and right LCL were assessed at maximum smile.

    Subject 4-point Photographic Scale of Lateral Canthal Line Severity represents LCL severities from Level 0, Level 1, Level 2, to Level 3. Each grade is also depicted by an individual photograph and descriptive text. Subjects made their assessments independently of the Investigator's assessment. Subjects evaluated their LCL severity (left and right side separately) at maximum smile.

Secondary outcomes

  1. Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown

    Time frame: Month 1

  2. Percentage of Subjects Who Achieve Grade 0 or 1 in Lateral Canthal Line Investigator Scale at Maximum Smile.

    Time frame: Month 1

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of QM1114-DP for the Treatment of Moderate to Severe Lateral Canthal Lines and Glabellar Lines Alone or in Combination

Acronym: READY-3

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jan 29, 2020
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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