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OpenTrials
Completed

NCT Number: NCT04249583

Treatment of Moderate to Severe Glabellar Lines

The objective of the study is to evaluate the efficacy and safety of a single dose of QM1114-DP compared to placebo for the treatment of moderate to severe GL.

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Key information

Conditions

Glabellar Frown Lines

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sweat Clinics of Canada, Toronto, 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 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) or any botulinum toxin serotype.

Treatment and study plan

botulinum toxin

Biological

neuromodulator to be injected in the GL region

Other names: QM1114-DP

Placebo

Biological

Placebo to be injected in the GL area

Primary outcomes

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

    Time frame: One Month

    The investigator and subject evaluate the subject's GL severity using a 4-grade scale (0 = none and 3 = severe)

Secondary outcomes

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

    Time frame: One Month

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 Glabellar Lines

Acronym: READY-1

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jan 31, 2020
Registry last updated
Jun 18, 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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