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OpenTrials
Completed

NCT Number: NCT04225260

Long-term Treatment of Moderate to Severe Glabellar Lines and Lateral Canthal Lines

This is a phase 3, multicenter, open-label study to evaluate the safety of QM1114-DP for the long term treatment of moderate to severe Glabellar (Frown) Lines (GL) and Lateral Canthal Lines (Crow's Feet and LCL).

Completed

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Key information

Conditions

Glabellar Lines Lateral Canthal Lines

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jose Raul Montes Eyes & Facial Rejuvenation LLC, San Juan, Puerto Rico

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 at least 18 years of age.

Exclusion criteria

  • Previous use of any Botulinum toxin in facial areas within 9 months prior to study treatment.
  • Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than the investigational product).
  • 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 neuromodulator

Biological

A dose of QM1114-DP will be injected in the GL area and in the LCL area.

Other names: QM1114-DP

Primary outcomes

  1. Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the GL Investigator Scales at Maximum Frown

    Time frame: Week 4

    4-point scale

  2. Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the LCL Investigator Scales at Maximum Smile

    Time frame: Week 4

    4-point scale

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

A Multicenter, Open-Label Study to Evaluate the Safety of QM1114-DP for the Long-term Treatment of Moderate to Severe Glabellar Lines and Lateral Canthal Lines

Acronym: READY-4

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 13, 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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