A Multicenter, Randomized, Double-Blind, Active-Controlled (BOTOX®) and Placebo-Controlled Study to Evaluate the Efficacy and Safety of QM1114-DP for the Treatment of Moderate to Severe Glabellar Lines in Subjects of Chinese Origin

Galderma R&D6 sites in 1 country605 target enrollmentJuly 29, 2022

ConditionsModerate to Severe Glabellar Lines

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Moderate to Severe Glabellar Lines
Sponsor: Galderma R&D
Enrollment: 605
Locations: 6
Primary Endpoint: The composite responder rate will be evaluated at Month 1 using the GL-ILA and the GL-SLA at maximum frown.
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase 3, multicenter, randomized, double-blind, active-controlled and placebo-controlled study to evaluate the efficacy and safety of 50 units (U) of QM1114-DP for the treatment of moderate to severe GL in male and female subjects of Chinese origin. The study has been designed to test the superiority of QM1114-DP compared to placebo, and the non-inferior efficacy of QM1114-DP compared to onabotulinumtoxinA (BOTOX®), in improving the appearance of moderate to severe GL.

Registry

clinicaltrials.gov

Start Date

July 29, 2022

End Date

June 15, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Galderma R&D

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female subjects of Chinese origin from ≥18 to ≤65 years of age.
•Moderate to severe GL (grade of 2 or 3 on the 4-point Photographic Scale ranging from 0 \[none\] to 3 \[severe\]) at maximum frown as assessed by the Investigator (GL-ILA).
•Moderate to severe GL (grade of 2 or 3 on the Static 4-point Categorical Scale ranging from 0 \[no wrinkles\] to 3 \[severe wrinkles\]) at maximum frown as assessed by the subject (GL-SLA).
•Female of non-childbearing potential (i.e., post-menopausal \[absence of menstrual bleeding for 1 year prior to screening, without any other medical reason\], or has undergone hysterectomy or bilateral oophorectomy). OR Female of childbearing potential with a negative pregnancy test at screening and baseline, and agrees to use a highly effective and approved contraceptive method for the duration of the study. A highly effective method of contraception is defined as: Bilateral tubal ligation; Combined (estrogen and progesterone containing) oral, intravaginal or transdermal contraceptives that inhibit ovulation as the primary mode of action, on a stable dose for at least 28 days prior to screening visit; Intrauterine device (IUD) inserted at least 28 days prior to screening visit; Intrauterine hormone-releasing system; Partner vasectomized for at least three months prior to screening visit; Progestogen-only oral, injectable or implantable contraceptives that inhibit ovulation as the primary mode of action, on a stable dose for at least 28 days prior to screening visit; or Strict abstinence (i.e., refraining from heterosexual intercourse for the duration of the subject's participation in the study).
•Time and ability to complete the study and comply with instructions.
•Understands the study requirements and signed the informed consent form (ICF).

Exclusion Criteria

•Previous use of any botulinum neurotoxin (BoNT) in facial areas within 9 months prior to study treatment.
•Anticipated need for treatment with BoNT of any serotype for any reason during the study (other than the study products).
•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 study products (QM1114-DP or BOTOX®) or any other BoNT serotype.
•Inability to substantially lessen GL by physically spreading them apart, as determined by the Investigator.
•Clinically significant abnormal lab finding(s) at screening, or clinically significant abnormal focused physical exam finding(s) at screening or baseline visits, in the opinion of the Investigator.
•Excessive skin laxity in the treatment area or periorbital area.
•Previous use of any hyaluronic acid soft tissue augmentation therapy in the glabella or forehead area within 6 months before baseline.
•Previous soft tissue augmentation with any permanent (non-biodegradable such as silicone, polyacrylamide, etc.) or semi-permanent (i.e., calcium hydroxylapatite, poly-L-Lactic acid or polymethyl-methacrylate) product; lifting threads, or autologous fat in the treatment area.
•History, presence, or predisposition of eyelid or eyebrow ptosis, amblyopia, or previous surgery around the eye that may lead to the above events, as determined by the Investigator.

Outcomes

Primary Outcomes

The composite responder rate will be evaluated at Month 1 using the GL-ILA and the GL-SLA at maximum frown.

Time Frame: 1 month

A composite responder is defined as a subject who achieves a score of 0 or 1 in GL severity and at least 2 grades improvement from baseline on both the GL-ILA and GLSLA scales concurrently.