A Study to Evaluate the Efficacy and Safety of QM1114-DP for the Treatment of Moderate to Severe Glabellar Lines

NCT05463965 | Completed Phase 3

• 1 other identifier: 43QMCH1908
• Study Type: interventional
• Target: 605
• Locations: 1 country
• Sites: 6

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.

Conditions

Moderate to Severe Glabellar Lines

Outcome Measures

Primary Outcomes (1)

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

  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.

  1 month

Study Arms (3)

Treatment Group

EXPERIMENTAL

Single injection with QM1114-DP in glabellar lines

Biological: QM1114-DP

Active-Controlled Group

ACTIVE COMPARATOR

Single injection with BOTOX® in glabellar lines

Biological: OnabotulinumtoxinA

Placebo-Controlled Group

PLACEBO COMPARATOR

Single injection with placebo in glabellar lines

Biological: Placebo

Interventions

QM1114-DP BIOLOGICAL

Intramuscular injection

Treatment Group

OnabotulinumtoxinA BIOLOGICAL

Intramuscular injection

Active-Controlled Group

Placebo BIOLOGICAL

Intramuscular injection

Placebo-Controlled Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• Marked facial asymmetry, excessive dermatochalasis (i.e., excess of skin in eyelids), or marked periocular or eyebrow asymmetry.
• Presence of scar(s), piercing(s), or tattoo(s) (including microblading of eyebrow or eyeliner) in the treatment area or around the treatment area that, in the Investigator's opinion, may interfere with study evaluations.
• Presence of inflammation, active infection or skin disorder such as eczema, rosacea, facial psoriasis, herpes zoster etc., near or in the treatment area.
• Presence of cancerous or pre-cancerous lesions in the treatment area.
• History of other facial treatment, surgery or other aesthetic procedures (e.g., ablative skin resurfacing, laser treatment, micro needling, chemical peel) in the previous 12 months that, in the Investigator's opinion, could interfere with study injections and/or assessments.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (6)

Guangdong Second Provincial General Hospital

Guangzhou, Guangdong, 510317, China

Location

Xiangya 3rd Hospital

Changsha, Hunan, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Location

Beijing Tongren Hospital, CMU

Beijing, 100730, China

Location

Peking University First Hospital

Beijing, China

Location

Tianjin University General Hospital

Tianjin, China

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Yan Wu

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 19, 2022
• Study Start: July 29, 2022
• Primary Completion: January 29, 2023
• Study Completion: June 15, 2023
• Last Updated: October 12, 2023

Record last verified: 2023-04

Locations

CN (6)