Moderate to Severe Glabellar LinesPhase 3NCT05463965
A Study to Evaluate the Efficacy and Safety of QM1114-DP for the Treatment of Moderate to Severe Glabellar Lines
A Phase 3 study testing QM1114-DP and OnabotulinumtoxinA in people with Moderate to Severe Glabellar Lines, run by Galderma R&D at 6 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Moderate to Severe Glabellar Lines
- What is being tested?
- QM1114-DP and OnabotulinumtoxinA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 605 participants
- Where
- 6 sitesChina
- Study dates
- 29 Jul 2022to 15 Jun 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
- Planned facial surgery, eye surgery (including LASIK procedure) or facial aesthetic procedures (e.g., ablative skin resurfacing, laser treatment, micro needling, chemical peel, BoNT treatment, or dermal fillers) in the face during the study period.
- History or presence of facial nerve palsy, or any medical condition that may put the subject at increased risk with exposure to BoNT including diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function.
- Use of medications that affect neuromuscular transmission such as curare-like depolarizing agents, lincosamides, polymyxins, anticholinesterases, and aminoglycoside antibiotics.
- Subject with bleeding disorder or subject currently using anticoagulants.
- Subject has any prior or current psychiatric illness (e.g., Psychosis, depression, anxiety), alcohol or drug abuse, or is taking antidepressant, anxiolytic, or antipsychotic medication that, in the Investigator's opinion, could affect the subject's safety and/or participation in the study.
- Other concurrent medical conditions, therapy, or other condition that, in the Investigator's opinion, would interfere with the evaluation of the study medication, safety or efficacy, and/or put the subject at risk if he/she participates in the study.
- Participation in an investigational device or drug study within 30 days prior to study treatment or plans to enroll in any other investigational study during participation in this study.
- Study site personnel, close relatives of the study site personnel (e.g., parents, children, siblings, or spouse), employees or close relatives of employees at the Sponsor company.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Beijing Tongren Hospital, CMU
Beijing, 100730
Peking University First Hospital
Beijing
Xiangya 3rd Hospital
Changsha, Hunan
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, 510317
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
Tianjin University General Hospital
Tianjin
About this study
Official title: 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
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
- Being tested
- QM1114-DP, OnabotulinumtoxinA, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QM1114-DPBiological
Intramuscular injection
OnabotulinumtoxinABiological
Intramuscular injection
PlaceboBiological
Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Single injection with QM1114-DP in glabellar lines Receives: Biological: QM1114-DP |
| Active-Controlled Group | Active comparator | Single injection with BOTOX® in glabellar lines Receives: Biological: OnabotulinumtoxinA |
| Placebo-Controlled Group | Placebo comparator | Single injection with placebo in glabellar lines Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start29 Jul 2022
- Primary completion29 Jan 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Glabellar LinesStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 605 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yan Wu, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463965
- Sponsor's protocol ID
- 43QMCH1908
- Status last verified
- Apr 2023
- First submitted
- 14 Jul 2022
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05463965
- Acronym / sponsor ID
- 43QMCH1908
- Conditions
- Moderate to Severe Glabellar Lines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 605 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 29 Jan 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Biological: QM1114-DPSingle injection with QM1114-DP in glabellar lines |
| Active-Controlled Group | Active comparator | Biological: OnabotulinumtoxinASingle injection with BOTOX® in glabellar lines |
| Placebo-Controlled Group | Placebo comparator | Biological: PlaceboSingle injection with placebo in glabellar lines |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QM1114-DPIntramuscular injection | Biological | Treatment Group |
| OnabotulinumtoxinAIntramuscular injection | Biological | Active-Controlled Group |
| PlaceboIntramuscular injection | Biological | Placebo-Controlled Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Wu principal investigator
Peking University First Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QM1114-DP and OnabotulinumtoxinA in people with Moderate to Severe Glabellar Lines, run by Galderma R&D at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.