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Dermal Filler
Assess Aesthetic Improvement With QM1114-DP in Subjects With Moderate to Severe Lateral Canthal Lines and Glabellar Lines
Phase 3
Waitlist Available
Research Sponsored by Q-Med AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing QM1114-DP, a treatment to improve the appearance of wrinkles between the eyebrows and around the eyes. It works by making the skin look smoother.
Eligible Conditions
- Crow's Feet
- Frown Lines
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Responders in QM1114-DP versus Placebo using the Global Aesthetic Improvement Scale (GAIS) at maximum frown at Month 1
Responders in QM1114-DP versus Placebo using the Global Aesthetic Improvement Scale (GAIS) at maximum smile at Month 1
Side effects data
From 2023 Phase 3 trial • 132 Patients • NCT051469997%
COVID-19
6%
Headache
4%
Upper respiratory tract infection
4%
Basal cell carcinoma
3%
Sinusitis
3%
Procedural pain
2%
Contusion
2%
Fall
2%
Injection site bruising
2%
Dermatitis contact
1%
Injection site pain
1%
Limb injury
1%
Tonsillitis
1%
Transient ischaemic attack
1%
Gastroenteritis viral
1%
Hand fracture
1%
Hordeolum
1%
Influenza
1%
Postoperative wound infection
1%
Muscle strain
1%
Skin laceration
1%
Wrist fracture
1%
Diarrhoea
1%
Irritable bowel syndrome
1%
Drug hypersensitivity
1%
Ureterolithiasis
1%
Hypertension
1%
Tension headache
1%
Dyspepsia
1%
Conjunctivitis
1%
Rib fracture
1%
Tooth fracture
1%
Oropharyngeal pain
1%
Conjunctivitis bacterial
1%
Hydronephrosis
1%
Wound infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Comparator: Placebo
Experimental: QM1114-DP
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: QM1114-DPExperimental Treatment1 Intervention
QM1114-DP
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
QM1114-DP
2022
Completed Phase 3
~770
Find a Location
Who is running the clinical trial?
Q-Med ABLead Sponsor
80 Previous Clinical Trials
12,652 Total Patients Enrolled
Galderma R&DLead Sponsor
302 Previous Clinical Trials
60,643 Total Patients Enrolled