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Neurotoxin

QM1114-DP for Frown 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

Study Summary

This trial is testing a new treatment for people with moderate to severe wrinkles between their eyebrows. The goal is to improve the appearance of the wrinkles.

Who is the study for?
This trial is for men and women over 18 with moderate to severe frown lines, as judged by both themselves and the investigator. It's not for those who are pregnant, breastfeeding, planning to conceive during the study, or have used botulinum toxin in facial areas within the last 9 months.Check my eligibility
What is being tested?
The trial is testing QM1114-DP against a placebo to see if it improves the appearance of frown lines. Participants will be randomly assigned to receive either QM1114-DP or a placebo without knowing which one they're getting.See study design
What are the potential side effects?
While specific side effects aren't listed here, treatments like QM1114-DP can typically cause reactions at the injection site, muscle weakness near treated areas, headache, or flu-like symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Responders in QM1114-DP versus Placebo using the Global Aesthetic Improvement Scale (GAIS) at maximum frown at Month 1

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active arm - QM1114-DPActive Control1 Intervention
a Botulinum Toxin Type A (BoNT-A)
Group II: Inactive arm - PlaceboPlacebo Group1 Intervention
A buffered solution,

Find a Location

Who is running the clinical trial?

Q-Med ABLead Sponsor
80 Previous Clinical Trials
12,545 Total Patients Enrolled
Galderma R&DLead Sponsor
298 Previous Clinical Trials
60,210 Total Patients Enrolled

Media Library

QM1114-DP (Neurotoxin) Clinical Trial Eligibility Overview. Trial Name: NCT05146999 — Phase 3
Frown Lines Research Study Groups: Active arm - QM1114-DP, Inactive arm - Placebo
Frown Lines Clinical Trial 2023: QM1114-DP Highlights & Side Effects. Trial Name: NCT05146999 — Phase 3
QM1114-DP (Neurotoxin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05146999 — Phase 3
Frown Lines Patient Testimony for trial: Trial Name: NCT05146999 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial active in more than one state?

"Aesthetic Solutions, PA in Chapel Hill, North carolina, Skin Wellness Dermatology in Homewood, Alabama and Moradi MD in Vista, California are a few of the sites running this study; there are 5 other locations as well."

Answered by AI

Has Active arm - QM1114-DP received FDA approval?

"Since this is a Phase 3 trial, there is already some evidence of efficacy as well as multiple rounds of data supporting safety. Therefore, Active arm - QM1114-DP was given a score of 3 for safety."

Answered by AI

Does this experiment still require test subjects?

"The study, which was originally posted on May 9th, 2022 is currently looking for participants. The listing on clinicaltrials.gov was last updated on October 17th, 2022."

Answered by AI

How many individuals are currently signed-up to participate in this research?

"That is accurate. The clinical trial information available on clinicaltrials.gov shows that the study began recruiting on 5/9/2022 and was last updated on 10/17/2022. They are currently looking for 120 patients from 5 different locations."

Answered by AI

Who else is applying?

What state do they live in?
California
Texas
How old are they?
18 - 65
65+
What site did they apply to?
Moradi MD
Integrated Aesthetics
Galderma Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1

What questions have other patients asked about this trial?

If accepted, when would the trial begin?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

Deep lines since I was a teen. I have deep wrinkles in between by eyes that I feel make me look older than I am. I have used Botox before, but it only works for a very short period of time for me.
PatientReceived 2+ prior treatments
~41 spots leftby Apr 2025