What side effects are associated with this type of intervention?

The most common treatment for frown lines involves the use of botulinum toxin, which inhibits acetylcholine release at the neuromuscular junction. Known side effects of botulinum toxin treatments include localized pain at the injection site, swelling, redness, and bruising. Some patients may experience headaches, flu-like symptoms, or temporary eyelid drooping. Rarely, there can be more serious side effects such as muscle weakness or allergic reactions.

What prior FDA approvals exist?

Botulinum toxin type A, such as onabotulinumtoxinA (commonly known as Botox), has received FDA approval for the treatment of frown lines. These treatments work by inhibiting the release of acetylcholine at the neuromuscular junction, leading to temporary muscle paralysis and reduction of frown lines. Other formulations like abobotulinumtoxinA (Dysport) and incobotulinumtoxinA (Xeomin) are also used for similar indications. These treatments are effective in reducing the appearance of moderate to severe glabellar lines by targeting the underlying muscle activity.

What other types of research exist?

Promising novel alternatives to QM1114-DP for treating frown lines include DWP450 (a novel botulinum neurotoxin type A) and Dyston® (a biosimilar abobotulinumtoxinA). Both have demonstrated efficacy and safety in recent clinical trials, making them viable options for patients considering treatment in 2024.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month

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,

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatment for frown lines involves the use of botulinum toxin, which works by inhibiting the release of acetylcholine at the neuromuscular junction. This inhibition prevents muscle contraction, leading to temporary muscle paralysis. For patients with frown lines, this is significant because it directly addresses the underlying cause of these lines—excessive nerve stimulation and muscle activity. By reducing muscle contractions, botulinum toxin effectively smooths out the skin, leading to an improved aesthetic appearance and reducing the perception of anger or annoyance often associated with frown lines.

Botulinum toxin in women's health: An update.Botulinum Neurotoxin Type A in Neurology: Update.Botulinum toxin: mechanisms of action.

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

300 Previous Clinical Trials

60,345 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

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