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 at month 1

Awards & highlights

Pivotal Trial

Summary

This trial aims to see how well QM1114-DP works in improving the look of deep frown lines between the eyebrows by relaxing the muscles in that area.

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.

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.

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 ~ at month 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at month 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and at month 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) at Month 1

Secondary study objectives

Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12

Percentage of Participants Reporting Onset of Treatment Effect Using the Diary Card

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.