MedTrace Logo

Head-to-Head Comparison of All Botulinum Neurotoxin Type A Products for Glabellar Rhytides

NCT06448676 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-09-19

No results posted yet for this study

Summary

Study Type: This is a multicenter, triple-blind, randomized controlled trial.

Purpose: The goal of this clinical trial is to compare the effectiveness and safety of all five commercially available Botulinum Neurotoxin Type A (BoNT-A) products for treating glabellar rhytides, commonly known as frown lines. This study is designed to provide comprehensive data on how these treatments compare in terms of improving frown lines and the duration of their effects.

Main Questions the Study Aims to Answer:

Which BoNT-A product provides the longest lasting effect on reducing glabellar rhytides? How do these products compare in terms of safety and the occurrence of side effects?

Participant Tasks:

Women aged 18 years or older with moderate to severe glabellar lines will participate.

Participants will receive injections of a BoNT-A product into specific facial muscles.

They will need to take weekly photographs using their smartphones to document changes in their frown lines.

These photos will be securely sent to our research team for analysis. Participants will complete questionnaires at the start and end of the study to assess their satisfaction, quality of life, and any changes in their condition.

Comparison Group:

Researchers will compare participants receiving different types of BoNT-A products to see which one is more effective at reducing frown lines and maintaining these effects over time.

The safety profiles of these products will also be compared to determine which has the fewest and least severe side effects.

This study aims to fill important gaps in our understanding of Botulinum Neurotoxin Type A treatments, guiding more effective clinical decisions and improving patient outcomes.

Conditions

  • Wrinkle

Interventions

DRUG

Botulinum toxin type A

Head-to-head comparison of all commercially available botulinum neurotoxin type A products

Sponsors & Collaborators

  • Universitair Medical Centrum Groningen

    collaborator UNKNOWN

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • Jan de Lange, MD DMD PhD · Amsterdam University Medical Centers

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-10-01
Completion
2025-11-01
FDA Drug
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06448676 on ClinicalTrials.gov