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Study to Compare 2 Botulinum Type A Toxins in the Treatment of Glabellar Frown Lines

NCT04763265 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2025-03-18

Study results available
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Summary

The purpose of the study is to provide preliminary comparative data on BoNT/A-DP versus Botox Cosmetic. Subsequently the sample size is primarily based on clinical judgement and practical considerations.

Conditions

  • Frown Lines

Interventions

BIOLOGICAL

Botulinum toxin A "BoNT/A-DP"

To assess the efficacy of treatment with BoNT/A-DP in reducing the severity of glabellar frown lines at maximum frown.

BIOLOGICAL

Botulinum toxin A "Botox Cosmetics"

To assess the efficacy of treatment with Botox Cosmetics in reducing the severity of glabellar frown lines at maximum frown.

Sponsors & Collaborators

  • Hugel

    collaborator INDUSTRY

  • Croma-Pharma GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-24
Primary Completion
2020-11-05
Completion
2021-02-01
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Canada

Study Locations

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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 NCT04763265 on ClinicalTrials.gov