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Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study II

NCT02677805 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 251

Last updated 2025-03-19

Study results available
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Summary

The aim of this study is to assess the efficacy and safety of BoNT/a-DP in the treatment of glabellar lines in comparison with placebo, including efficacy after repeat treatments and long term safety.

Conditions

  • Glabellar Frown Lines

Interventions

DRUG

Botulinum Toxin A

Injection, 20 Units divided in five 0.1 mL i.m injections into the glabellar area

DRUG

Placebo

injection, sodium chloride 0.9% divided in five 0.1 mL i.m. injections into the glabellar area

DRUG

Botulinum Toxin A - Open Label

Open Label Extension Phase with Experimental Drug; Injection, 20 Units divided in five 0.1 mL i.m injections into the glabellar area

Sponsors & Collaborators

  • Croma-Pharma GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-03-30
Primary Completion
2016-09-15
Completion
2017-11-03

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02677805 on ClinicalTrials.gov