CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 251 enrolled
Drug / intervention
Botulinum Toxin A +2 moredrug
Likely dose
Botulinum Toxin A 20 Unitsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02677805
NCT02677805Phase 3Completed
CompareCT.gov

Randomized Double Blind Phase 3 Study to Assess the Efficacy and Safety of BoNT/A-DP in the Treatment of Glabellar Lines in Comparison With Placebo Followed by an Open Label Extension Study

Croma-Pharma GmbH·interventional·Posted Feb 9, 2016·Updated Mar 19, 2025

In Brief

A Phase 3 clinical trial evaluating Botulinum Toxin A, Placebo, and 1 other intervention for Glabellar Frown Lines. Completed, enrolled 251 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlabellar Frown Lines
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 9, 2016
Enrollment StartMar 30, 2016
Primary CompletionSep 15, 2016
Study CompletionNov 3, 2017
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 10.4 years ago

Interventions

Botulinum Toxin Adrug

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

Placebodrug

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

Botulinum Toxin A - Open Labeldrug

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