NCT04763265

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

A Double-Blinded, Randomized, Controlled Study to Compare the Efficacy, Time to Onset, and Duration of Effect of Botulinum Type A Toxins in the Treatment of Glabellar Frown Lines

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Croma-Pharma GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This will be a multi-center, randomized, double-blind, comparator-controlled study. The study will take place in the EU, US and Canada. To allow all subjects to profit from treatment and to obtain adequate data for BoNT/A DP treatment, the study will be comprised of a double-blinded treatment comparing BoNT/A-DP with Botox Cosmetic (ratio 1:1). Primary and secondary endpoints will compare efficacy, safety and subject satisfaction after a single treatment of the investigational BoNT/A DP to an existing commercially available product (Botox Cosmetic). Two hundred subjects will be enrolled, which should allow for a precise estimate of response rate and for post-hoc sensitivity analyses. The duration of study participation for each subject will be up to 18 weeks, to include screening (maximum of 2 weeks; re-screening will not be permitted), and a single treatment (comprised of one injection at five injection points) of BoNT/A-DP (Group A) or Botox Cosmetic (Group B) followed by six efficacy and safety follow-up visits. A total of 200 subjects will be randomized 1:1 to Group A or Group B at Baseline. Both investigators and subjects will be blinded to treatment. Investigators and subjects will evaluate the severity of glabellar lines independently.

Conditions

• Frown Lines

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-06-24
• Primary completion: 2020-11-05
• Completion: 2021-02-01
• First posted: 2021-02-21
• Last updated: 2025-03-18
• Results posted: 2025-03-18

Locations

5 sites across 3 countries: United States, Austria, Canada

Regulatory

• FDA-regulated drug study