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Safety and Efficacy Study of Dysport RU and Glabellar Lines

NCT01333397 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2022-09-27

Study results available
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Summary

The primary objective is to assess the dose response versus placebo of a single treatment of Dysport RU (Dysport RU, Ready to Use, for injection), for the improvement in appearance of moderate to severe glabellar lines at maximum frown.

Conditions

  • Glabellar Frown Lines

Interventions

BIOLOGICAL

Botulinum toxin type A

I.M. (in the muscle) injection on day 1 (single treatment cycle)

BIOLOGICAL

Botulinum toxin type A

I.M. on day 1 (single treatment cycle)

DRUG

Placebo

I.M. on day 1 (single treatment cycle)

Sponsors & Collaborators

Principal Investigators

  • Ipsen Study Director · Ipsen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • France
  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT01333397 on ClinicalTrials.gov