MedTrace Logo

CD5024 1% [Ivermectin 1%] Cream Versus Metronidazole 0.75% Cream in Papulopustular Rosacea (PPR) Study

NCT01493947 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 962

Last updated 2015-10-28

Study results available
· View outcomes & findings →

Summary

Study objectives:

* To compare efficacy and safety of Ivermectin 1% cream versus metronidazole 0.75% cream in subjects with papulopustular rosacea after 16-week topical treatment.
* And to compare, for subjects initially successfully treated by 16 weeks treatment, Ivermectin 1 % cream versus metronidazole 0.75% cream during a 36-week extension period by assessing, the time of first relapse, the relapse rate, and the number of days free of treatment

Conditions

  • Papulopustular Rosacea

Interventions

DRUG

Ivermectin 1% cream

Ivermectin 1% cream applied once daily on the face during 16-week plus 36-week extension period.

DRUG

Metronidazole 0.75% cream

Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.

Sponsors & Collaborators

  • Galderma R&D

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Bulgaria
  • Czechia
  • France
  • Germany
  • Hungary
  • Poland
  • Romania
  • Russia
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

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 NCT01493947 on ClinicalTrials.gov