NCT01016782

Brief Summary

The aim of this trial is to assess the efficacy of Metronidazole Topical Gel 1% in the Treatment of Inflammatory Lesions of Rosacea. Treatment medication will be administered as follows: A thin film of gel will be applied and rubbed into the entire face once daily for a period of 70 days.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
867

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2008

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 19, 2009

Completed
Last Updated

July 4, 2014

Status Verified

July 1, 2014

Enrollment Period

1.5 years

First QC Date

November 17, 2009

Last Update Submit

July 2, 2014

Conditions

Inflammatory Rosacea

Keywords

Inflammatory RosaceaRosacea

Outcome Measures

Primary Outcomes (1)

  • Reduction in the number of papules and pustules from Baseline to End of Treatment

    70 Days

Secondary Outcomes (1)

  • Reduction in the Investigator's Global Evaluation, Clear or Almost Clear

    70 Days

Study Arms (3)

Test

EXPERIMENTAL

Test product that contains active pharmaceutical ingredient

Drug: 0444

Reference

ACTIVE COMPARATOR

Reference product that contains active pharmaceutical ingredient

Drug: 0444

Vehicle

PLACEBO COMPARATOR

Placebo that contains no active pharmaceutical ingredient

Drug: 0444

Interventions

0444DRUG

A thin film of gel will be applied and rubbed into the entire face once daily for a period of 70 days

ReferenceTestVehicle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of rosacea
  • Good health with the exception of rosacea
  • Papsules and pustules minimum and maximum requirements

You may not qualify if:

  • Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
  • Subjects who have any systemic or dermatological disorders with the exception of rosacea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Angela C Kaplan

    Fougera Pharmaceuticals Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2009

First Posted

November 19, 2009

Study Start

January 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

July 4, 2014

Record last verified: 2014-07