Study of 0444 Gel in the Treatment of Inflammatory Lesions of Rosacea

Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study of 0444 Gel

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01016782

Enrollment

867

Registered

2009-11-19

Start date

2008-01-31

Completion date

2009-07-31

Last updated

2014-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Rosacea

Keywords

Inflammatory Rosacea, Rosacea

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.

Interventions

DRUG0444

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Reduction in the number of papules and pustules from Baseline to End of Treatment	70 Days

Secondary

Measure	Time frame
Reduction in the Investigator's Global Evaluation, Clear or Almost Clear	70 Days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026