Rifaximin Treatment of Papulopustular Rosacea

Rifaximin Treatment of Papulopustular Rosacea: Double- Blinded, Placebo-Controlled, Crossover Study

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01359228

Enrollment

Registered

2011-05-24

Start date

2013-04-30

Completion date

2014-12-31

Last updated

2014-04-28

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

Conditions

Rosacea

Keywords

Rosacea

Brief summary

The purpose of this study is to determine the effects of rifaximin on skin symptoms in patients with rosacea by double-blinded, placebo-controlled, crossover study.

Detailed description

100 patients will be randomized into two groups. Group A will receive one rifaximin 550 mg tablet three times a day (1650 mg/day) for 14 days, and after a 4-week washout period, receive one placebo tablet three times a day for 14 days. Group B will receive placebo first, and then rifaximin with the same dosage schedule to Group A. Assessments will be performed before application and 4 weeks after the last dosage, for both of rifaximin and placebo.

Interventions

DRUGRifaximin (XIFAXAN)

Rifaximin (XIFAXAN®) 1650 mg/day (550 mg tablet three times a day) for 14 days

DRUGPlacebo

Placebo 1 tablet three times a day for 14 days.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Males and females * \> 18 years of age with rosacea defined as: * 3-40 papules/pustules and \< 2 nodules, * A score of 2-4 on the Investigator Global Assessment

Exclusion criteria

* Untreated pancreatic insufficiency * Crohn's disease * Ulcerative colitis * Active celiac disease by clinical history * End stage renal failure * Less than 18 years old * Pregnancy or positive pregnancy test * Rosacea subtype 1 (no papules ) * Topical or oral antibiotics within 4 weeks * Acne treatments within 4 weeks prior to randomization * Systemic retinoids within 90 days * Topical or systemic corticosteroids 4 weeks prior to randomization

Design outcomes

Primary

Measure	Time frame	Description
Investigator's Global Assessment (IGA) Score of Rosacea Symptoms	14 days	A response to treatment is defined as the achievement of an IGA score of '0 or 1' at endpoint for moderate to severe patients and achievement of an IGA score of '0' at endpoint for mild patients.

Secondary

Measure	Time frame	Description
Achieving an IGA score of 0.	14 days	Percentage of patients achieving an IGA score of '0' (cleared).

Countries

United States

Outcome results

None listed

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