Rifaximin Treatment of Papulopustular Rosacea

Rosacea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01359228
• Other study ID #: Salix Rifaximin Study
• Status: Withdrawn
• Phase: Phase 2
• First received: April 1, 2011
• Last updated: April 25, 2014
• Start date: April 2013
• Est. completion date: December 2014

Study information

• Verified date: April 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rosacea

Intervention

Drug:
• Rifaximin (XIFAXAN)
Rifaximin (XIFAXAN®) 1650 mg/day (550 mg tablet three times a day) for 14 days
• Placebo
Placebo 1 tablet three times a day for 14 days.

Locations

Country	Name	City	State
United States	UCSF, CTSI, 12-Moffitt/Long Hospital	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator's Global Assessment (IGA) Score of Rosacea Symptoms	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.	14 days	No
Secondary	Achieving an IGA score of 0.	Percentage of patients achieving an IGA score of '0' (cleared).	14 days	No