Rifaximin Treatment of Papulopustular Rosacea - Full Text View

Sponsor:	University of California, San Francisco
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT01359228

Purpose

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.

Condition	Intervention	Phase
Rosacea	Drug: Rifaximin (XIFAXAN) Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Rifaximin Treatment of Papulopustular Rosacea: Double- Blinded, Placebo-Controlled, Crossover Study

Resource links provided by NLM:

MedlinePlus related topics: Rosacea

Drug Information available for: Rifaximin

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Investigator's Global Assessment (IGA) Score of Rosacea Symptoms [ Time Frame: 14 days ] [ Designated as safety issue: No ]
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 Outcome Measures:

Achieving an IGA score of 0. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Percentage of patients achieving an IGA score of '0' (cleared).

Estimated Enrollment:	100
Study Start Date:	June 2011
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Rifaximin rifaximin (XIFAXAN®) 1650 mg/day (550 mg tablet three times a day) for 14 days	Drug: Rifaximin (XIFAXAN) Rifaximin (XIFAXAN®) 1650 mg/day (550 mg tablet three times a day) for 14 days Other Name: XIFAXAN
Placebo Comparator: sugar pill Placebo 1 tablet three times a day for 14 days.	Drug: Placebo Placebo 1 tablet three times a day for 14 days.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01359228

Contacts

Contact: Martin Steinhoff, MD, Ph.D.	415-885-7622	steinhoffm@derm.ucsf.edu
Contact: Elaine Yu	415-885-7622	yue@derm.ucsf.edu

Locations

United States, California
UCSF, CTSI, 12-Moffitt/Long Hospital	Not yet recruiting
San Francisco, California, United States, 94143
Contact: Deanna Sheeley 415-353-1330 dsheeley@gcrc.ucsf.edu

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator:

Martin Steinhoff, MD, Ph.D.

UCSF, Dept. of Dermatology

More Information

No publications provided

Responsible Party:	Martin Steinhoff, M.D., Professor of Dermatology and Surgery, UCSF, Department of Dermatology
ClinicalTrials.gov Identifier:	NCT01359228 History of Changes
Other Study ID Numbers:	Salix Rifaximin Study
Study First Received:	April 1, 2011
Last Updated:	May 23, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:

Rosacea

Additional relevant MeSH terms:

Rosacea
Skin Diseases
Rifaximin
Anti-Infective Agents

Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 23, 2012