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Rifaximin Treatment of Papulopustular Rosacea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01359228
Recruitment Status : Withdrawn
First Posted : May 24, 2011
Last Update Posted : April 28, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Rosacea Drug: Rifaximin (XIFAXAN) Drug: Placebo Phase 2

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rifaximin Treatment of Papulopustular Rosacea: Double- Blinded, Placebo-Controlled, Crossover Study
Study Start Date : April 2013
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea
Drug Information available for: Rifaximin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Investigator's Global Assessment (IGA) Score of Rosacea Symptoms [ Time Frame: 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 Outcome Measures :
  1. Achieving an IGA score of 0. [ Time Frame: 14 days ]
    Percentage of patients achieving an IGA score of '0' (cleared).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01359228


Locations
United States, California
UCSF, CTSI, 12-Moffitt/Long Hospital
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Martin Steinhoff, MD, Ph.D. UCSF, Dept. of Dermatology
More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01359228     History of Changes
Other Study ID Numbers: Salix Rifaximin Study
First Posted: May 24, 2011    Key Record Dates
Last Update Posted: April 28, 2014
Last Verified: April 2014

Keywords provided by University of California, San Francisco:
Rosacea

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Rifaximin
Rifamycins
Anti-Infective Agents
Gastrointestinal Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents