Rifaximin Treatment of Papulopustular Rosacea

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01359228
First received: April 1, 2011
Last updated: April 25, 2014
Last verified: April 2014
  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:


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).


Enrollment: 0
Study Start Date: April 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01359228     History of Changes
Other Study ID Numbers: Salix Rifaximin Study
Study First Received: April 1, 2011
Last Updated: April 25, 2014
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 July 31, 2014