Rifaximin Treatment of Papulopustular Rosacea

NCT01359228 | Withdrawn Phase 2

• 1 other identifier: Salix Rifaximin Study
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Rosacea

Keywords

Rosacea

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Achieving an IGA score of 0.

  14 days

Study Arms (2)

Rifaximin

EXPERIMENTAL

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

Drug: Rifaximin (XIFAXAN)

sugar pill

PLACEBO COMPARATOR

Placebo 1 tablet three times a day for 14 days.

Drug: Placebo

Interventions

Rifaximin (XIFAXAN) DRUG

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

Also known as: XIFAXAN

Rifaximin

Placebo DRUG

Placebo 1 tablet three times a day for 14 days.

sugar pill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF, CTSI, 12-Moffitt/Long Hospital

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Rosacea

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Martin Steinhoff, MD, Ph.D.

  UCSF, Dept. of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2011
• First Posted: May 24, 2011
• Study Start: April 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 28, 2014

Record last verified: 2014-04

Locations

US (1)