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Granuloma Annulare Treated With Rifampin, Ofloxacin, and Minocycline Combination Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00720980
First Posted: July 23, 2008
Last Update Posted: July 23, 2008
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.
Information provided by:
Henry Ford Health System
  Purpose
Granuloma annulare is a benign, usually self-limiting, cutaneous dermatosis, which typically presents as asymptomatic, flesh-colored or red papules, frequently arranged in an annular pattern on the distal extremities. Although localized granuloma annulare is most commonly observed, a generalized or disseminated form can occur. The etiology of granuloma annulare is unknown, however, multiple inciting factors have been proposed. The purpose of the investigators is to review the outcomes of treatment of granuloma annulare (GA) resistant to standard regimens that resolved after a 3-months treatment course of monthly rifampin, ofloxacin, and minocycline (ROM) therapy, successfully used to treat paucibacillary leprosy, a disease with clinical and histopathologic similarity to GA.

Condition
Granuloma Annulare

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Granuloma Annulare Treated With Rifampin, Ofloxacin, and Minocycline Combination Therapy

Resource links provided by NLM:


Further study details as provided by Henry Ford Health System:

Enrollment: 6
Study Start Date: May 2008
Study Completion Date: July 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Detailed Description:

We will document the regimen treatment each patient has had and then review the following from the patient's chart to target our specific aims as outlined above.

  1. What previous treatment options have been or/are currently being used?
  2. How long did the patient take the treatment for?
  3. Was the patient able to discontinue or become less dependent on prior treatment?
  4. Was the disease process slowed by the treatment?;
  5. Were there any side effects that the patient experienced with treatment?
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The investigators reported 6 cases of resistant GA that resolved after a 3-month treatment course of monthly rifampin, ofloxacin, and minocycline (ROM) therapy. ROM therapy has been successfully used to treat patients with paucibacillary leprosy, which has morphologic and histologic similarities to GA.
Criteria

Inclusion Criteria:

  • Patients with granuloma annulare who are resistent to the standard treatment.

Exclusion Criteria:

  • Response to the standard treatment of granuloma annulare.
  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): NCT00720980


Locations
United States, Michigan
Henry Ford Medical Center
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Investigators
Principal Investigator: Iltefat H Hamzavi, MD Henry Ford Health System
  More Information

Publications:
Responsible Party: Iltefat H. Hamzavi, MD, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT00720980     History of Changes
Other Study ID Numbers: IRB5074
First Submitted: July 21, 2008
First Posted: July 23, 2008
Last Update Posted: July 23, 2008
Last Verified: May 2008

Keywords provided by Henry Ford Health System:
granuloma annulare, ROM

Additional relevant MeSH terms:
Granuloma
Granuloma Annulare
Lymphoproliferative Disorders
Lymphatic Diseases
Pathologic Processes
Necrobiotic Disorders
Collagen Diseases
Connective Tissue Diseases
Skin Diseases
Minocycline
Rifampin
Ofloxacin
Levofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antitubercular
Antitubercular Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors