NCT00720980

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2008

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

Same day

First QC Date

July 21, 2008

Last Update Submit

April 29, 2024

Conditions

Keywords

granuloma annulare, ROM

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Response to the standard treatment of granuloma annulare.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Medical Center

Detroit, Michigan, 48202, United States

Location

Related Publications (1)

  • Duarte AF, Mota A, Pereira MA, Baudrier T, Azevedo F. Generalized granuloma annulare--response to doxycycline. J Eur Acad Dermatol Venereol. 2009 Jan;23(1):84-5. doi: 10.1111/j.1468-3083.2008.02707.x. Epub 2008 Apr 1. No abstract available.

    PMID: 18384540BACKGROUND

MeSH Terms

Conditions

Granuloma Annulare

Condition Hierarchy (Ancestors)

Necrobiotic DisordersCollagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesGranulomaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Iltefat H Hamzavi, MD

    Henry Ford Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dermatologist

Study Record Dates

First Submitted

July 21, 2008

First Posted

July 23, 2008

Study Start

May 1, 2008

Primary Completion

May 1, 2008

Study Completion

July 1, 2008

Last Updated

April 30, 2024

Record last verified: 2024-04

Locations