Granuloma AnnulareNCT00720980
Granuloma Annulare Treated With Rifampin, Ofloxacin, and Minocycline Combination Therapy
An observational study of Granuloma Annulare, run by Henry Ford Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Granuloma Annulare
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jul 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients with granuloma annulare who are resistent to the standard treatment.
Who cannot join
- Response to the standard treatment of granuloma annulare.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- What previous treatment options have been or/are currently being used?
- How long did the patient take the treatment for?
- Was the patient able to discontinue or become less dependent on prior treatment?
- Was the disease process slowed by the treatment?;
- Were there any side effects that the patient experienced with treatment?
- Conditions
- Granuloma Annulare
- Keywords
- granuloma annulare, ROM
- Medical subject headings
- Granuloma Annulare
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Granuloma AnnulareStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iltefat Hamzavi, Henry Ford Health System
- Investigators
- Iltefat H Hamzavi, MD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00720980
- Sponsor's protocol ID
- IRB5074
- Status last verified
- Apr 2024
- First submitted
- 21 Jul 2008
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18384540
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Granuloma Annulare Treated With Rifampin, Ofloxacin, and Minocycline Combination Therapy
- ClinicalTrials.gov ID
- NCT00720980
- Acronym / sponsor ID
- IRB5074
- Conditions
- Granuloma Annulare
- Keywords
- granuloma annulare, ROM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- May 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 23 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- What previous treatment options have been or/are currently being used?
- How long did the patient take the treatment for?
- Was the patient able to discontinue or become less dependent on prior treatment?
- Was the disease process slowed by the treatment?;
- Were there any side effects that the patient experienced with treatment?
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients with granuloma annulare who are resistent to the standard treatment.
Key exclusion criteria (1 listed)
- Response to the standard treatment of granuloma annulare.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Background: PubMed 18384540Duarte 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iltefat H Hamzavi, MD principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Granuloma Annulare, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00720980, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.