Growing research from independent laboratories provide an association between mycobacteria
and sarcoidosis. More recent immunologic and molecular studies demonstrate immune responses
to mycobacteria virulence factors. We hypothesize that sarcoidosis pathogenesis reflects an
immune response against metabolically-active mycobacterial species. The purpose of this
study is to assess if administration of anti-mycobacterial drug therapy will aid in
resolution of cutaneous sarcoidosis lesions.
Inclusion Criteria:
1. Patients with sarcoidosis as defined by the ATS/ERS/WASOG statement on sarcoidosis as
defined by the clinical presentation consistent with sarcoidosis, biopsy finding
granulomas, and no alternative for the cause of the granulomas, such as tuberculosis
2. Patients must have chronic cutaneous skin lesions with or without taking chronic
therapy (corticosteroids, methotrexate (max 10mg/week), azathioprine,
hydroxychloroquine, cyclophosphamide, minocycline, doxycycline and chloroquine), in
which the dose has not been altered in the 2 months prior to starting the study.
3. Subject has a diagnosis of cutaneous sarcoidosis for greater than 6 months with a
Sarcoidosis Activity and Severity Index assessment score of at least 4. Diagnosis can
be made by either:
- Skin lesions characteristic of sarcoidosis and a biopsy showing granulomas with
no evidence of mycobacteria, fungus, or malignancy.
- A biopsy that does not show granulomas, but the patient has characteristic skin
lesions and history of clinical features suggesting sarcoidosis (previous biopsy
revealing noncaseating granuloma, bilateral hilar adenopathy, erythema nodosum,
uveitis, raised ACE level, BAL lymphocytosis (CD4: CD8>3. 5), panda/lambda sign on
gallium scan)
- Accepted clinical variants include, but are not necessarily limited to the
following:
- lupus pernio
- nodular
- subcutaneous
- annular
- angiolupoid
- plaque
- papular
- lichenoid
- psoriasiform
- For purposes of this study "moderate to severe cutaneous sarcoidosis" is defined
as the presence of sarcoidal skin lesions with any of the following features:
- At least 5 easily visible facial lesions, or
- Disease which involves > 3% BSA, or
- Disease which confers functional impairment (e. g. nasal or visual field
obstruction), or
- Disease which confers significant symptoms of itching and/or pain.
4. If female, subject is either not of childbearing potential, defined as postmenopausal
for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral
oophorectomy, or hysterectomy), or is using one of the following methods of birth
control for the duration of the study and 90 days after study completion:
- condoms, sponge, foams, jellies, diaphragm, or intrauterine device
- contraceptives (oral or parenteral) for three months prior to study drug
administration
- a vasectomized sole partner
- Females of childbearing potential must have a negative serum pregnancy test at
screening visit.
Exclusion Criteria:
1. No consent/inability to obtain consent.
2. Age less than 18 years of age.
3. Inability to obtain biopsy or draw blood.
4. CPK, ALT or AST >5 times upper limit of normal (ULN)
5. Pregnancy or breast feeding.
6. Current use of medications metabolized by rifampin (See Appendix).
7. Allergy to macrolides, quinolones or rifamycins.
8. Visual Impairment as defined by differentiating colors.
9. Family or personal history of long QT syndromes.
10. Patients receiving another interventional investigational drug within the 30 days
prior to dosing
11. Use of any investigational medication within the past 28 days prior to study
enrollment.
12. Subject has been hospitalized for infection or received IV antibiotics within the
previous 2 months prior to baseline.
13. Subject has a history of tuberculosis at anytime or close contact with a person with
active tuberculosis within the previous 6 months, or persistent or active infections
requiring hospitalization or treatment with IV antibiotics, IV antiretrovirals, or IV
antifungals within 30 days of baseline, OR oral antibiotics, antivirals, or
antifungals for purpose of treating infection, within 14 days of baseline.
14. Evidence of other active skin diseases or skin infections during screening that may
interfere with evaluation of sarcoidosis.
15. Subject has an active infection requiring systemic antibiotics at time of screening
16. Subject has a history of listeriosis, treated or untreated tuberculosis, exposure to
individuals with tuberculosis.
17. Subject has a variant of sarcoidosis that is not amenable to study evaluation, in the
absence of chronic indurated lesions, such as:
- Acute, "benign" sarcoid associated with erythema nodosum
- Acute iritis
- Ichthyosiform sarcoidosis
- Hypo- or hyperpigmented macular sarcoidosis
- Ulcerative sarcoidosis
- Erythroderma
- Alopecia
18. Patients otherwise unsuitable for participation in the opinion of the investigator
