Trial Information

Intralesional Tetracycline Injection in the Treatment of Chalazia

Intralesional Tetracycline Injection in the Treatment of Chalazia

Authors: Bryan R. Costin, M.D. and Julian D. Perry, M.D.

Purpose: To investigate the therapeutic role of intralesional tetracycline injection when
compared to observation alone in the treatment of chalazia.

Introduction:

The tetracycline family includes tetracycline, doxycycline, and minocycline and this group
of compounds has a surprising number of properties including but not limited to antibiotic,
anti-malarial, anti-inflammatory, and antioxidant. Recent applications include uses both in
sclerotherapy in a wide variety of conditions from ganglions cysts to lymphangiomas to
ovarian cysts as well as in the reduction of hypertrophic scarring in rabbit models.1,2,3,4
In 2009, there were approximately 130 ongoing clinical trials studying this class of drugs
in an astounding variety of conditions from gingivitis to Alzheimer disease to brain
cancer.5

Chalazia are lipogranulomatous inflammatory lesions of the eyelid and are one of the most
common eyelid lesions and an extremely frequent presenting complaint to the ophthalmologist.
Chalazia often represent significant morbidity for the patients suffering from these
lesions because they are often recurrent, can be refractory to treatment, and are
disfiguring. Consequently, chalazia can also be a challenge to the ophthalmologist. Oral
tetracyclines have been shown to be effective in the treatment of ocular rosacea and
meibomian gland dysfunction (MGD), which are conditions commonly seen in association with
chalazia. The anti-inflammatory effect of the tetracyclines is thought to be beneficial in
rosacea and these drugs have been shown to alter the fatty acid composition of the lipid
layer of the tear film perhaps explaining their efficacy in MGD.6

Chalazia eventually resolve without intervention, but the process can take many months and
patients are frequently dissatisfied with observation as a treatment modality. Often
patients choose incision and drainage (I&D) of the lesion and this method is often
successful. Another treatment shown to be effective in chalazion treatment is the injection
of corticosteroid directly into the lesion, hence providing a depot anti-inflammatory
effect.7 However, unlike corticosteroids, the tetracyclines would offer antibiotic,
sclerosant, and lipid tear film augmentation, in addition to their anti-inflammatory effect.
Further, tetracyclines are FDA approved for the treatment of acne8, which is defined as
inflammation of pilosebaceous units9, and chalazia are defined as inflammation of sebaceous
glands10. With these multiple roles in mind, we propose injection of tetracycline into
chalazia to investigate its use as a multipurpose depot.

Methods:

After IRB approval, chalazia patients who wish to participate will be enrolled after the
risks, benefits, alternatives, and personnel have been explained to them and informed
consent has been obtained. A total of 80 subjects will be randomized to one of two groups:
40 subjects to observation alone and 40 subjects to treatment with an intralesional
injection of 0.05 mL 2% tetracycline solution. Subjects will be excluded from the study if
they are less than 18 years of age, are pregnant, have chalazia of less than 1 week
duration, have known allergies to tetracycline or its derivatives, or are currently taking
oral tetracyclines or have taken them in the past 3 months. Men, post-menopausal women, and
women who have undergone hysterectomy, bilateral oophorectomy, or bilateral salpingectomy
will not be tested for pregnancy. Pregnancy testing (urine or serum) will be performed on
women of childbearing age before enrollment and the results checked prior to the
administration of treatment.

For patients with multiple lesions, either on the same or opposite eyelids, only the most
symptomatic lesion will be enrolled in the study. Eyelid margin disease and ocular rosacea
will be documented at the time of enrollment. Subjects will then be examined at 4 weeks
(+/- 2 weeks) post-procedure follow-up visits where data regarding lesion size, including
color photography, lesion regression or recurrence, and a complete ophthalmic examination
will be recorded. If subjects fail to follow up at any of these visits, telephone
interviews will be conducted.

At the time of enrollment, the subject's date of birth, sex, race/ethnicity, and last
menstrual period will be determined as well as a gynecological history to determine need for
pregnancy testing. Data collection sheets will be used to record information. Also,
previous therapies including topical medications and previous surgeries will be reviewed. A
millimeter ruler will be used at the time of enrollment to determine the size of the lesion.
Lesion photographs will also be taken so that the independent chalazion photograph reviewer
will be able to grade degrees of improvement after treatment in a masked fashion.

When the procedure is performed, a variable pain scale will be used by the patient to
document their level of discomfort during the injection. At the return post procedure
visit, the lesion will be re-measured, the patient will be asked to grade the level of
improvement and a follow up photograph will be taken for use by the masked grader. All data
collection sheets and consents will be stored at the Cleveland Clinic in a secure location.
All other study data will be electronic and stored only on the secure Cleveland Clinic
server or Cleveland Clinic issued encrypted devices such as thumb drives and laptops. The
occurrence of any minor adverse or unexpected events will be reported to the principal
investigator. Any sentinel events will be reported to the IRB immediately.

A decrease in lesion size by two-thirds of greater as determined by either the clinician or
the masked photograph reviewer in either group will be considered improvement and if seen in
lesions injected with tetracycline it will constitute treatment success.