Intralesional Tetracycline Injection in the Treatment of Chalazia
NCT ID: NCT01763437
Last Updated: 2017-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
EARLY_PHASE1
INTERVENTIONAL
2014-03-31
2015-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Chalazion Conservative Treatment Trial
NCT01230593
Safety and Efficacy Study of SUN 131 TDS as Compared to Placebo TDS in Adult Patients With a Chalazion
NCT02338648
Safety and Efficacy Study of SUN-131 Transdermal System (TDS) as Compared to Placebo TDS in Patients With a Chalazion
NCT03248440
Evaluation of Effectiveness and Safety of Intense Pulsed Light Treatment for Chalazion
NCT07039461
Comparison Between Continuous and Pulsed Oral Doxycycline Treatment Protocols for Refractory Meibomian Gland Dysfunction
NCT06520007
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Observation
30 patients will be randomized to observation alone. These patients will return 4 weeks (+/- 2 weeks) after their initial visit for lesion measurement and photographs.
No interventions assigned to this group
Tetracycline
30 patients will be randomized to treatment with an intralesional injection of 0.05 mL of 2% tetracycline solution. These subjects will return 4 weeks (+/- 2 weeks) after treatment for lesion measurement and photographs.
Tetracycline
Chalazia randomized to the treatment arm will be injected with 0.05 mL of 2% tetracycline solution.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tetracycline
Chalazia randomized to the treatment arm will be injected with 0.05 mL of 2% tetracycline solution.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Not pregnant
* Chalazia of greater than 1 week duration
* Not allergic to tetracycline or its derivatives
* Not currently taking tetracycline or not taking them in the past 3 months
Exclusion Criteria
* Pregnancy
* Chalazia of less than 1 week duration
* Allergies to tetracycline or its derivatives
* Currently taking tetracyclines or have taken them in the past 3 months
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Cleveland Clinic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Julian D Perry, M.D.
Role: PRINCIPAL_INVESTIGATOR
Cleveland Clinic Cole Eye Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cleveland Clinic Cole Eye Institute
Cleveland, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ashindoitiang JA. Preliminary report of the effectiveness of tetracycline sclerotherapy in treatment of ganglion. Plast Surg Int. 2012;2012:624209. doi: 10.1155/2012/624209. Epub 2012 Mar 26.
Chaudry G, Burrows PE, Padua HM, Dillon BJ, Fishman SJ, Alomari AI. Sclerotherapy of abdominal lymphatic malformations with doxycycline. J Vasc Interv Radiol. 2011 Oct;22(10):1431-5. doi: 10.1016/j.jvir.2011.06.021. Epub 2011 Aug 6.
Kars B, Buyukbayrak EE, Karsidag AY, Pirimoglu M, Unal O, Turan C. Comparison of success rates of 'transvaginal aspiration and tetracycline sclerotherapy' versus 'only aspiration' in the management of non-neoplastic ovarian cysts. J Obstet Gynaecol Res. 2012 Jan;38(1):65-9. doi: 10.1111/j.1447-0756.2011.01627.x. Epub 2011 Aug 10.
Henry SL, Concannon MJ, Kaplan PA, Diaz-Arias AA. The inhibitory effect of minocycline on hypertrophic scarring. Plast Reconstr Surg. 2007 Jul;120(1):80-88. doi: 10.1097/01.prs.0000263325.73400.f8.
Griffin MO, Fricovsky E, Ceballos G, Villarreal F. Tetracyclines: a pleitropic family of compounds with promising therapeutic properties. Review of the literature. Am J Physiol Cell Physiol. 2010 Sep;299(3):C539-48. doi: 10.1152/ajpcell.00047.2010. Epub 2010 Jun 30.
Souchier M, Joffre C, Gregoire S, Bretillon L, Muselier A, Acar N, Beynat J, Bron A, D'Athis P, Creuzot-Garcher C. Changes in meibomian fatty acids and clinical signs in patients with meibomian gland dysfunction after minocycline treatment. Br J Ophthalmol. 2008 Jun;92(6):819-22. doi: 10.1136/bjo.2007.133900. Epub 2008 May 29.
Ben Simon GJ, Huang L, Nakra T, Schwarcz RM, McCann JD, Goldberg RA. Intralesional triamcinolone acetonide injection for primary and recurrent chalazia: is it really effective? Ophthalmology. 2005 May;112(5):913-7. doi: 10.1016/j.ophtha.2004.11.037.
Lacy CF, Armstrong LL, Goldman, MP, Lance LL. Lexi-Comp's Drug Information Handbook. 13th ed. 2005. 1447.
Wolff K, Johnson RA, et al. Fitzpatrick's Color Atlas & Synopsis of Clinical Dermatology. 5th ed. McGraw-Hill. 2005.
Macquire JI, Murchinson AP, et al. Wills Eye Institute 5-minute Ophthalmology Consult. Lippencott Williams & Wilkins.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TET2013
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.