Antimicrobial Resistance Clinical Trial
— ORBSOfficial title:
ORBS: Ocular Rosacea Biome Study
Ocular rosacea is an inflammatory disease of the eyelids and ocular surface. Like the facial disease, the ocular condition is chronic and recurrent. Sequelae of ocular rosacea vary from mild to severe. Ocular rosacea may cause chronic eye redness, blepharitis, recurrent chalazia, dry eye, corneal erosion, corneal vascularization, and corneal ulceration. Rosacea affecting the cornea can result in vision loss. Prescription eye drops and ointments can be used topically to control mild ocular rosacea. However, severe disease, or rosacea that is not well controlled with local treatments is treated systemically. The most commonly used systemic treatment for rosacea is the bacteriostatic antibiotic doxycycline. Rosacea treatment doses of doxycycline vary widely. Treatment-dose doxycycline for systemic infections is 100mg twice a day. However, as rosacea is considered an inflammatory disease, doxycycline is often dosed at what is termed, sub-microbial dose doxycycline (SDD). Initially introduced in the oral medicine literature, SDD are doses 40mg and lower because systemic administration at this dose does not appear to alter the oral mucosa flora or increase resistance rates when given long-term for periodontal disease. Whereas 100mg doxycycline, even when given short term, may increase the percentage of culturable nasopharyngeal flora that is resistant to doxycycline. The FDA does not categorize SDD an antibiotic, stating this dosing is expected to exhibit only anti-inflammatory activity.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2025 |
Est. primary completion date | October 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Have symptomatic ocular disease attributed to ocular rosacea as the primary diagnosis - Ability to give informed consent - Be aged 18 years old or older Exclusion Criteria: - Have an active ocular or systemic infection - Have a known allergy or intolerance to tetracycline antibiotics - Have had prior use of oral antibiotics within the last three months - Pregnancy or the possibility of becoming pregnant within the 8-week study medication timeline. |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Farncisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Anon. Periostat [package insert]. Place of publication: Galderma; 2001
Del Rosso JQ, Brantman S, Baldwin H. Long-term inflammatory rosacea management with subantibiotic dose oral doxycycline 40 mg modified-release capsules once daily. Dermatol Ther. 2022 Jan;35(1):e15180. doi: 10.1111/dth.15180. Epub 2021 Dec 2. — View Citation
Del Rosso JQ, Schlessinger J, Werschler P. Comparison of anti-inflammatory dose doxycycline versus doxycycline 100 mg in the treatment of rosacea. J Drugs Dermatol. 2008 Jun;7(6):573-6. No abstract available. — View Citation
Nagler AR, Del Rosso J. The Use of Oral Antibiotics in the Management of Rosacea. J Drugs Dermatol. 2019 Jun 1;18(6):506. — View Citation
Preshaw PM, Novak MJ, Mellonig J, Magnusson I, Polson A, Giannobile WV, Rowland RW, Thomas J, Walker C, Dawson DR, Sharkey D, Bradshaw MH. Modified-release subantimicrobial dose doxycycline enhances scaling and root planing in subjects with periodontal disease. J Periodontol. 2008 Mar;79(3):440-52. doi: 10.1902/jop.2008.070375. — View Citation
Schaller M, Almeida LM, Bewley A, Cribier B, Dlova NC, Kautz G, Mannis M, Oon HH, Rajagopalan M, Steinhoff M, Thiboutot D, Troielli P, Webster G, Wu Y, van Zuuren E, Tan J. Rosacea treatment update: recommendations from the global ROSacea COnsensus (ROSCO) panel. Br J Dermatol. 2017 Feb;176(2):465-471. doi: 10.1111/bjd.15173. Epub 2017 Feb 5. — View Citation
Schaller M, Kemeny L, Havlickova B, Jackson JM, Ambroziak M, Lynde C, Gooderham M, Remenyik E, Del Rosso J, Weglowska J, Chavda R, Kerrouche N, Dirschka T, Johnson S. A randomized phase 3b/4 study to evaluate concomitant use of topical ivermectin 1% cream and doxycycline 40-mg modified-release capsules, versus topical ivermectin 1% cream and placebo in the treatment of severe rosacea. J Am Acad Dermatol. 2020 Feb;82(2):336-343. doi: 10.1016/j.jaad.2019.05.063. Epub 2019 May 29. Erratum In: J Am Acad Dermatol. 2021 May;84(5):1506. — View Citation
Skidmore R, Kovach R, Walker C, Thomas J, Bradshaw M, Leyden J, Powala C, Ashley R. Effects of subantimicrobial-dose doxycycline in the treatment of moderate acne. Arch Dermatol. 2003 Apr;139(4):459-64. doi: 10.1001/archderm.139.4.459. — View Citation
Woo YR, Lee SH, Cho SH, Lee JD, Kim HS. Characterization and Analysis of the Skin Microbiota in Rosacea: Impact of Systemic Antibiotics. J Clin Med. 2020 Jan 9;9(1):185. doi: 10.3390/jcm9010185. — View Citation
Zhang M, Silverberg JI, Kaffenberger BH. Prescription patterns and costs of acne/rosacea medications in Medicare patients vary by prescriber specialty. J Am Acad Dermatol. 2017 Sep;77(3):448-455.e2. doi: 10.1016/j.jaad.2017.04.1127. Epub 2017 Jun 23. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of Antimicrobial Resistance (AMR) genetic determinants | The frequency of AMR genetic determinants in rectal swab samples between arms will be compared, correcting for baseline | 8 weeks | |
Secondary | Differences in Simpson's diversity of the microbiome of the conjunctiva and gut | Simpson's diversity is the probability that any two randomly chosen reads will be for different organisms (at the genus level). This will be expressed in terms of effective number. | 4 weeks , 8 weeks, 3 - 6 months | |
Secondary | Ocular Surface Disease Index (OSDI) will be compared | Scores range from 0 to 100, with higher scores indicating greater symptom severity.
Standard 12-question created by the Outcomes Research Group at Allergan Inc will be used. |
4 weeks , 8 weeks, 3 - 6 months | |
Secondary | Tear Breakup Time (TBUT) scores will be compared | Numbers representing how many seconds after a full blink a discontinuity in the tear film appears.
Obtained with the Oculus keratography topographer This is a scale typically measured from 1-10, and the seconds correspond to the amount of time it takes for a tear film discontinuity to be observed. The lower the number the faster the tear break up and the worse the objective dry eye. |
4 weeks , 8 weeks, 3 - 6 months |
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