NCT01763437

Brief Summary

The investigators propose a study to investigate the role of tetracycline injection into chalazia versus observation alone. The investigators hypothesize tetracycline injection will result in a significant decrease in lesion size when compared to observation alone.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2014

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 8, 2013

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

Enrollment Period

1 year

First QC Date

January 5, 2013

Last Update Submit

January 10, 2017

Conditions

ChalaziaChalazion

Keywords

ChalaziaChalazionMeibomian gland dysfunctionRosaceaOcular rosacea

Outcome Measures

Primary Outcomes (1)

  • Lesion size

    The size of the lesion will be measured as well as photographed. Photographs will be reviewed by a masked chalazion photograph reviewer.

    4 weeks

Study Arms (2)

Observation

NO INTERVENTION

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.

Tetracycline

EXPERIMENTAL

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.

Drug: Tetracycline

Interventions

TetracyclineDRUG

Chalazia randomized to the treatment arm will be injected with 0.05 mL of 2% tetracycline solution.

Tetracycline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age older than 18 years
  • 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

You may not qualify if:

  • Age less than 18 years old
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Cole Eye Institute

Cleveland, Ohio, 44145, United States

Location

Related Publications (10)

  • 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.

    PMID: 22570781BACKGROUND

  • 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.

    PMID: 21821431BACKGROUND

  • 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.

    PMID: 21827579BACKGROUND

  • 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.

    PMID: 17572548BACKGROUND

  • 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.

    PMID: 20592239BACKGROUND

  • 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.

    PMID: 18511542BACKGROUND

  • 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.

    PMID: 15878075BACKGROUND

  • Lacy CF, Armstrong LL, Goldman, MP, Lance LL. Lexi-Comp's Drug Information Handbook. 13th ed. 2005. 1447.

    RESULT

  • Wolff K, Johnson RA, et al. Fitzpatrick's Color Atlas & Synopsis of Clinical Dermatology. 5th ed. McGraw-Hill. 2005.

    RESULT

  • Macquire JI, Murchinson AP, et al. Wills Eye Institute 5-minute Ophthalmology Consult. Lippencott Williams & Wilkins.

    RESULT

MeSH Terms

Conditions

ChalazionMeibomian Gland DysfunctionRosacea

Interventions

Tetracycline

Condition Hierarchy (Ancestors)

CystsNeoplasmsEyelid DiseasesEye DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Julian D Perry, M.D.

    Cleveland Clinic Cole Eye Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2013

First Posted

January 8, 2013

Study Start

March 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

January 12, 2017

Record last verified: 2017-01

Locations

US(1)