Topical Interferon Alfa 2b and Mitomycin C in Conjunctival-Corneal Intraepithelial Neoplasia
NCT ID: NCT02199327
Last Updated: 2017-08-08
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
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COMPLETED
PHASE4
18 participants
INTERVENTIONAL
2014-05-31
2017-07-31
Brief Summary
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Detailed Description
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Controlled clinical trial , single-blind , randomized . Non-probability sampling of consecutive cases. Patients will be assigned to treatment with MMC or INFα2b Periodic clinical evaluations and photos will be made. Time of resolution, resistance and adverse effects will be determined.
Patients treated with mitomycin will be handled by cycles until resolution of the lesion, which according to previous studies is expected between 3 and 6 cycles (between half months and 3 months).
Patients managed with interferon will be treated for a period ranging from one month to 12 months according to clinical resolution of the lesion. Both groups will be evaluated by at least one year after the resolution of the lesion to determine the presence of recurrences.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Mitomycin C
Mitomycin C 0.04% 4 times daily for 7 days and 7 days off until resolution of neoplasia (3-6 cycles).
Mitomycin C
Patients treated with mitomycin will be handled by cycles until resolution of the lesion, which according to previous studies is expected between 3 and 6 cycles (between half months and 3 months).
Interferon alfa 2b
Interferon alfa-2b 1 million IU/ml 4 times daily until complete resolution of the tumor
Interferon Alfa-2b
Patients managed with interferon will be treated for a period ranging from one month to 12 months according to clinical resolution of the lesion. Both groups will be evaluated by at least one year after the resolution of the lesion to determine the presence of recurrences
Interventions
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Mitomycin C
Patients treated with mitomycin will be handled by cycles until resolution of the lesion, which according to previous studies is expected between 3 and 6 cycles (between half months and 3 months).
Interferon Alfa-2b
Patients managed with interferon will be treated for a period ranging from one month to 12 months according to clinical resolution of the lesion. Both groups will be evaluated by at least one year after the resolution of the lesion to determine the presence of recurrences
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with corneal abrasion
* Patients who have the diagnosis of CIN, but are pregnant
18 Years
90 Years
ALL
No
Sponsors
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Instituto Mexicano del Seguro Social
OTHER_GOV
University of Guadalajara
OTHER
Coordinación de Investigación en Salud, Mexico
OTHER_GOV
Responsible Party
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Principal Investigators
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Alvarado Beatriz, M.D.
Role: PRINCIPAL_INVESTIGATOR
Instituto Mexicano del Seguro Social
Locations
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IMSS Centro Médico de Occidente
Guadalajara, Jalisco, Mexico
Countries
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Other Identifiers
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R-2012-785-094
Identifier Type: -
Identifier Source: org_study_id
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