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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TERMINATED
PHASE4
54 participants
INTERVENTIONAL
2000-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
8-MOP + UVA x 24 weeks
PUVA (8-MOP + UVA)
Weeks 1-24: 8.MOP: 0.6 MG/K, 3 times a week, 2 hours pre UVA irradiation (1-2 jul/cm2 according to phototype, increasing until 10 Jul/cm2, if tolerated)
B
IFN alone, 2 weeks, 8-MOP + UVA irradiation + IFN, 22 weeks
PUVA (8MOP + UVA) + IFN
Weeks 3-24: 8.MOP: 0.6 MG/K, 3 times a week, 2 hours pre UVA irradiation (1-2 jul/cm2 according to phototype, increasing until 10 Jul/cm2, if tolerated) IFN: week1: 3, 6 and 9 MU (Mon, Wed, Fry). Weeks 2-24: 9MU 3 times a week)
Interventions
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PUVA (8MOP + UVA) + IFN
Weeks 3-24: 8.MOP: 0.6 MG/K, 3 times a week, 2 hours pre UVA irradiation (1-2 jul/cm2 according to phototype, increasing until 10 Jul/cm2, if tolerated) IFN: week1: 3, 6 and 9 MU (Mon, Wed, Fry). Weeks 2-24: 9MU 3 times a week)
PUVA (8-MOP + UVA)
Weeks 1-24: 8.MOP: 0.6 MG/K, 3 times a week, 2 hours pre UVA irradiation (1-2 jul/cm2 according to phototype, increasing until 10 Jul/cm2, if tolerated)
Eligibility Criteria
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Inclusion Criteria
* Written informed consent
* 18-70 y.o., both sex
* No concomitant systemic disease
Exclusion Criteria
* Fertile women not accepting contraception
* Medical history of melanoma or non melanoma skin cancer
* Concomitant infections
* Immunodeficiency states
* Previous Heart disease
* Respiratory insufficiency
* Chronic RRenal insufficiency
* Chronic hepatopathy
* Epilepsy
* Depression
* Leucocytes \<3000 or neutrophiles \<1000 or thrombocytes \<100000 or hemoglobin \<12 gr/dL or ANA \<1/80
* Treatment with systemic steroids
* Altered thyroid hormones
* Previous resistance to PUVA and/or IFN
* Hypersensitivity to IFN
* Patients under treatment with teophiline and/or dicumarol
* Previous total skin electron beam
* Wash up period less than 3 month for IFN and /or PUVA
* Wash up period less than 1 month for topical treatments
18 Years
70 Years
ALL
No
Sponsors
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Madrilenian Group of Cutaneous Lymphomas
OTHER
Responsible Party
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Servicio de Dermatología. Hospital 12 de Octubre
Principal Investigators
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Francisco Vanaclocha Sebastián, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital 12 de Octubre
Jesús Fernández Herrera, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Locations
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Hospital Príncipe de Asturias.
Alcalá de Henares, Madrid, Spain
Hospital Universitario de Getafe
Getafe, Madrid, Spain
Hospital de la Princess
Madrid, Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
Fundación Jiménez Díaz
Madrid, Madrid, Spain
Hospital Clínico San Carlos
Madrid, Madrid, Spain
Hospital Gómez Ulla
Madrid, Madrid, Spain
Hospital La Paz
Madrid, Madrid, Spain
Hospital Ramón y Cajal
Madrid, Madrid, Spain
Countries
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References
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Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.
Other Identifiers
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MF99
Identifier Type: -
Identifier Source: org_study_id
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