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IRCT20140212016557N12 IRCT 2023-11-27 Shiraz University of Medical Sciences Therapeutic Effect of Cyclophosphamide cream on cutaneous lymphoma (mycosis fungoides) Evaluation of the effect of topical Cyclophosphamide compared to topical mometasone in clinical improvement of skin lesions of Cutaneous T cell lymphoma (mycosis fungoides) 2023-12-06 anticipated 20 Complete https://irct.ir/trial/72747 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients are recruited by consecutive sampling in the study. Randomization is performed by random allocation software and participants are randomly allocated in the intervention or control group. Randomization of 20 participants in the software is performed by randomization blocks size 4 with random ratio of 1:1. The output of the software is a table that shows each side of participant is allocated in the intervention or control group. Using drugs on the right or left side of body is determined randomly, Blinding description: Due to the difference of drugs, the patients are aware of the type of drugs in each side. Investigator that deliver the drugs are not involved in the outcome assessment. The outcome assessor is not aware of the type of drugs in each patient. Therefore the research will be single-blinded. 3 cutaneous T cell lymphoma (mycosis fungoides). Intervention 1: Intervention group: topical use of cyclophosphemide 2% cream on the lesion of one side of the body nightly for 3 month by the patient. According to inaccessibility to prepared topical cyclophosphamide , cyclophosphamide ampule (zydus-India) dilute in cream 2% by chemist. Intervention 2: Control group: topical use of mometasone ointment( mometasone furoate 0.1 % kish-medifarm )on the lesion of one side of the body every night for 3 months by the patient. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Possibility of loss of confidentiality
public Mozhdeh Sepaskhah
Shiraz University of Medical Sciences, Zand St., Shiraz, Iran
Shiraz Iran (Islamic Republic of) 1433671348 +98 71 3212 5239 sepaskhah@sums.ac.ir Shiraz University of Medical Sciences scientific Mozhdeh Sepaskhah
Shiraz University of Medical Sciences, Zand St., Shiraz, Iran
Shiraz Iran (Islamic Republic of) 1433671348 +98 71 3212 5239 sepaskhah@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) clinically- and histologically-approved cutaneous T cell lymphoma (mycosis fungoides) patients staging of disease 1A,2A,1B patients with active patches and plaques 18 years no limit Both Allergy to drugs used in the study chemotherapy with cyclophosphemide staging of disease 2B and more pregnancy lactation C84.0 Mycosis fungoides Treatment - Drugs Treatment - Drugs Intervention group: topical use of cyclophosphemide 2% cream on the lesion of one side of the body nightly for 3 month by the patient. According to inaccessibility to prepared topical cyclophosphamide , cyclophosphamide ampule (zydus-India) dilute in cream 2% by chemist. Control group: topical use of mometasone ointment( mometasone furoate 0.1 % kish-medifarm )on the lesion of one side of the body every night for 3 months by the patient. Composite Assessment of Index Lesion Severity (CAILS). Timepoint: Before intervention, 4 and 8 and 12 weeks after starting intervention. Method of measurement: Hypo/Hyperpigmentation, erythema, scale, plaque elevation according to severity from 0 - 8 and size cm2 grading in 18 states. Patients satisfaction. Timepoint: 4 and 8 and 12 weeks after starting intervention. Method of measurement: Greatly decreased = -3 , moderately decreased = -2 , slightly decreased = -1 , no change = 0 , slightly increased = +1, moderately increased = +2 , greatly increased= +3 , Don’t know= photograph was not suitable for proper clinical evaluation. Physisian global assessment (PGA). Timepoint: Before intervention, 4 and 8 and 12 weeks after starting intervention. Method of measurement: Clear: No signs of MF, but postinflammatory discoloration may be present 1= Almost clear: Only minimal patch/plaque visible, scaling, atrophy, and erythema .2= Mild: Slight patch/plaque visible, scaling, atrophy, and erythema. 3=Moderate: Moderate patch/plaque visible, scaling, atrophy, and erythema.4=Severe: Very marked patch/plaque visible, scaling, atrophy, and erythema. Shiraz University of Medical Sciences Approved 2023-10-09 Ethics committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences, Zand St., Shiraz. Iran Shiraz Fars Iran (Islamic Republic of)