Therapeutic Effect of Cyclophosphamide cream on cutaneous lymphoma (mycosis fungoides)

Phase 3

Recruiting

• Conditions: cutaneous T cell lymphoma (mycosis fungoides).; Mycosis fungoides; C84.0

• Registration Number: IRCT20140212016557N12
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

clinically- and histologically-approved cutaneous T cell lymphoma (mycosis fungoides) patients
staging of disease 1A,2A,1B
patients with active patches and plaques

Exclusion Criteria

Allergy to drugs used in the study
chemotherapy with cyclophosphemide
staging of disease 2B and more
pregnancy
lactation

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.