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Evaluation of the effect of topical Cyclophosphamide compared to topical mometasone in clinical improvement of skin lesions of Cutaneous T cell lymphoma (mycosis fungoides)

Protocol summary

Study aim
Evaluation of the therapeutic effect of topical cyclophosphamide on cutaneous T cell lymphoma (mycosis fungoides)
Design
Phase 3, pilot, parallel group, split body trial, clinical trial, with consecutive sampling, including 20 patients, single blinded, computerized randomized with permuted blocks
Settings and conduct
The study is conducted in the dermatology clinic of Shiraz University of Medical Sciences.The patients use topical cyclophosphamide on a lesion every night and mometasone ointment on a similar lesion at other site of body. The patients are visited by a blinded investigator before intervention, 4, 8 and 12 weeks after starting intervention and are evaluated for Composite Assessment of Index Lesion Severity (CAILS). 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.
Participants/Inclusion and exclusion criteria
Inclusion criteria:18 years old and more patients with clinically- and histopathologically-approved cutaneous T-cell lymphoma (mycosis fungoides) in stages 1A ,1B, 2A and active patches and plaques Exclusion criteria: Allergy to drugs used in the study, chemotherapy with cyclophosphemide, staging of disease 2B and more, pregnancy, lactation
Intervention groups
Intervention group: Patients use cyclophosphamide cream on a lesion every night. Control group: Patients use mometasone ointment on similar lesion on other site of body.
Main outcome variables
Composite Assessment of Index Lesion Severity (CAILS)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140212016557N12
Registration date: 2023-11-27, 1402/09/06
Registration timing: prospective

Last update: 2023-11-27, 1402/09/06
Update count: 0
Registration date
2023-11-27, 1402/09/06
Registrant information
Name
Mozhdeh Sepaskhah
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 712125239
Email address
sepaskhah@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-06, 1402/09/15
Expected recruitment end date
2024-09-24, 1403/07/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of topical Cyclophosphamide compared to topical mometasone in clinical improvement of skin lesions of Cutaneous T cell lymphoma (mycosis fungoides)
Public title
Therapeutic Effect of Cyclophosphamide cream on cutaneous lymphoma (mycosis fungoides)
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 20
More than 1 sample in each individual
Number of samples in each individual: 2
Study designed to a lesion on the right side and one in the left side is treated randomly by one of the drugs using block randomization.
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand St., Shiraz. Iran
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2023-10-09, 1402/07/17
Ethics committee reference number
IR.SUMS.MED.REC.1402.272

Health conditions studied

1

Description of health condition studied
cutaneous T cell lymphoma (mycosis fungoides)
ICD-10 code
C84.0
ICD-10 code description
Mycosis fungoides

Primary outcomes

1

Description
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 outcomes

1

Description
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

2

Description
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

Intervention groups

1

Description
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.
Category
Treatment - Drugs

2

Description
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.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dermatology clinic, Shahid Faghihi hospital
Full name of responsible person
Mozhdeh Sepaskhah
Street address
Dermatology clinic, Faghihi hospital, Zand St.
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3212 5239
Email
sepaskhah@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hashem Hashempour
Street address
Research Council, Shiraz University of Medical Sciences, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Research grant of the Research Council of Shiraz University of Medical Sciences
Grant code / Reference number
28279
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mozhdeh Sepaskhah
Position
Associate prefessor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Shiraz University of Medical Sciences, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
1433671348
Phone
+98 71 3212 5239
Fax
+98 71 3231 9049
Email
sepaskhah@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mozhdeh Sepaskhah
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Shiraz University of Medical Sciences, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
1433671348
Phone
+98 71 3212 5239
Fax
+98 71 3231 9049
Email
sepaskhah@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mozhdeh Sepaskhah
Position
Associate professore
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Shiraz University of Medical Sciences, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
1433671348
Phone
+98 71 3212 5239
Fax
+98 71 3231 9049
Email
sepaskhah@sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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