Comparison of the effect of triamcinolone 1.0% topical cream with timolol 0.5% cream in the treatment of patients with hand and/or foot eczema.
Design
A clinical trial with a control group, parallel groups, double-blind, randomized, phase 3 on 32 patients (64 body part/samples). Sealed envelope will be used for randomization.
Settings and conduct
The study is being conducted on a group of 32 patients with eczema visiting the dermatology clinics of Alzahra and Sadegheh Tahereh hospitals. The study is a clinical trial. Triamcinolone 1% cream is used on one hand or foot, and timolol 0.5% cream is used on the opposite hand or foot in this study. After 4 weeks, patients are visited for treatment evaluation, and they are visited again for re-evaluation after another 4 weeks. Patients are scored based on the modified total lesion symptom score (mTTLSS). The type of treatment is determined by the pharmacist, and patients and doctors are not aware of the treatment type.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients presenting to the Alzahra and Sadeghieh skin clinics with complaints of hand or foot eczema.
Exclusion criteria: Pregnancy; lactation; cardiac arrhythmias; hypertension; syncope history
Intervention groups
Intervention group 1: puts triamcinolone cream on the right hand or foot and timolol cream on the left hand or foot. Intervention group 2: they put triamcinolone cream on the left hand or foot and timolol cream on the right hand or foot.
Main outcome variables
modified Total Lesion Symptom Score( mTLSS)
Score 1:mild
Score2:moderate
Score3:severe
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150706023081N3
Registration date:2024-03-04, 1402/12/14
Registration timing:prospective
Last update:2024-03-04, 1402/12/14
Update count:0
Registration date
2024-03-04, 1402/12/14
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2020
Email address
iraji@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-25, 1403/01/06
Expected recruitment end date
2026-01-24, 1404/11/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of triamcinolone 0.1% topical cream with Timolol 0.5% topical cream in the treatment of patients with hand or foot eczema
Public title
The effect of Timolol cream in the treatment of eczema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients referred to Alzahra and Sediqah Tahereh skin clinic
Presence of hand or foot eczema complication
Exclusion criteria:
Cardiac arrhythmia disorders
Hypertension
History of syncope
Pregnancy
Breastfeeding
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
32
More than 1 sample in each individual
Number of samples in each individual:
2
One group applies triamcinolone cream to the right hand or foot and timolol cream to the left hand or foot, while the other group applies triamcinolone cream to the left hand or foot and timolol cream to the right hand or foot.
Randomization (investigator's opinion)
Randomized
Randomization description
Using sealed envelope technique, patients will be randomly divided into 2 groups of 32 patients treated with triamcinolone in the right hand or foot and timolol in the left hand or foot in one group and treated with triamcinolone in the left hand or foot and timolol in the right hand or foot in the other group. There will be 32 envelopes, 16 of which will the letter "a" been written on them and the other 16 have the letter "b" written on them. For each patient who enters the study, we will randomly pick one of the envelopes and the patient will be placed in that group. The kind of treatment in group a and group b will be determined by the pharmacist so that the researcher won't be aware of the treatment for each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
One group applies triamcinolone cream to the right hand or foot and timolol cream to the left hand or foot, while the other group applies triamcinolone cream to the left hand or foot and timolol cream to the right hand or foot. The doctor and the patient are unaware of this, and it is the responsibility of the pharmacist to determine which group is group one and which group is group two.Both topical cream models have similar packaging
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan university of medical sciences
Street address
Hezarjerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-12-24, 1402/10/03
Ethics committee reference number
IR.MUI.MED.REC.1402.356
Health conditions studied
1
Description of health condition studied
eczema
ICD-10 code
L20.9
ICD-10 code description
Atopic dermatitis, unspecified
Primary outcomes
1
Description
modified Total Lesion Symptom Score( mTLSS)
Timepoint
At the beginning of the study and 4 weeks and 8 weeks after the start of treatment
Method of measurement
Taking pictures and measuring the modified Total Lesion Symptom Score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:Triamcinolone cream 0.1% is applied to the right hand or foot once a day for 4 weeks and timolol 0.5% cream is applied to the left hand or foot once a day for 4 weeks.
Category
Treatment - Drugs
2
Description
Intervention group 2:Triamcinolone cream 0.1% is applied to the left hand or foot once a day for 4 weeks and timolol 0.5% cream is applied to the right hand or foot once a day for 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Mehrdad Noroozi
Street address
Hezarjarib
City
Isfahan
Province
Isfehan
Postal code
7573181746
Phone
+98 31 3822 0000
Email
Alzahra@mui.ac.ir
2
Recruitment center
Name of recruitment center
Sadeghieh Tahereh Clinic
Full name of responsible person
Dr. Zabihollah Shahmoradi
Street address
Khorram st.
City
Isfahan
Province
Isfehan
Postal code
8187698191
Phone
+98 31 3335 9933
Email
emrc@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyyed Hussein Bani Hashemi
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Fax
+98 31 3668 0048
Email
researches@mui.ac.ir
Web page address
https://mui.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Fariba Iraji
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Hezarjarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Fax
+98 31 3668 4510
Email
iraji@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fariba Iraji
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Hezarjarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Fax
+98 31 3668 4510
Email
iraji@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fariba Iraji
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Hezarjarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Fax
+98 31 3668 4510
Email
iraji@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data and variables are published except for patients' private information.
When the data will become available and for how long
Immediately after the article is published
To whom data/document is available
Professors and faculty members
Under which criteria data/document could be used
To better understand the article
From where data/document is obtainable
By emailing the corresponder author directly
What processes are involved for a request to access data/document
After sending an email to the responsible writer and confirming the identity, it will be sent.