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Comparison of the effect of Triamcinolone 0.1% topical cream with sulfur 2% cream in the treatment of patients with hand eczema

Protocol summary

Study aim
Comparison of the average score of itching, burning, dryness and erythema of the hand before, 4 weeks after treatment and 4 weeks after follow-up in two groups
Design
Clinical trial with 2 comparative intervention groups without control group, with parallel groups, triple blind, randomized, phase 3 on 70 patients. For randomization, the patient chooses to use each cream for one hand.
Settings and conduct
The target population is all patients who refer to the skin clinic of Al-Zahra and Sedige Tahereh Hospital in Isfahan city with the complaint of hand eczema. In this study, there are ready-to-use creams in the market, which in order to create a three-way blinding of the study, under sterile conditions, the creams are poured into tubes without a printed brand, and the cream is named by the company as numbers 1 and 2, and until At the time of completion of the study, the patient and the project manager and the data analyst do not know the type of cream received, so that the study is triple-blinded.
Participants/Inclusion and exclusion criteria
Entry condition 1- All patients with hand eczema 2- Patients who have not been treated in the last month. Non-entry condition 1- There are patients who are taking another medicine 2-Patients who do not have the possibility to refer for the necessary follow-up 3-Patients who are accompanied by other skin diseases in the hand area other than eczema
Intervention groups
Each participant receives 2 creams. One of the creams contains Triamcinolone and the other cream contains sulfur, which the patient chooses to use one cream for the right hand and one cream for the left hand.
Main outcome variables
itching; burning; dryness; Erythema

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220306054206N2
Registration date: 2022-12-26, 1401/10/05
Registration timing: registered_while_recruiting

Last update: 2022-12-26, 1401/10/05
Update count: 0
Registration date
2022-12-26, 1401/10/05
Registrant information
Name
Parisa Mohamadian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3444 8056
Email address
parisa.m@edu.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2023-03-20, 1401/12/29
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 sulfur 2% cream in the treatment of patients with hand eczema
Public title
Comparison of the effect of Triamcinolone topical cream with sulfur cream in hand eczema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who have hand eczema and patients have not been treated in the last month.
Exclusion criteria:
There are patients who are taking another medicine Patients who do not have the possibility to refer for the necessary follow-up Patients who have other accompanying skin disease in the hand area other than eczema
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 70
More than 1 sample in each individual
Number of samples in each individual: 2
Each participant uses one cream for the right hand and another cream for the left hand
Randomization (investigator's opinion)
Randomized
Randomization description
Since each patient uses two types of creams, and since the patient's right-handedness or left-handedness may affect the severity of each hand's eczema, it is up to the patient to choose the type of cream to use for each hand. so that randomization is done in this way and the intervention of the executive is removed from this process.
Blinding (investigator's opinion)
Triple blinded
Blinding description
To create triple blinding of the study, under sterile conditions, creams are poured into tubes without a printed brand, and the cream is named by the company as numbers 1 and 2, and until the completion of the study, the patient and the project manager and the data analyst are of the type The received cream is not aware so that the study is triple blinded
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences and Health Services
City
isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2022-11-14, 1401/08/23
Ethics committee reference number
IR.ARI.MUI.REC.1401.223

Health conditions studied

1

Description of health condition studied
eczema
ICD-10 code
L20.82
ICD-10 code description
Flexural eczema

Primary outcomes

1

Description
Itching score
Timepoint
4 weeks after treatment and 4 weeks after follow-up
Method of measurement
Itching is given a score from 1 to 10, and for each individual cream before treatment, after 4 weeks of treatment, and after 4 weeks of follow-up, patients' itching is scored in order to check the therapeutic effect of the drugs used.

2

Description
Dryness score
Timepoint
4 weeks after treatment and 4 weeks after follow-up
Method of measurement
Dryness is given a score from 1 to 10, and for each individual cream before treatment, after 4 weeks of treatment and after 4 weeks of follow-up, patients' dryness is scored in order to check the therapeutic effect of the drugs used.

3

Description
Burning score
Timepoint
4 weeks after treatment and 4 weeks after follow-up
Method of measurement
Burning is given a score from 1 to 10, and for each individual cream before treatment, after 4 weeks of treatment and after 4 weeks of follow-up, patients' burning is scored to check the therapeutic effect of the drugs used.

4

Description
Erythema score
Timepoint
4 weeks after treatment and 4 weeks after follow-up
Method of measurement
Erythema is given a score from 1 to 10, and for each individual cream before treatment, after 4 weeks of treatment and after 4 weeks of follow-up, patients' erythema is scored to check the therapeutic effect of the drugs used.

5

Description
Satisfaction with treatment
Timepoint
4 weeks after treatment and 4 weeks after follow-up
Method of measurement
To evaluate patients' satisfaction with treatment, Vas Score is recorded

6

Description
Eczema severity
Timepoint
Before the start of treatment, the end of 4 weeks of treatment and the end of 4 weeks of follow-up
Method of measurement
Hand eczema severity index (HECSI) score is used for patients.

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group uses triamcinolone cream 0.01% from Iran Daru factory twice a day for one month on the hands, and then the use is stopped and follow-up is carried out for the next month.
Category
Treatment - Drugs

2

Description
The second intervention group uses 2% sulfur cream made by A2Z company locally 2 times a day in the hands and then stops using the cream and is followed up for the next month.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dermatology Clinic of Al-Zahra and Sedige Tahereh Hospital, Isfahan
Full name of responsible person
Parisa Mohammadian
Street address
Hazar Jarib St., University of Medical Sciences and Health Care Services
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
parisa14m@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Asgari
Street address
Hazar Jarib St., University of Medical Sciences and Health Care Services
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
parisa14m@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Parisa Mohammadian
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Education
Street address
Hazar Jarib St., University of Medical Sciences and Health Care Services
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
parisa14m@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Asilian
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Education
Street address
Hazar Jarib St., University of Medical Sciences and Health Care Services
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
asilian@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parisa Mohammadian
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Education
Street address
Hazar Jarib St., University of Medical Sciences and Health Care Services
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
parisa14m@yahoo.com

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 is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the publication of the results
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
If they have documentation of conducting research in this field, the documentation will be provided
From where data/document is obtainable
To receive the data/document from the email address of the main author
What processes are involved for a request to access data/document
Documents will be provided within a maximum of one month from the time of sending the requester's email
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