Investigating the effect of Olopatadine 0.2% cream compared to Fluocinolone 0.025 % cream in the treatment of hand eczema in patients referred to the skin clinic of imam Khomeini Hospital, Ahvaz
Design
The clinical trial has 2 groups with randomized double-blind parallel groups, phase 2 on 76 patient ,random numbers table was used for randomization
Settings and conduct
This study will be conducted in the field of hand eczema treatment of patients referred to the skin clinic of Imam Hospital .In this way ,the people eligible to enter the study will be randomly divided into two groups and one group will be given olopatadine cream .Both of them are unaware of the contents of each of the creams, the method of use is fully explained to the patient ,and by using the HESCI score for the clinical symptoms of eczema and the NRS score for the itch of the patient ,the rate of improvement of the patient's symptoms every two weeks and at the end it is evaluated after one month from the end of the treatment
Participants/Inclusion and exclusion criteria
All patients over 18 years old whose hand eczema is confirmed by biopsy or dermatologist diagnosis has been
Intervention groups
In this study, patients with hand eczema were divided into two groups, one group was treated with olopatadine cream and the other group was treated with fluocinolone cream. Both creams are in the form of 1 gram twice a day
Main outcome variables
Reducing the use of topical corticosteroids due to its many side effects in long-term use, restoring skin barrier function by topical antihistamines (in this study, olopatadine cream) reducing the need for oral antihistamines
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240614062122N1
Registration date:2024-06-29, 1403/04/09
Registration timing:prospective
Last update:2024-06-29, 1403/04/09
Update count:0
Registration date
2024-06-29, 1403/04/09
Registrant information
Name
Zahra Joriz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 3609
Email address
mina.joriz@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-06, 1403/04/16
Expected recruitment end date
2024-10-07, 1403/07/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of Olopatadine %0.2 cream with Fluocinolone %0.025 cream in the treatment of hand eczema in patients
Public title
Effect of Olopatadine in treatment of hand eczema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with a diagnosis of hand eczema ,(including all types of eczema in the acute phase )whose disease is confirmed by biopsy or a dermatologist's diagnosis
The age of the patients is 18 years or older
Consent to participate in the study
Exclusion criteria:
Pregnant and breastfeeding
Systemic treatment has been done in the last 3 months or local treatment 2 weeks ago
The place of use of the medicine is infectious
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the allocation of patients to each of the treatment groups will be done by random method (the patients are divided into two groups A and B using the coin toss method and then using the table random numbers are assigned to each group
Blinding (investigator's opinion)
Double blinded
Blinding description
Both categories of drugs are in tubs with the same shape,indistinguishable for the patient and the researcher,and with the numbering that will be written on them by the Faculty of Pharmacy when both drugs are tubed.It will be provided to the patient and the researcher also has the role of clinical caregiver and outcome assessor and date analyst,so the researcher and the patient are kept blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jondishapur University of Medical Sciences
Street address
No.143,Taef Apartment, West Dez Street ,Amaniyeh
City
Ahvaz
Province
Khouzestan
Postal code
6133864473
Approval date
2024-06-05, 1403/03/16
Ethics committee reference number
IR.AJUMS.REC.1403.111
Health conditions studied
1
Description of health condition studied
Investigating the effect of Olopatadine cream on hand eczema
ICD-10 code
L20.8
ICD-10 code description
Other atopic dermatitis
Primary outcomes
1
Description
The severity score of the clinical symptoms of hand eczema using the Hand Eczema Severity Index ,as well as the evaluation of the severity of itching using the Neurologic Rating Scale
Timepoint
Measuring the intensity of the clinical symptoms of hand eczema using the Hand Eczema Severity Index and itching intensity using the Neurologic Rating Scale at the beginning of the study ,then every two weeks until the end of the study (for 3 months) and 4 weeks after the end of the study
Method of measurement
Hand Eczema Severity Index Neurologic Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 38 patients with hand eczema was treated with 0.2% Olopatadine cream ,and each patient applied 1 gram or one centimeter of the cream on the finger twice a day and rotated it on massage the eczema lesion. Olopatadine drug ,which was originally available in power form, was formulated by the Faculty of Pharmacy of Jundishapur University of Ahvaz in accordance with the American Pharmacopoeia and the principles of pharmaceutics and will be provided to the patient as a 0.2% cream in multi-layer laminated tubes with a label attached.
Category
Treatment - Drugs
2
Description
Intervention group: 38 patients with hand eczema was treated with Fluocinolone 0.025% cream ,and each patient applied 1 gram or one centimeter of the cream on the finger twice a day and rotated it on massage the eczema lesion. Fluocinolone cream is produced by Tehran Chemie Pharmaceutical Company ,and it is provided to the patients as a cream in multi-layer laminated tube similar to the cover of Olopatadine
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Clinic of Imam Khomeini Hospital,Ahvaz
Full name of responsible person
Pazyar Nader
Street address
No.143,Taef Apartment, West Dez Street ,Amaniyeh
City
Ahvaz
Province
Khouzestan
Postal code
6133864473
Phone
+98 61 3333 3609
Email
Dr.pazyar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Pazyar Nader
Street address
No.143,Taef Apartment, West Dez Street ,Amaniyeh
City
Ahvaz
Province
Khouzestan
Postal code
6133864473
Phone
+98 61 3333 3609
Email
Dr.pazyar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Pazyar Nader
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No.143,Taef Apartment, West Dez Street ,Amaniyeh
City
Ahvaz
Province
Khouzestan
Postal code
6133864473
Phone
+98 61 3333 3609
Email
Dr.pazyar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Pazyar Nader
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No.143,Taef Apartment, West Dez Street ,Amaniyeh
City
Ahvaz
Province
Khouzestan
Postal code
6133864473
Phone
+98 61 3333 3609
Email
Dr.pazyar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Pazyar Nader
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No.143,Taef Apartment, West Dez Street ,Amaniyeh
City
Ahvaz
Province
Khouzestan
Postal code
6133864473
Phone
+98 61 3333 3609
Email
Dr.pazyar@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available