A comparison between the therapeutic effect of sertaconazole and hydrocortisone cream on mild-to-moderate atopic dermatitis
Design
The study consists of two groups of parallel and double-blind. Both the clinical researcher and patient were blind to the study. The study samples (76 patients) received drugs A and B in the order of their visit.
Settings and conduct
Children younger than 5 years and with atopic dermatitis are visited in Yasuj’s Imam Sajjad Pediatric Clinic. After determining the severity of their disease, WRT, and the type of clinical presentation, the patients with severe involvement are excluded. For the patients with mild-to-moderate skin involvement, the medication is prescribed as types A and B. Medicine efficiency is examined on days 14 and 30 after starting the medication by a physician. Next, with some indicators from previous studies and current valid references, improvement percentages are determined and the two medicines are compared. The clinical researcher and patient are blind to drug type and packaging.
Participants/Inclusion and exclusion criteria
The population of this study consists of children younger than 5 years with atopic dermatitis referred to Yasuj’s Imam Sajjad Pediatric Clinic with mild to moderate involvement. The participated in the study after granting their parent’s approval. Also, those with severe skin involvement or without parental consent were excluded.
Intervention groups
The intervention group (patients with mild and severe atopic dermatitis) received sertaconazole cream in this intervention. The control group (patients with mild and moderate atopic dermatitis) received hydrocortisone cream in this intervention.
Main outcome variables
primary outcome :skin redness relief measured by examination;secondary outcome 1: skin pruritus relief measured by a questionnaire;secondary outcome 2: skin dryness relief measured by examination.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190624043996N1
Registration date:2020-01-13, 1398/10/23
Registration timing:retrospective
Last update:2020-01-13, 1398/10/23
Update count:0
Registration date
2020-01-13, 1398/10/23
Registrant information
Name
Fatemeh Jokar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3721 0042
Email address
jokarfatemeh66@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-01, 1398/03/11
Expected recruitment end date
2019-09-17, 1398/06/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the therapeutic effect of sertaconazole cream with Hydrocortisone ointment on atopic dermatitis in children under five years
Public title
The effect of the sertaconazole cream with ointment Hydrocortisone in atopic dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children under five years with atopic medium or mild dermatitis
Exclusion criteria:
The lack of parental consent
Atopic dermatitis with sever involvement of the skin
Age
To 5 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
- The patients were initially briefed on the method and type of medication and safety of both medicines; however, it was just drugstore that knew the type of medicine in packages A and B, while the physician and patients were unaware of it. Indeed, the patient and doctor were blind to the drug type.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee university of Medical Sciences, Yasuj
Street address
Street Saheli, The hospital and clinic of Imam Sajjad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7541994579
Approval date
2019-06-01, 1398/03/11
Ethics committee reference number
IR.YUMS.REC.1398.029
Health conditions studied
1
Description of health condition studied
Atopic dermatitis
ICD-10 code
L20
ICD-10 code description
Atopic dermatitis
Primary outcomes
1
Description
Medication type
Timepoint
The primary visit is at the beginning of the study before initiating the therapy. The second, third, and fourth visits were made two weeks, one month, and six months after the start of the treatment, respectively.
Method of measurement
Measuring variables involved three visits and patient examination by clinical research at a specified time, as well as completing a questionnaire and table relating to the symptoms. The questionnaire and table of symptoms were derived from previous valid articles and scientific references.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 1: 2% sertaconazole cream, topical antifungal at a dose of the size of the skin involved two times a day for two weeks, topical application on the skin by hand, Farer International SA Manufactory available at Yasuj’s drug stores
Category
Treatment - Drugs
2
Description
Intervention 2: 1% hydrocortisone ointment, low effect topical corticosteroids at a dose of the size of the skin coverage of the affected area two times a day for two weeks, topical application on the skin by hand, Behvarzan Manufactory, Rash, Iran.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam sajjad hospital and clinic
Full name of responsible person
Fazel Ali
Street address
Emamat bulvar
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591836957
Phone
+98 74 3334 5868
Fax
+98 74 3322 8982
Email
Ali.fazel@yums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Ali Fazel
Street address
Emamat bulvar
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591836957
Phone
+98 74 3334 5868
Fax
Email
Ali.fazel@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Fazel Ali
Position
Associated Professor
Latest degree
Subspecialist
Other areas of specialty/work
Allergist and clinical immunology
Street address
Emamat bulvr
City
Yassuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591836957
Phone
+98 74 3334 5868
Fax
Email
Ali.fazel@yums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Fazel Ali
Position
Associated Professor
Latest degree
Subspecialist
Other areas of specialty/work
Allergist and clinical immunology
Street address
Emamat bulvar
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591836957
Phone
+98 74 3334 5868
Email
Ali.fazel@yums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Jokar Fatemeh
Position
Assistant specialized children
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Saheli Street, Imam Sajad Hospital
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7541994579
Phone
+98 74 3322 0164
Email
jokarfatemeh66@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