Comparison of the efficacy of combined therapy with topical azathioprine and betamethasone emollient cream versus monotherapy with topical betamethasone emollient cream in 2-18 year-old patients with moderate to severe atopic dermatitis.
Objectives:To compare the efficacy of topical azathioprine-betamethasone emolient cream with betamethasone emolient cream for moderate to severe cutaneous lesions of atopic dermatitis.
Design: Randomized, single-blind, clinical trial.
Setting and Conduct:70 Patients whose clinical SCORAD index is greater than 25 ,divide in two groups and receive topical azathioprine- betamethasone cream(case group) and betamethasone cream (control group). Outcome measures will be assessed at baseline,8th week and one month after the completion of the treatment. In addition, the patients will be examined for any potential adverse effects at the end of the first week of the treatment course. Finally the rate of variation in SCORAD index before and after treatment will be evaluated.
Major Inclusion and Exclusion criteria: Inclusion criteria: patients in the range of 2-18 years old; patients with no enough response to conventional topical therapies in recent past 6 months; patients who do not receive any systemic drug which interacts with azathioprine in recent past 1 month; patients with out any liver and bone marrow dysfunction. Exclusion criteria: any labratory abnormality.
Intervention: Patients receive topical treatment twice daily for 8 weeks for cutaneous lesions of the total body other than face ( case group : azathioprine-betamethasone, control group : betamethasone ).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014092519292N1
Registration date:2014-11-14, 1393/08/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-11-14, 1393/08/23
Registrant information
Name
Sadaf Farhadi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3785 0842
Email address
sadaffarhadi@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research of Isfahan University of Medical Sciences.
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of combined therapy with topical azathioprine and betamethasone emollient cream versus monotherapy with topical betamethasone emollient cream in 2-18 year-old patients with moderate to severe atopic dermatitis.
Public title
Efficacy of topical azathioprine-betamethasone cream with betamethasone cream in cutaneous eczema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children older than 2 years; patients with no enough response to conventional topical therapies in recent past 6 months; patients who do not receive any systemic drug which interacts with azathioprine in recent past 1 month; patients whose lesions are not limited to the face; patients with out any liver and bone marrow dysfunction.
Exclusion criteria: any labratory abnormality; patients who do not desired to stay in the study.
Age
From 2 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Deputy of research of Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan.
City
Isfahan
Postal code
Approval date
2014-09-07, 1393/06/16
Ethics committee reference number
393464
Health conditions studied
1
Description of health condition studied
Atopic dermatitis
ICD-10 code
L20.9
ICD-10 code description
Atopic dermatitis
Primary outcomes
1
Description
Clinical severity of cutaneous lesions
Timepoint
At baseline, at the end of the treatment course(8th week), one month after the cessation of the treatment.
Method of measurement
SCORAD index
Secondary outcomes
1
Description
Recurrence of cutaneous lesions
Timepoint
1 month after the cessation of the treatment
Method of measurement
Physical exam and history taking
Intervention groups
1
Description
Patients in intervention group should use the azathioprine-betamethasone emolient cream twice daily for 8 weeks on cutaneous lesions of the whole body except for face.
Category
Treatment - Drugs
2
Description
Patients in control group should use betamethasone emolient cream twice daily for 8 weeks on all cutaneous lesions of the body except for face.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of dermatology of Al Zahra Hospital
Full name of responsible person
Dr Sadaf Farhadi
Street address
Hezar jerib Avenue, Isfahan
City
Isfahan
2
Recruitment center
Name of recruitment center
Noor and Aliasghar Hospital
Full name of responsible person
Dr Sadaf Farhadi
Street address
Hasht behesht Street, Isfahan.
City
Isfahan
3
Recruitment center
Name of recruitment center
Skin disease and Leishmaniasis Research Center
Full name of responsible person
Dr Sadaf Farhadi
Street address
Khorram Street, Johouri Square, Isfahan.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Isfahan University of Medical Sciences
Full name of responsible person
Dr Ebrahim Esfandiari
Street address
Deputy of Research of Isfahan University of Medical Sciences, Hezar Jerib Avenue, Isfahan.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Skin disease and Leishmaniasis Research Center, Isfahan University of Medical Sciences
Full name of responsible person
Dr Sadaf Farhadi
Position
Assistant of dermatology
Other areas of specialty/work
Street address
Department of dermatology, Al Zahra Hospital , Soffeh Blvd
City
Isfahan
Postal code
8179604891
Phone
+98 31 3785 0842
Fax
Email
sadaffarhadi@resident.mui.ac.ir www.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin disease and Leishmaniasis Research Center, Isfahan University of Medical Sciences
Full name of responsible person
Dr Fariba Iraji
Position
professor
Other areas of specialty/work
Street address
Department of Dermatology, Al Zahra Hospital, Soffeh Blvd, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+31 34650038
Fax
Email
iraji@med.mui.ac.ir www.med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Skin disease and Leishmaniasis Research Center, Isfahan University of Medical Sciences
Full name of responsible person
Dr Sadaf Farhadi
Position
Assistant of Dermatology
Other areas of specialty/work
Street address
Department of Dermatology, Al-Zahra Hospital, Soffeh Blvd, Isfahan
City
Isfahan
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)