In this randomized double blind clinical trial 70 patients with moderate to severe hand eczema entere our study considering inclusion and exclusion criteria and randomly divide in two groups.Inclusion criteria:all patients with moderate to severe hand eczema that are 12 to 70 years old
exclusion criteria:treatment with systemic steroid less than 1 month before trial;treatment with topical steroid and antihistamines at the time of presentation ;pregnancy;lactatation;age less than 12.one group receive topical steroid and doxepine 5% cream and the other use topical steroid and placebo twice a day for 8 days.Patients data such as demographic features, severity of clinical symptoms and pruritus collect by questionnaire.Hand eczema severity index and visual analogue scale are our criterion for determination of clinical symptoms and pruritus severity.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112018263N1
Registration date:2012-05-05, 1391/02/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-05-05, 1391/02/16
Registrant information
Name
Farideh Dehghani
Name of organization / entity
ُShahid Sadooghi University of Medical Sciences,Yazd
Country
Iran (Islamic Republic of)
Phone
+98 35 1525 0093
Email address
farideh.dehghan@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
ُShahid Sadooghi university of Medical Sciences,Yazd
Expected recruitment start date
2011-10-23, 1390/08/01
Expected recruitment end date
2012-08-20, 1391/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluating of clobetasol 0.05% and doxepine 5% cream vs clobetasol 0.05% and placebo in the treatment of moderate to severe hand eczema
Public title
evaluating of clobetasol 0.05% and doxepine 5% cream vs clobetasol 0.05% and placebo in the treatment of moderate to severe hand eczema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:all patients with moderate to severe hand eczema that are 12 to 70 years old
exclusion criteria:treatment with systemic steroid less than 1 month before trial;treatment with topical steroid and antihistamines at the time of presentation ;pregnancy;lactatation;age less than 12
Age
From 12 years old to 70 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ُShahid Sadooghi University of Medical Sciences,Yazd
Street address
central office of ُShahid Sadooghi University of Medical Sciences, Shahid Sadooghi blv,Yazd
City
Yazd
Postal code
Approval date
2012-02-27, 1390/12/08
Ethics committee reference number
153947/1/17/پ
Health conditions studied
1
Description of health condition studied
hand eczema
ICD-10 code
L20.8
ICD-10 code description
Other atopic dermatitis
Primary outcomes
1
Description
reduction or improvement of hand eczema
Timepoint
before and 8 days after treatment
Method of measurement
hand eczema severity index
Secondary outcomes
1
Description
adverse effects
Timepoint
8 days after initiation of treatment
Method of measurement
8 days after initiation of treatment
Intervention groups
1
Description
doxepine 5% cream and clobetasol 0.05% are applied twice a day for 8 days
Category
Treatment - Drugs
2
Description
clobetasol 0.05% and placebo are applied twice a day for 8 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Poly Clinic and subspecialty Khatamolanbia
Full name of responsible person
Farideh Dehghani, MD
Street address
Taleghani blv, Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
ُShahid Sadooghi University of Medical Sciences,Yazd
Full name of responsible person
Fatemeh Ezoddini, MD
Street address
central office of ُShahid Sadooghi university of Medical Sciences, Shahid Sadooghi blv,Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
ُShahid Sadooghi University of Medical Sciences,Yazd
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
ُShahid Sadooghi University of Medical Sciences,Yazd
Full name of responsible person
Farideh Dehghani, MD
Position
Assistant professor of dermatology
Other areas of specialty/work
Street address
Burn and Accident Hospital, Paknejad blv, Yazd
City
Yazd
Postal code
Phone
+98 35 1525 0093
Fax
Email
farideh.dehghan@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
ُShahid Sadooghi University of Medical Sciences,Yazd
Full name of responsible person
Farideh Dehghani, MD
Position
Assistant professor of dermatology
Other areas of specialty/work
Street address
Burn and Accident Hospital, Paknejad blv,Yazd
City
Yazd
Postal code
Phone
+98 35 1525 0093
Fax
Email
farideh.dehghan@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
ُShahid Sadooghi University of Medical Sciences,Yazd
Full name of responsible person
Farideh Dehghani, MD
Position
Assistant professor of dermatology
Other areas of specialty/work
Street address
Burn and Accident Hospital, Paknejad blv,Yazd
City
Yazd
Postal code
Phone
+98 35 1525 0093
Fax
Email
farideh.dehghan@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)