This study is a randomized, placebo-controlled, double-blind trial in 120 patients with atopic dermatitis aged 18 years to 65 years with poor response to conventional treatment (topical steroids and oral antihistamines) at dermatology clinic of Afzalipour hospital in Hamadan. After confirmation of atopic dermatitis by dermatologist and the same drug prescription, all Patients will be randomly allocated into two groups according to Random number tables. Intervention group will receive topical mirtazapin 5% four times a day for 10 days with topical betamethason and control group will receive topical betamethason without mirtazapin. Severity of clinical symptoms and pruritus determine by visual analogue scale at baseline, 5 days and 10 days after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015071722965N3
Registration date:2015-11-04, 1394/08/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-04, 1394/08/13
Registrant information
Name
Maryam Mehrpooya
Name of organization / entity
School of Pharmacy,Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3821 8684
Email address
m.mehrpoya@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Hamadan University of Medical Sciences
Expected recruitment start date
2015-09-01, 1394/06/10
Expected recruitment end date
2016-09-01, 1395/06/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of topical mirtazapine on management of pruritus in patient with eczema
Public title
Effect of topical mirtazapine on eczema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Age between 18-65 years old; Moderate to severe eczema; Patients who less than 25% of their skin is involved; Discountinue of glucocorticoid agents 4 weeks prior to the investigation; Discountinue of anti puritis agents 1 week prior to the investigation
Exclusion criteria: Age less than 18 years old; Patients with inflammatory skin disease; Pregnant woman
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Neither the participants or the experimenters know who is receiving a particular treatment
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Khajerashid, Ayatollah kashani,Hamadan University of Medical Sciences
City
Hamadan
Postal code
Approval date
2015-05-20, 1394/02/30
Ethics committee reference number
IR.UMSHA.REC.1394.233
Health conditions studied
1
Description of health condition studied
Atopic dermatitis
ICD-10 code
L20.8
ICD-10 code description
Other atopic dermatitis
Primary outcomes
1
Description
Eczema
Timepoint
5 and 10 days following of treatment
Method of measurement
Visual Analogue Score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Betamethason cream plus mitazapine 5% cream 4 times per day for 10 days
Category
Treatment - Drugs
2
Description
Control group:
Betamethason cream plus placebo mitazapine 5% cream 4 times per day for 10 days