Objectives: The objective of this study is evaluation of efficacy of marshmallow ointment in comparison with topical hydrocortisone on children with atopic dermatitis.
Design: This is a double-blinded clinical trial study with a 22 sample size that done new cases of mild to mod atopic dermatitis with ages ranging from 3 months to 12 years old age in two therapeutic groups (marshmallow and hydrocortisone) by using permuted blocks.
Setting and conduct: Patients apply medications three a day and follow in a 4-week period.
Participants including major eligibility criteria: Inclusion criteria: 1) The age of patients range from 3 months to 12 year 2) The patient has no history of contact dermatitis to prescription drugs 3) Patients with acute infection is localized 4) According to the SCORAD severity of the disease is between 50-25. Exclusion criteria: changes in the level and score of SCORAD.
Intervention: One group of patients receive marshmallow cream (1%) and the other one hydrocortisone ointment (1%). Patients in both groups receive the drug three times a day.
Main outcome measures: Disease severity measure based on the criteria SCOARD in the first day, the seventh day, the thirtieth day
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2017020831205N2
Registration date:2017-04-03, 1396/01/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-03, 1396/01/14
Registrant information
Name
Mohsen Naseri
Name of organization / entity
Traditional Iranian Medicine Clinical Trial Research
Country
Iran (Islamic Republic of)
Phone
+98 21 2288 2596
Email address
r.jafari.hajati@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Shahid Beheshti University of Medical Sciences and Health Services, Tehran
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of efficacy of marshmallow ointment (1%) in comparison with topical hydrocortisone (1%) on children with atopic dermatitis
Public title
The effect of marshmallow and hydrocortisone ointment in children with atopic dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The age of patients ranged from 3 months to 12 year; The patient has no history of contact dermatitis to prescription drugs; Patients with acute infection is localized; According to the SCORAD severity of the disease is between 50-25.
Exclusion criteria: changes in the level and score of SCORAD
Age
From 3 months old to 12 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study is completely randomized block design.
Secondary Ids
1
Registry name
not used
Secondary trial Id
not used
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences and Health Services, Tehran
the first day intervention, the seventh day intervention, the thirtieth day intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
not used
Timepoint
not used
Method of measurement
not used
Intervention groups
1
Description
Intervention group 1: Receive marshmallow ointment (1%) three times a day.
This ointment produced by the School of Pharmacy, Shahid Beheshti University of Medical Sciences and Health Services in Tehran
Category
Treatment - Drugs
2
Description
control group: not used
Category
N/A
3
Description
Intervention group 2: Receive hydrocortisone ointment (1%) three times a day.
This ointment produced by the School of Pharmacy, Shahid Beheshti University of Medical Sciences and Health Services in Tehran
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Immunology and Allergy Clinic of Mofid Hospital
Full name of responsible person
Dr. Vahede Naseri
Street address
Before Mirdamad, Above Hoseynieh Ershad, Shariai street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences and Health Services,