Infantile atopic eczema is an inflammatory lesion that usually involves the epidermis of the skin and almost 50% of all children are affected in the first years of their life. Most of interventions and treatments have explored the effects of probiotics and synthetic drugs on atopic eczema and less attention has been to complementary, traditional and alternative medicines. The aim of current study was comparing topical application of human breast milk and Hydrocortisone ointment 1% on healing of infantile atopic eczema. A randomized controlled clinical trial on 104 healthy infants with age of less than 20 months without having major diseases that needed long term treatments referred to Amiri Kabir Hospital at Arak city in 2011-2012. The infants were randomly divided into two groups (with using a coin); topical application of human breast milk (N=54) and Hydrocortisone ointment 1% (N=50). Human breast milk group used hind milk after each breastfeeding and other group used Hydrocortisone ointment 1% two times daily. For assessment of extent and severity of eczema, we used objective SCORAD (SCORing Atopic Dermatitis) and PO SCORAD (Patient-Oriented SCORing Atopic Dermatitis) at days 0, 7, 14 and 21 in each group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201208313869N5
Registration date:2013-03-01, 1391/12/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-03-01, 1391/12/11
Registrant information
Name
Leila Amirifarahani
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1417 3524
Email address
l.amirifarahani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2011-07-25, 1390/05/03
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of topical application of human breast milk and Hydrocortisone ointment 1% on healing of infantile atopic eczema
Public title
Effect of topical application of human breast milk on treatment of infants eczema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having less than 20 months and atopic eczema
Exclusion criteria:having major diseases that needed long term treatments
Age
To 2 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Sardash, Arak
City
Arak
Postal code
Approval date
2011-07-04, 1390/04/13
Ethics committee reference number
90-109-5
Health conditions studied
1
Description of health condition studied
Infantile atopic dermatitis
ICD-10 code
L20
ICD-10 code description
Atopic dermatitis
Primary outcomes
1
Description
Extent of infantile atopic eczema
Timepoint
Before intervention and days 7, 14 and 21 after intervention
Method of measurement
Using objective SCORAD and PO SCORAD
Secondary outcomes
1
Description
Severity of infantile atopic eczema
Timepoint
Before intervention and days 7, 14 and 21 after intervention
Method of measurement
Using objective SCORAD and PO SCORAD
Intervention groups
1
Description
Intervention group used topical application of human breast milk (hind milk) after each breastfeeding
Category
Treatment - Other
2
Description
Control group used Hydrocortisone ointment 1% two times daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak University of Medical Sciences
Full name of responsible person
Leila Amiri Farahani
Street address
Arak University of Medical Sciences, Sardasht, Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences
Full name of responsible person
Dr Saeed Changizi Ashtyani
Street address
Arak University of Medical Sciences, Sardash, Arak, University of Medical Sciences Vice chancellor for research, Dr Saeed Changizi Ashtyani
City
Arak
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, Arak 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
Arak University of Medical Sciences
Full name of responsible person
Leila Amiri Farahani
Position
Member of faculty/MSc
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Sardasht, Arak
City
Arak
Postal code
Phone
+98 86 1417 3524
Fax
Email
l.amirifarahani@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Leila Amiri Farahani
Position
Member of faculty/ MSc
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Sardasht, Arak
City
Arak
Postal code
Phone
+98 86 1417 3524
Fax
Email
l.amirifarahani@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Leila Amiri Farahani
Position
Member of faculty/ MSc
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Sardasht, Arak
City
Arak
Postal code
-
Phone
+98 86 1417 3524
Fax
+98 86 1417 3524
Email
l.amirifarahani@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)