A randomized clinical trial among children under 2 years with complaint of diaper dermatitis who has been visited as out patients in bandar abbas children hospital who has inclusion criteria for enrolment in this study.
Diagnostic criteria . macule , papule,plaque,vesicle,desqumation, maceration over inner side of thigh or buttock also lower part of abdomen.
To determine severity, each of skin lesion received one point and according to the scores divided patients in three category: mild with score of 1, moderate with score of 2 and severe with score of 3 and more
164 Patients with maximum age of 2 years old who has been admited in out patient department of Bandar Abbas Children|s Hospital with coplaint of Diaper Dermatitis randomly would be divided by random digit table into 4 groups ( 41 patients in each group) and Respectively would receive Clotrimazol(twice daily), Mupirucin ( 4 times a day), Nystatin ( three times a day) or zinc oxide ( 4 times a day) pluse Hydrocortison ( 3 times a day) for one week and they would be visited by their doctor's.
According to response to treatment they would be divided in three groups with the same scale we used to determine severity of dermatitis. Complete relief ( score zero) ,partially treated ( score 1-2), no response (score 3 and more)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013112215458N1
Registration date:2015-03-26, 1394/01/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-03-26, 1394/01/06
Registrant information
Name
Rakhshane Goodarzi
Name of organization / entity
Hormozgan University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 76 1666 6242
Email address
rgoodarzi@oldhums.ac.ir
Recruitment status
Recruitment complete
Funding source
Hormozgan University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative trial of three medicines including: Nystatin,Cloterimazole and Mupirocine to treat a diaper dermatitis.
Public title
Survey the effects of antifungal medicines for treatment of napkin dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
1. Age 0-2 years
2.minimum severity score 1
3 duration less than 6 weeks
Exclusion Criteria:
1.Duration of disease more than 6 weeks
2. Another Perineal diseases like Psoriasis, Perineal infection , Perineal or genital wart, contact allergic dermatiti
3. congenital immunodeficiency diseases
4.Previous Treatment with clotrimazole,Nystatin,Mupirocine,hydrocortison except zinc oxide within 2 weeks before enrollment
5.Allergy to Clotrimazol, Nystatin, Zinc oxide,Mupirocine,hyrdocortison
6.treatment with systemic corticosteroid,Antifungal or Antibiotic during study
Age
To 2 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
164
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
HEC
Street address
Homozgan University of Medical Sciences
City
Bandar Abbas
Postal code
Approval date
2013-08-12, 1392/05/21
Ethics committee reference number
HEC-92-5-21-1
Health conditions studied
1
Description of health condition studied
Diaper(Napkin) Dermatitis
ICD-10 code
L22
ICD-10 code description
Diaper or Napkin: erythema rash
Primary outcomes
1
Description
sevierty of dermatitis To determine severity, each of skin lesion received one point and according to the scores divided patients in three category: mild with score of 1, moderate with score of 2 and severe with score of 3 and more
Timepoint
baseline and one week after study
Method of measurement
According to response to treatment they would be divided in three groups with the same scale we used to determine severity of dermatitis. Complete relief ( score zero) ,partially treated ( score 1-2), no response (score 3 and more)
Secondary outcomes
1
Description
medication side effect, extension of dermatitis
Timepoint
baseline and 1 week after study
Method of measurement
Checklist
Intervention groups
1
Description
Control Group:
Zinc Oxide Cream four times a day plus Hydrocortison Cream three times a day for one week .
1FTU(one Finger Tube Unite equal to Distal phalanx of index finger )for an area of skin on a child equivalent to twice the size of the palmar
Category
Treatment - Drugs
2
Description
Intervention Group 1:
Clotrimazol Cream two times daily plus Hydrocortisone Cream Three times a day for one week .
1FTU(one Finger Tube Unite equal to Distal phalanx of index finger )for an area of skin on a child equivalent to twice the size of the palmar
Category
Treatment - Drugs
3
Description
Intervention Group 2:
Nystatin Cream two times daily plus Hydrocortisone Cream Three times a day for one week .
1FTU(one Finger Tube Unite equal to Distal phalanx of index finger )for an area of skin on a child equivalent to twice the size of the palmar
Category
Treatment - Drugs
4
Description
Intervention Group 3:
Mupirocin Cream four times daily plus Hydrocortisone Cream Three times a day for one week .
1FTU(one Finger Tube Unite equal to Distal phalanx of index finger )for an area of skin on a child equivalent to twice the size of the palmar
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bandar Abbas Children's Hospital
Full name of responsible person
Dr.Rakhshane Goodarzi
Street address
City
BandarAabbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Dr.Rakhshane Goodarzi
Street address
Hormozgan University of Medical Sciences
City
Bandar Abbas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hormozgan 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
Hormozgan Univesity of Medical siences
Full name of responsible person
Dr.Mohammad Mehdi Houshmandi
Position
Pediatrics
Other areas of specialty/work
Street address
Bandar Abbas Children's Hospital
City
Bandar Abbas
Postal code
Phone
+98 76 1666 6240
Fax
+98 76 1666 6241
Email
mhoushmandi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Dr.Rakhshane Goodarzi
Position
Neonatologist, Academic Staff
Other areas of specialty/work
Street address
Bandar Abbas Children's Hospital
City
Bandar Abbas
Postal code
Phone
+98 76 1666 6240
Fax
+98 76 1666 6241
Email
Rgoodarzi@oldhums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Dr.Rakhshane Goodarzi
Position
Neonatologist, Academic Staff
Other areas of specialty/work
Street address
Bandar Abbas Children's Hospital
City
Bandar Abbas
Postal code
Phone
+98 76 1666 6240
Fax
+98 76 1666 6241
Email
Rgoodarzi@oldhums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)