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Comparison of efficacy of Tacrolimus 0.03% ointment with Mometason ointment in treatment of pediatric Atopic Dermatitis

Protocol summary

Study aim
Comparison of therapeutic effect of Tacrolimus 0.03% ointment and Mometason ointment in the treatment of Atopic Dermatitis in children.
Design
This is a randomised, double _ blind, parallel _ group, controlled phase 3 study.In this study, 30 childs with Atopic Dermatitis will be randomly divided in to two groups of 15 in each, using Rand List software.The control group will recieve Mometason ointment and intervention group will recieve Tacrolimus 0.03% ointment.
Settings and conduct
Thirty childs with Atopic Dermatitis who will refer to Sina Hospital Dermatology clinic will randomly be assigned in to two groups of 15 subjects.Intervention group (Tacrolimus 0.03% ointment) and the control group (Mometason ointment).
Participants/Inclusion and exclusion criteria
Inclusion criteria: children 2-10 years old, children with lesion size up to 5 cm, children with limb lesions, children with mild to moderate lesions, children whose parents declare their full written informed consent to participate in this study.Exclusion criteria: children who have other skin conditions at the same time, children whose skin lesions are infected.
Intervention groups
Intervention group: Topical tacrolimus 0.03% ointment.in the intervention group, 15 childs with Atopic Dermatitis will be treated with Tacrolimus 0.03% ointment every 12 hours for 6 weeks.Control group: topical Mometason ointment.in the control group 15 childs with Atopic Dermatitis will be treated with Mometason ointment every 12 hours for 6 weeks.
Main outcome variables
Atopic Dermatitis lesions severity index, size of Atopic Dermatitis, patients symptoms, possible complications.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20091012002581N6
Registration date: 2019-11-25, 1398/09/04
Registration timing: prospective

Last update: 2019-11-25, 1398/09/04
Update count: 0
Registration date
2019-11-25, 1398/09/04
Registrant information
Name
Hamide Herizchi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 4650
Email address
herizchih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-06, 1398/09/15
Expected recruitment end date
2020-03-05, 1398/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of Tacrolimus 0.03% ointment with Mometason ointment in treatment of pediatric Atopic Dermatitis
Public title
Comparison of efficacy of Tacrolimus 0.03% ointment with Mometason ointment in treatment of pediatric Atopic Dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children 2-10 years old. Children whose lesion are up to 5 cm in size. Children with limb lesions. Children whose parents declare their full written informed consent to participate in this study. Children with mild to moderate lesions.
Exclusion criteria:
Children who have other skin conditions at the same time. Children whose skin lesions are infected.
Age
From 2 years old to 10 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization will be carried out on an individual basis by Rand List software.The allocation will be seated by an independent monitor and will not be broken until the end of the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
The investigator assessing outcome and analyzing the data will be blinded to treatment allocation until the end of the study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Daneshgah
City
Tabriz
Province
East Azarbaijan
Postal code
5142954481
Approval date
2019-11-11, 1398/08/20
Ethics committee reference number
IR.TBZMED.REC.1398.811

Health conditions studied

1

Description of health condition studied
Atopic Dermatitis
ICD-10 code
L20
ICD-10 code description
Atopic dermatitis

Primary outcomes

1

Description
Atopic Dermatitis lesions severity index
Timepoint
Weeks 0, 3, 6
Method of measurement
Observation

2

Description
Size of Atopic Dermatitis lesion
Timepoint
Weeks 0, 3, 6
Method of measurement
Ruler measurement

3

Description
Patient symptoms
Timepoint
Weeks 0, 3, 6
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Possible complications
Timepoint
Weeks 0, 3, 6
Method of measurement
Observation _ questionnaire

Intervention groups

1

Description
Intervention group: Topical Tacrolimus 0.03% ointment.in the intervention group,15 childs with Atopic Dermatitis will be treated with Tacrolimus 0.03% ointment every 12 hours for 6 weeks.
Category
Treatment - Other

2

Description
Control group: Topical Mometason ointment.in the control group 15 childs with Atopic Dermatitis will be treated with Mometason ointment every 12 hours for 6 weeks.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Hamideh Herizchi Ghadim
Street address
Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 8236 3549
Fax
+98 41 8406 3549
Email
Drherizchi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Ataa Mahmoudpour
Street address
Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 8236 3549
Email
Drherizchi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Hamide Herizchi Ghadim
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Azadi
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 8236 3549
Email
Drherizchi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Hamide Herizchi Ghadim
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Azadi
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 8236 3549
Email
Drherizchi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sedighe Jafari Majd
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Azadi
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 8236 3549
Email
sjafarimajd@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be shared after being unidentified.
When the data will become available and for how long
All any time
To whom data/document is available
It will be free for every one.
Under which criteria data/document could be used
There are no special conditions.
From where data/document is obtainable
Email: Drherizchi@yahoo.com, 09141168780, Dr Hamide Herizchi Ghadim, Dermatology Department - Sina Hospital - Azadi sreet - Tabriz.
What processes are involved for a request to access data/document
The request will be checked, then data will be sent by Email in 1 month.
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