Protocol summary

Study aim
The aim of this study is to evaluate the effect of topical cholecalciferol in mild to moderate atopic eczema in patients aged 2 to 18 years.
Design
To compare the effect of the drug and the placebo, after determining the blood level of vitamin D, the patients will be divided into three groups of a least 10 persons: 1) Patients with vitamin D deficiency who receive oral vitamin D and ointment containing drug. 2) Patients who lack vitamin D deficiency are divided into two groups of drugs and placebo in two-blinded and randomized (using random sequences) models. From the time of admission to study, patients should use topical vitamin D 1,000 units per gram and placebo once a day for 8 weeks. Patients are required to refer to follow-up times at specified times (0,4,8) and after 8 weeks, photos and EASI are recorded.
Settings and conduct
Patients refer to Skin and Stem Cell Research Center and Children Medical Center Hospital, after determining the blood level of vitamin D, will divide into three groups of at least 10 persons: 1) Patients with vitamin D deficiency who receive oral vitamin D and ointment containing drug. 2) Patients who lack vitamin D deficiency are divided into two groups of drugs and placebo in two-blinded and randomized (using random sequences) models. From the time of admission to study, patients should use topical vitamin D 1,000 units per gram and placebo once a day for 8 weeks. Patients are required to refer to follow-up times at specified times (0,4,8) and after 8 weeks, photos and EASI are recorded.
Participants/Inclusion and exclusion criteria
inclusion criteria: 1) aged 2-18 in both genders 2) discontinuation of topical treatment at least 2 weeks ago and for patients who use systemic therapy, it should be stable for months (at least 2 months) and plaque lesions remain in the use of systemic therapy. 3) mild to moderate eczema; Exclusion criteria: 1) History of allergy to the compounds in the formulation and vitamin D3 derivatives 2) aged over 18 years 3) Hypervitaminosis D 4) hypercalcemia 5) Patients with acute eczema attack 6) The presence of skin infection or malignancy at the treatment site 7) The presence of diseases associated with vitamin D metabolism disorders
Intervention groups
Patients in the intervention group should use cholecalciferol 1000 unit per gram ointment once a day for 8 weeks on lesions. Patients in the control group should use a drug-free ointment once a day for 8 weeks on lesions. The placebo ointment contains 95% vaseline and 5% bee wax
Main outcome variables
1) Quality of Life 2) Eczema severity 3) adverse effects

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100119003106N36
Registration date: 2018-03-10, 1396/12/19
Registration timing: registered_while_recruiting

Last update: 2018-03-10, 1396/12/19
Update count: 0
Registration date
2018-03-10, 1396/12/19
Registrant information
Name
Farshad Hashemian
Name of organization / entity
Pharmaceutical Sciences Branch, Islamic Azad University (IAU)
Country
Iran (Islamic Republic of)
Phone
+98 21 2260 0037
Email address
hashemian.f@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effects of vitamin D3 (cholecalciferol) ointment on atopic eczema in patients 2-18 years old
Public title
Assessment of the effect of cholecalciferol ointment on atopic eczema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
aged 2-18 in both genders discontinuation of topical treatment at least 2 weeks ago and for patients who use systemic therapy, it should be stable for months (at least 2 months) and plaque lesions remain in the use of systemic therapy mild to moderate eczema
Exclusion criteria:
History of allergy to the compounds in the formulation and vitamin D3 derivatives aged over 18 years Hypervitaminosis D hypercalcemia Patients with acute eczema attack The presence of skin infection or malignancy at the treatment site The presence of diseases associated with vitamin D metabolism disorders
Age
From 2 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
This study was designed simple randomization method using random numbers table.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients with vitamin D in excess of 30 ng/ml received ointment and placebo in two-blinded manner. The ointments are coded by the Pharmaceutical Department of the College of Pharmacy (a and b) and the researcher, physicians, and patients do not know the contents of ointment.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University Of Pharmaceutical Sciences Branch
Street address
Islamic Azad University Of Pharmaceutical Sciences Branch,Yakhchal avenue,Shariati
City
Tehran
Province
Tehran
Postal code
193956466
Approval date
2017-01-05, 1395/10/16
Ethics committee reference number
IR.IAU.PS.REC.1395.48

Health conditions studied

1

Description of health condition studied
Atopic dermatitis
ICD-10 code
L20.9
ICD-10 code description
Atopic dermatitis, unspecified

Primary outcomes

1

Description
Quality of Life
Timepoint
beginning of the treatment, 4 weeks and 8 weeks after starting the treatment
Method of measurement
questionnaire

2

Description
Eczema severity
Timepoint
beginning of the treatment, 4 weeks and 8 weeks after starting treatment
Method of measurement
EASI

Secondary outcomes

1

Description
adverse effect
Timepoint
beginning of the treatment, 4 weeks and 8 weeks after starting treatment
Method of measurement
physician assessment

Intervention groups

1

Description
Patients in the control group should use a drug-free ointment once a day for 8 weeks on lesions.The placebo ointment contains 95% vaseline and 5% bee wax.
Category
Placebo

2

Description
Patients in the intervention group should use cholecalciferol 1000 unit per gram ointment once a day for 8 weeks on lesions.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Skin and Stem Cell Research Center
Full name of responsible person
Dr Parvin Mansouri
Street address
No 4 Maryam Dead End South Andarzgo Blvd, Kamraniyeh, Tehran
City
Tehran
Province
Tehran
Postal code
19395-6466
Phone
+98 21 2221 2537
Email
Afsaneh.najafi@yahoo.com

2

Recruitment center
Name of recruitment center
Children Medical Center Hospital
Full name of responsible person
Dr Mehdi Rajabi
Street address
Gharib Ave, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6692 2115
Email
rayehetavajohi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Pharmaceutical Sciences branch, Islamic Azad University
Full name of responsible person
Dr.Seyd Jalaledin Hosseini Ghoncheh
Street address
Islamic Azad University Of Pharmaceutical Sciences Branch، Yakhchal avenue، Dotor Shariati avenue
City
Tehran
Province
Tehran
Postal code
19395-6466
Phone
+98 21 2260 9043
Email
sjghoncheh@iaups.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pharmaceutical Sciences branch, Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University Of Pharmaceutical Sciences Branch
Full name of responsible person
Rayeheh Tavajjohi
Position
Student of pharmacy
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmaceutical Sciences Branch of Islamic Azad University، Yakhchal Avenue، Doctor Shariati Avenue، Tehran
City
Tehran
Province
Tehran
Postal code
19395-6466
Phone
+98 21 2264 0051
Fax
Email
rayehetavajohi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University Of Pharmaceutical Sciences Branch
Full name of responsible person
Dr Mehdi Rajabi
Position
Ph.D. in Clinical Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Islamic Azad University Of Pharmaceutical Sciences Branch، Yakhchal avenue، Dotor Shariati avenue، Tehran
City
Tehran
Province
Tehran
Postal code
19395-6466
Phone
+98 21 2264 0056
Fax
Email
mehdirj@aol.co.uk
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University Of Pharmaceutical Science Branch
Full name of responsible person
Rayeheh Tavajjohi
Position
Pharmacy student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmaceutical Sciences Branch of Islamic Azad University, Yakhchal Avenue, Doctor Shariati Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
19395-6466
Phone
+98 21 2264 0056
Fax
Email
rayehetavajohi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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