Evaluation of the effect of oral melatonin versus placebo in controlling pruritus in patients with atopic dermatitis: a double-blind randomized clinical trial
To assess the effect of oral melatonin versus placebo in controlling pruritus in patients with atopic dermatitis
Design
This is a Phase III double-blind randomized clinical trial with a control group, in which eligible patients will be randomly assigned to the intervention and control groups using block randomization.
Settings and conduct
This study will be conducted at the Sina Hospital in Hamadan city, involving 60 eligible patients with atopic dermatitis. The patients will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 12 to 65 years; Atopic dermatitis.
Exclusion criteria:
Pregnancy or breastfeeding; Liver, kidney, nervous or immune system disease; Use of warfarin and fluvoxamine
Intervention groups
Intervention group:
Routine treatment includes combined urea 10% and Eucerin 90% ointment and fluocinolone 30% and Eucerin 70% ointment daily plus oral 3 mg melatonin supplement daily for 6 weeks.
Control group:
Routine treatment includes combined urea 10% and Eucerin 90% ointment and fluocinolone 30% and Eucerin 70% ointment daily plus oral placebo supplement daily for 6 weeks.
Main outcome variables
The intensity of itching, severity of atopic dermatitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N483
Registration date:2023-09-29, 1402/07/07
Registration timing:prospective
Last update:2023-09-29, 1402/07/07
Update count:0
Registration date
2023-09-29, 1402/07/07
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-12, 1402/07/20
Expected recruitment end date
2025-03-10, 1403/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oral melatonin versus placebo in controlling pruritus in patients with atopic dermatitis: a double-blind randomized clinical trial
Public title
Effect of oral melatonin in controlling pruritus in patients with atopic dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 12 to 65 years
Atopic dermatitis
Exclusion criteria:
Pregnancy or breastfeeding
Liver, kidney, nervous or immune system disease
Use of warfarin and fluvoxamine
Age
From 12 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random assignment of patients to the intervention and control groups will be carried out using block randomization. To achieve this, 60r sheets of paper will be prepared - 30 with the name of the intervention and 30 with the name of the control. These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. The process will be repeated until the desired sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both the medications and placebos will have the same shape. Consequently, patients will remain unaware of the type of intervention they receive. Moreover, the randomization process will be conducted by a separate individual from the one who examines the patients, ensuring that the examining person remains unaware of the intervention. Therefore, the trial will be conducted as a double-blind study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2023-07-22, 1402/04/31
Ethics committee reference number
IR.UMSHA.REC.1402.358
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
The intensity of itching
Timepoint
Before the intervention and then 2, 4 and 6 weeks after the intervention
Method of measurement
Using visual analog scale (VAS)
2
Description
Severity of atopic dermatitis
Timepoint
Before the intervention and then 2, 4 and 6 weeks after the intervention
Method of measurement
Using the Scoring Atopic Dermatitis tool (SCORAD)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment includes combined urea 10% and Eucerin 90% ointment and fluocinolone 30% and Eucerin 70% ointment daily plus oral 3 mg melatonin supplement daily for 6 weeks.
Category
Treatment - Drugs
2
Description
Control group: Routine treatment includes combined urea 10% and Eucerin 90% ointment and fluocinolone 30% and Eucerin 70% ointment daily plus oral placebo supplement daily for 6 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan Sina Hospital
Full name of responsible person
Dr. Ayda Nouri Danesh
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
aydanouridanesh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Ayda Nouri Danesh
Position
Resident of Dermatology
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
aydanouridanesh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Bahareh Ebrahimi
Position
Dermatologist
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
b.ebrahimi.4326@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
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