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Comparison of the effect of topical betamethasone with oral melatonin in the treatment of atopic dermatitis

Protocol summary

Study aim
Determining and comparing the effect of topical betamethasone with oral melatonin in the treatment of atopic dermatitis
Design
A randomized, double-blinding clinical trial, with the parallel groups, Phase 3 on 50 patients
Settings and conduct
In this randomized double-blind clinical trial study, 50 patients referred to Alzahra and Sedigheh Tahereh hospitals in Isfahan will be included in the study and randomly divided into two groups. One group will receive the usual treatment with melatonin tablets and the other group will receive the usual treatment with placebo tablets. Then the scaling severity, blister severity, redness severity, and dermatitis severity of patients will be evaluated and compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 18-65 years and consent to participate in the study. Non inclusion criteria: extent of involvement less than 2% or more than 30% of the body surface, skin problems other than atopic dermatitis, severe systemic diseases (kidney disease, diabetes, uncontrollable hypertension, and other chronic diseases), consumption of systemic medications for atopic dermatitis 4 weeks before the start of the study, use of topical medications for atopic dermatitis 2 weeks before the start of the study.
Intervention groups
Intervention group: In this group, patients receive topical betamethasone and an emollient twice a day. They are also prescribed an oral melatonin 3 mg tablet at bedtime. Control group: In this group, patients receive topical betamethasone and an emollient twice a day. They are also prescribed a placebo tablet (which looks similar to melatonin).
Main outcome variables
Scaling severity; Blister severity; Redness severity; Dermatitis severity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200825048515N23
Registration date: 2021-02-14, 1399/11/26
Registration timing: prospective

Last update: 2021-02-14, 1399/11/26
Update count: 0
Registration date
2021-02-14, 1399/11/26
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-18, 1399/11/30
Expected recruitment end date
2021-05-20, 1400/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of topical betamethasone with oral melatonin in the treatment of atopic dermatitis
Public title
The effect of topical betamethasone and oral melatonin in the treatment of atopic dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-65 years Satisfaction to participate in the study
Exclusion criteria:
Extent of involvement less than 2% or more than 30% of the body surface Skin problems other than atopic dermatitis Severe systemic diseases (kidney disease, diabetes, uncontrolled hypertension, and other chronic diseases) Use of systemic medications for atopic dermatitis 4 weeks before the start of the study Use of topical medications for atopic dermatitis 2 weeks before the start of the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Data analyser
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 50 eligible patients will be randomly selected. Then, these patients will be randomly encoded using computer software called "Random Allocation" and automatically divided into two groups. The relevant codes will be entered in the raw checklists and each of these checklists will be randomly assigned to one patient and that patient will be randomly assigned to one of the two study groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the two drugs melatonin and placebo of the same color and shape are prepared by the pharmacist and placed in coded packages and given to the doctor. He prescribes them without knowing the type of each drug. Also, the person recording the patient's clinical information and the statistical analyst will not be aware of the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2020-08-22, 1399/06/01
Ethics committee reference number
IR.MUI.MED.REC.1399.422

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
Scaling severity
Timepoint
4, 8 and 12 weeks and 3 months after intervention
Method of measurement
Scoring Index for Atopic Dermatitis (SCORAD)

2

Description
Blister severity
Timepoint
4, 8 and 12 weeks and 3 months after intervention
Method of measurement
Scoring Index for Atopic Dermatitis (SCORAD)

3

Description
Redness severity
Timepoint
4, 8 and 12 weeks and 3 months after intervention
Method of measurement
Scoring Index for Atopic Dermatitis (SCORAD)

4

Description
Dermatitis severity
Timepoint
4, 8 and 12 weeks and 3 months after intervention
Method of measurement
Scoring Index for Atopic Dermatitis (SCORAD)

Secondary outcomes

empty

Intervention groups

1

Description
Control group: In this group, patients receive topical betamethasone and an emollient twice a day. They have also prescribed a placebo tablet (which looks similar to melatonin) at bedtime.
Category
Placebo

2

Description
Intervention group: In this group, patients receive topical betamethasone and an emollient twice a day. They have also prescribed an oral melatonin 3 mg tablet at bedtime.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Fariba Iraji
Street address
Skin department; Al-Zahra Hospital; Al-Zahra Educational and Medical Center; Soffah boulevard; Shahid Keshvari highway
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
iraji@med.mui.ac.ir

2

Recruitment center
Name of recruitment center
Sedigheh Tahereh Clinic
Full name of responsible person
Fariba Iraji
Street address
Dermatology Department, Sedigheh Tahereh Clinic, Khoram street
City
Isfahan
Province
Isfehan
Postal code
8139946111
Phone
+98 31 3335 9797
Email
iraji@med.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Fariba Iraji
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Skin department; Al-Zahra Hospital; Al-Zahra Educational and Medical Center; Soffah boulevard; Shahid Keshvari highway
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
iraji@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fariba Iraji
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Skin department; Al-Zahra Hospital; Al-Zahra Educational and Medical Center; Soffah boulevard; Shahid Keshvari highway
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
iraji@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Saeid Karami
Position
general physician
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Skin department; Al-Zahra Hospital; Al-Zahra Educational and Medical Center; Soffah boulevard; Shahid Keshvari highway
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
saeidkarami3372@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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