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Evaluating the efficacy of corticosteroid free ointment in the treatment of patient with eczema

Protocol summary

Study aim
The main goal of this project is to investigate the effect of corticosteroid-free ointment (containing suaeda seed oil containing 77% omega-6 + biotin, pyridoxamine phosphate + cobalamin B12 + vitamin E + zinc oxide and calamine powder) On mild to moderate eczema skin disorders as well as evaluation of possible side effects of this product.
Design
Double blinded randomized (block randomization) phase 3 clinical trial with control group
Settings and conduct
Based on the results of the animal phase and human case studies, treatment duration of 21 days and 3 times per day is suggested. Also to check for side effects of this product, again check for symptoms of anti-eczema effects, for example, whether there is more inflammation, itching, redness and burning. Finally, the data were analyzed by SPSS software using ANOVA test. In this study, the outcome assessor and participants have been blinded. The outcome assessor is people who are responsible for gathering data and outcome variables and does not know which participant received which drug.
Participants/Inclusion and exclusion criteria
Only patients with active eczema lesion are included in this study.
Intervention groups
Three treatment groups are used to implement this scheme. By the way, the ointments given to people are similar in shape and color, 1) A group formulated with ointment containing active ingredients, 2) A group of ointments used without active ingredients and 3) A group that uses standard ointments such as eucerin. In this study, 25 individuals were used in each group using statistical calculations.
Main outcome variables
1) no itching, 2) no redness, 3) no burning, 4) less inflammation, and 5) wound healing.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140624018210N10
Registration date: 2020-12-13, 1399/09/23
Registration timing: registered_while_recruiting

Last update: 2020-12-13, 1399/09/23
Update count: 0
Registration date
2020-12-13, 1399/09/23
Registrant information
Name
Elham Behrangi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 2040
Email address
behrangi.e@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-01, 1399/09/11
Expected recruitment end date
2021-03-01, 1399/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the efficacy of corticosteroid free ointment in the treatment of patient with eczema
Public title
Formulation and manufacturing of corticosteroid free ointment for treatment of eczema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Only patients with active eczema lesions are included in this study.
Exclusion criteria:
Patients with very large (severe) lesions Patients with a history of skin diseases other than eczema
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization is a commonly used technique in clinical trial design to reduce bias and achieve balance in the allocation of participants to treatment arms. This method increases the probability that each arm will contain an equal number of individuals by sequencing participant assignments by block.The randomization unit is individual and randomization's tool is a statistical software.randomization is a simple method using statistical software SPSS version 22.Both drugs are packaged in the same container of 100 grams. The randomization list is prepared by a statistical consultant and a number is given to each medicine container. The participant and the main researcher and the doctor who is responsible for following up the patient and evaluating the outcome of the drug use are not aware of the nature of the drug used.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the outcome assessor and participants have been blinded. The outcome assessor is people who are responsible for gathering data and outcome variables and does not know which participant received which drug.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Iran University Of Medical sience
Street address
Iran university -Hemat Highway
City
Tehran
Province
Tehran
Postal code
19922347512
Approval date
2020-11-30, 1399/09/10
Ethics committee reference number
IR.IUMS.REC.1399.946

Health conditions studied

1

Description of health condition studied
eczema
ICD-10 code
L20.89
ICD-10 code description
Other atopic dermatitis

Primary outcomes

1

Description
1) itching 2) redness 3) burning 4) inflammation 5) wound healing
Timepoint
End of the treatment period
Method of measurement
Clinical examination

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: A group treated with formulated ointment containing active ingredients . Formulation:1)First, dissolve 8 grams of carbomer in one and a half liters of water and then bring the dissolved carbomer to a temperature of 70 degrees Celsius.2)In the next step, sterile acetyl alcohol + acetyl alcohol + liquid paraffin + GMS 32 g + stearate 20, + dimethicone + Vaseline is added and placed on the heater to dissolve completely.3)The active ingredients are weighed on the scales and added to the container, respectively. The active ingredients: omega 6 (linoleic acid) + zinc oxide + biotin + vitamin B6 + vitamin B12 + menthol were added one gram. It should be noted that the active ingredients are micronized4)Then items 1 and 2 were mixed together and homogenized with a homogenizer and finally triethanolamine was added.5)Methyl isothiosolonium preservative was added for 400C. all patients have signatured informed consent documents and were given a complete explanation about the sudy procedures .after the first visit and examination, patients would start the treatment period and after a month of treatment would be re-examined for treatment efficacy and followup checkups. treatment dosage is variable from 2 to 10 gr and should be administred on the lesion two times per day. oinment administration procedure is dependent on lesion size and each patient should use the oinment based on their lesion size in a manner that the surface of lesion shoud be fully covered with the oinment. The place of cream formulation has been done in Oud Kala factory (Alborz province, Baharestan town, Golestan 10th, Oud Kala factory (health-pharmaceutical products factory))
Category
Treatment - Drugs

2

Description
Intervention group: A group that uses standard ointments such as eucerin
Category
Treatment - Drugs

3

Description
Control group: A group treated with ointments without active ingredients
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasool-ٍE-Akram Hospital
Full name of responsible person
Dr Elham Behrangi
Street address
Satarkhan st , Tehran
City
Tehran
Province
Tehran
Postal code
1313114456
Phone
+98 21 6435 2421
Email
behrangi.e@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Sayed Abbas Motevalian
Street address
Iran University of Medical Siences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6435 2503
Email
amotevalian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Islamic Azad University
Full name of responsible person
Dr. Nuredin Bakhtiari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Tehran - Shahid Babaei Highway (west to east) - Hakimiyeh exit - Shahid Sadoughi St. - Shahid Abbaspour Boulevard - Islamic Azad University North Tehran Branch
City
Tehran
Province
Tehran
Postal code
1493889878
Phone
+98 21 4476 4532
Fax
+98 21 6650 2040
Email
nuredin1480@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Elham Behrangi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Dermatology Department,Rasool-Akram-Hospital,Satarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6650 2040
Fax
+98 21 6650 2040
Email
behrangi.e@iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Danesh Aminpanah
Position
Employee
Latest degree
Bachelor
Other areas of specialty/work
Biochemistry
Street address
Dermatology Department,Rasool Hospital,Satarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6650 2040
Fax
+98 21 6650 2040
Email
daneshaminpanah6374@gmail.com
Web page address

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
No - There is not a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
Findings of the study, demographic data of participants in the study, in addition to descriptive and analytical analysis of variables
When the data will become available and for how long
Availability 6 months after the end of study
To whom data/document is available
no limitation
Under which criteria data/document could be used
In the case of comparison with other similar trials or treatment
From where data/document is obtainable
Iran University of Medical Sciences
What processes are involved for a request to access data/document
By referring to the central library of Iran University of Medical Sciences can access to the text of the final report or article.
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