Comparison of therapeutic effect of topical GAMMANOL cream- contains 6% gamma linolenic acid- with mometasone 0/1% cream in hand eczema by two scoring systems of DLQI and HECSI in patients with chronic or subacute hand eczema
Comparison the therapeutic effect of Gammanol cream containing 6% gammalinolenic acid with mometasone cream in hand eczema
Design
Clinical trial with control group, two arm parallel group, double blinded, randomized, phase 3 on 52 patients. Randomization was based on the permutation block method with four block.
Settings and conduct
Patients with chronic or subacute hand eczema receive a number, according to the referral time. Two kinds of drugs consist of Gammanol cream and mometasone cream are packed in the bottles with the same shape and weight and are randomized based on the permutation block method. Every patient is given the drug with the same number. The patients, the main investigator physician and the physician who is responsible for follow up have no information about kind of the drug. Two indexes of DLQI and HECSI are measured in the first visit and after 1 month of regular drug use and the changes are evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: chronic or subacute hand eczema, unilateral or bilateral.
Exclusion criteria: pregnancy or lactation.
Intervention groups
Patients with chronic or subacute hand eczema are divided in two groups of 26 patients, to use Gammanol cream or mometasone cream. Both drugs are packed in bottles with the same shape and each one weighs 30gr. Patients are given a number based on the referral time and also , each drug has a number based on the randomization list and each patients is given the drug with the same number.
Main outcome variables
Hand eczema severity score; dermatologic life quality index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201101049215N1
Registration date:2020-11-22, 1399/09/02
Registration timing:registered_while_recruiting
Last update:2020-11-22, 1399/09/02
Update count:0
Registration date
2020-11-22, 1399/09/02
Registrant information
Name
Farideh Jokar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3212 5239
Email address
nedazakeri@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effect of topical GAMMANOL cream- contains 6% gamma linolenic acid- with mometasone 0/1% cream in hand eczema by two scoring systems of DLQI and HECSI in patients with chronic or subacute hand eczema
Public title
Effect of Gammalinolenic acid in hand eczema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic or subacute hand eczema, unilateral or bilateral
Exclusion criteria:
Acute hand eczema
pregnant or lactating women
Use systemic immunosuppressant drug for one recent month
Use topical therapies for hand eczema for two recent weeks
To have localized infection in hands
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is based on the permutation block method with four blocks in each group, randomization list was prepared for this purpose.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs in this trial are Mometasone 0.1% cream and Gammanol cream containing 6% gammalinolenic acid; both drugs are packed in bottles with the same shape and each one weighs 30 gr. Statistic advisor prepares a randomization list and each bottle is given a number. The participant, the main investigator, and the physician who is responsible for follow up and evaluating the outcome of drug use, have no information about the kind of drug.
Placebo
Not used
Assignment
Parallel
Other design features
In this study we compare the therapeutic effect of gammalinolenic acid with mometasone which is the main and common therapy for hand eczema.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Ethics committee of Shiraz University of Medical Sciences, University of Medical Sciences Building, Karimkhan Zand Ave., Shiraz
City
Shiraz
Province
Fars
Postal code
7185996187
Approval date
2019-10-09, 1398/07/17
Ethics committee reference number
IR.SUMS.MED.REC.1398.431
Health conditions studied
1
Description of health condition studied
Hand eczema
ICD-10 code
XII
ICD-10 code description
Disease of the skin and subcutaneous tissue
Primary outcomes
1
Description
Han Eczema Severity Score and Dermatology Life Quality Score
Timepoint
First visit and after one month of drug use
Method of measurement
measurement table of hand eczema severity index and questionnaire of dermatologiy life quality index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 26 patients with chronic and subacute hand eczema who receive Gammanol cream containing 6% gammalinolenic acid, manufactured by Asacpharma company, at the rate of 30 grams. Patients must use this cream for one month, the dosage is explained to the patients during a ten minute session by Finger Tip Unit. Finger Tip Unit of a cream is equivalent to 0.5 gram for each hand and finally 30 gram is used during one month for both hands.
Category
Treatment - Drugs
2
Description
Control group: 26 patients with chronic and subacute hand eczema who receive the standard and usual therapy which is mometasone 0.1% cream, at the rate of 30 grams. Patients must use this cream for one month, the dosage is explained to the patients during a ten minute session by Finger Tip Unit. Finger Tip Unit of a cream is equivalent to 0.5 gram for each hand and finally 30 gram is used during one month for both hands.
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
Participants personal data, All the data is potentially available after making the people unrecognizable
When the data will become available and for how long
Start access 6 months after print result
To whom data/document is available
researchers employed in academic and scientific institutions
Under which criteria data/document could be used
Research use of the data of this study is allowed
communication in the manner of e-mail
From where data/document is obtainable
web page of Shiraz University of Medical Sciences, Research unit
Shahid Faghihi hospital, dermatology clinic, department office
E-mail
nedazakeri@yahoo.com
What processes are involved for a request to access data/document
After reviewing their written request, the data is given to them as soon as possible