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IRCT20201101049215N1 IRCT 2020-11-22 Shiraz University of Medical Sciences Effect of Gammalinolenic acid in hand eczema 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 2019-11-22 anticipated 52 Complete https://irct.ir/trial/52017 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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, Randomization description: Randomization is based on the permutation block method with four blocks in each group, randomization list was prepared for this purpose, 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. 3 Hand eczema. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Participants personal data, All the data is potentially available after making the people unrecognizable When: Start access 6 months after print result To whom: researchers employed in academic and scientific institutions Conditions: Research use of the data of this study is allowed communication in the manner of e-mail Where to obtain: web page of Shiraz University of Medical Sciences, Research unit Shahid Faghihi hospital, dermatology clinic, department office E-mail nedazakeri@yahoo.com How to obtain: After reviewing their written request, the data is given to them as soon as possible Comments:
public Farideh Jokar
Dermatology clinic, Shahid Faghihi hospital, Karimkhan Zand Ave., Shiraz
Shiraz Iran (Islamic Republic of) 7134846114 +98 71 3212 5239 nedazakeri@yahoo.com Shiraz University of Medical Sciences scientific Farideh Jokar
Dermatology clinic, Shahid Faghihi hospital, Karimkhan Zand Ave., Shiraz
Shiraz Iran (Islamic Republic of) 7134846114 +98 71 3212 5239 nedazakeri@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Chronic or subacute hand eczema, unilateral or bilateral 18 years 60 years Both 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 XII Disease of the skin and subcutaneous tissue Treatment - Drugs Treatment - Drugs 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. 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. 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. Research Deputy of Shiraz University of Medical Sciences Shiraz University of Medical Sciences Research Deputy of Shiraz University of Medical Sciences Approved 2019-10-09 Ethics committee of Shiraz University of Medical Sciences Ethics committee of Shiraz University of Medical Sciences, University of Medical Sciences Building, Karimkhan Zand Ave., Shiraz Shiraz Fars Iran (Islamic Republic of)