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IRCT20240614062122N1 IRCT 2024-06-29 Ahvaz University of Medical Sciences Effect of Olopatadine in treatment of hand eczema Comparison effect of Olopatadine %0.2 cream with Fluocinolone %0.025 cream in the treatment of hand eczema in patients 2024-07-06 anticipated 76 Complete https://irct.ir/trial/77396 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the allocation of patients to each of the treatment groups will be done by random method (the patients are divided into two groups A and B using the coin toss method and then using the table random numbers are assigned to each group, Blinding description: Both categories of drugs are in tubs with the same shape,indistinguishable for the patient and the researcher,and with the numbering that will be written on them by the Faculty of Pharmacy when both drugs are tubed.It will be provided to the patient and the researcher also has the role of clinical caregiver and outcome assessor and date analyst,so the researcher and the patient are kept blind. 2 Investigating the effect of Olopatadine cream on hand eczema. Intervention 1: Intervention group: 38 patients with hand eczema was treated with 0.2% Olopatadine cream ,and each patient applied 1 gram or one centimeter of the cream on the finger twice a day and rotated it on massage the eczema lesion. Olopatadine drug ,which was originally available in power form, was formulated by the Faculty of Pharmacy of Jundishapur University of Ahvaz in accordance with the American Pharmacopoeia and the principles of pharmaceutics and will be provided to the patient as a 0.2% cream in multi-layer laminated tubes with a label attached. Intervention 2: Intervention group: 38 patients with hand eczema was treated with Fluocinolone 0.025% cream ,and each patient applied 1 gram or one centimeter of the cream on the finger twice a day and rotated it on massage the eczema lesion. Fluocinolone cream is produced by Tehran Chemie Pharmaceutical Company ,and it is provided to the patients as a cream in multi-layer laminated tube similar to the cover of Olopatadine. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Pazyar Nader
No.143,Taef Apartment, West Dez Street ,Amaniyeh
Ahvaz Iran (Islamic Republic of) 6133864473 +98 61 3333 3609 ‫Dr.pazyar@gmail.com Ahvaz University of Medical Sciences scientific Pazyar Nader
No.143,Taef Apartment, West Dez Street ,Amaniyeh
Ahvaz Iran (Islamic Republic of) 6133864473 +98 61 3333 3609 ‫Dr.pazyar@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) All patients with a diagnosis of hand eczema ,(including all types of eczema in the acute phase )whose disease is confirmed by biopsy or a dermatologist's diagnosis The age of the patients is 18 years or older Consent to participate in the study 18 years no limit Both Pregnant and breastfeeding Systemic treatment has been done in the last 3 months or local treatment 2 weeks ago The place of use of the medicine is infectious L20.8 Other atopic dermatitis Treatment - Drugs Treatment - Drugs Intervention group: 38 patients with hand eczema was treated with 0.2% Olopatadine cream ,and each patient applied 1 gram or one centimeter of the cream on the finger twice a day and rotated it on massage the eczema lesion. Olopatadine drug ,which was originally available in power form, was formulated by the Faculty of Pharmacy of Jundishapur University of Ahvaz in accordance with the American Pharmacopoeia and the principles of pharmaceutics and will be provided to the patient as a 0.2% cream in multi-layer laminated tubes with a label attached. Intervention group: 38 patients with hand eczema was treated with Fluocinolone 0.025% cream ,and each patient applied 1 gram or one centimeter of the cream on the finger twice a day and rotated it on massage the eczema lesion. Fluocinolone cream is produced by Tehran Chemie Pharmaceutical Company ,and it is provided to the patients as a cream in multi-layer laminated tube similar to the cover of Olopatadine The severity score of the clinical symptoms of hand eczema using the Hand Eczema Severity Index ,as well as the evaluation of the severity of itching using the Neurologic Rating Scale. Timepoint: Measuring the intensity of the clinical symptoms of hand eczema using the Hand Eczema Severity Index and itching intensity using the Neurologic Rating Scale at the beginning of the study ,then every two weeks until the end of the study (for 3 months) and 4 weeks after the end of the study. Method of measurement: Hand Eczema Severity Index Neurologic Rating Scale. Ahvaz University of Medical Sciences Approved 2024-06-05 Ethics committee of Ahvaz Jondishapur University of Medical Sciences No.143,Taef Apartment, West Dez Street ,Amaniyeh Ahvaz Khouzestan Iran (Islamic Republic of)