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IRCT20220519054920N1 IRCT 2023-01-25 Esfahan University of Medical Sciences The effect of two topical drugs fluorouracil 5% and niacin amide 1% in the treatment of patients with actinic keratosis Clinical trial of Comparison of the efficacy of two topical drugs fluorouracil 5% and niacin amide 1% in the treatment of patients with actinic keratosis 2023-01-20 anticipated 88 Complete https://irct.ir/trial/63730 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling is performed among patients referred to dermoscopy clinic affiliated to the esfahan university of medical science and if they have the conditions to enter and leave the study are considered as an sample. Random function of Excel software based on patient file number will be used for randomization. Patients with actinic keratois are entered in Excel according to the file number and are divided into two groups of fluorouracil and niacinamide based on the random button. 2 Actinic keratosis. Intervention 1: Intervention group 1:In the first group, 44 lesions are entered. First, the lesions of each patient are determined precisely by examination and using dermoscopy, then the lesions are photographed and 5% fluorouracil topical cream is prescribed for the patients. Patients use the medicine topically once a day and during a period of 4 weeks at the designated lesion site.The manufacturer of 5% fluorouracil cream is "Meda" company of Sweden. Intervention 2: Intervention group2 :In the second group, 44 lesions are included. First, each patient's lesions are determined precisely by examination and using dermoscopy, then the lesions are photographed and 1% niacinamide topical gel is prescribed for the patients. Patients use the drug twice a day for a period of 3 months at the site of the determined lesions.Niacinamide 1% topical gel is produced by a pharmacist in the form of niacinamide powder in the gel base. Yes - There is a plan to make this available What will be shared: Dissemination of data that has nothing to do with the personality and identity of the participants in the study and are merely the consequences of the study. When: Start the access period after the article is published To whom: The data will be available only to researchers working in academic and scientific institutions, after their authentication by the relevant university. Conditions: The data can only be used for research and writing review articles. Where to obtain: The author will be available via the email and university phone number mentioned in the article. How to obtain: Access to the data is granted if it is found that the data has been requested for non-industrial and non-commercial use. Comments:
public Mahbube Barati
Alzahra Hospital, Dermatology Department, Sofeh Street, Isfahan, Iran
esfahan Iran (Islamic Republic of) 8174645731 +98 31 3669 5414 mah.brti@yahoo.com Esfahan University of Medical Sciences scientific Mahbube Barati
Alzahra Hospital, Dermatology Department, Sofeh Street, Isfahan, Iran
esfahan Iran (Islamic Republic of) 8174645731 +98 31 3669 5414 mah.brti@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) New patients with actinic keratosis who have not yet received any medication Patients who have previously received topical medication and have not received topical medication in at least one month People aged 18 and over Non-hyperkeratotic lesions 18 years no limit Both Existence of other skin diseases at the treatment site History of hypersensitivity to fluorouracil or niacin acid Pregnant and lactating women L57.0 Actinic keratosis Treatment - Drugs Treatment - Drugs Intervention group 1:In the first group, 44 lesions are entered. First, the lesions of each patient are determined precisely by examination and using dermoscopy, then the lesions are photographed and 5% fluorouracil topical cream is prescribed for the patients. Patients use the medicine topically once a day and during a period of 4 weeks at the designated lesion site.The manufacturer of 5% fluorouracil cream is "Meda" company of Sweden. Intervention group2 :In the second group, 44 lesions are included. First, each patient's lesions are determined precisely by examination and using dermoscopy, then the lesions are photographed and 1% niacinamide topical gel is prescribed for the patients. Patients use the drug twice a day for a period of 3 months at the site of the determined lesions.Niacinamide 1% topical gel is produced by a pharmacist in the form of niacinamide powder in the gel base. Improvment rate. Timepoint: Before and after intervention. Method of measurement: Scoring based on the opinion of two dermatologists. Dermoscopic grading. Timepoint: Before and after intervention. Method of measurement: Based on scoring by two dermatologist. Complications of treatment. Timepoint: Weeks 4 and 8 in the fluorouracil group and weeks 6 and 12 in the niacinamid group. Method of measurement: Asking the patients. Esfahan University of Medical Sciences Approved 2021-09-04 Ethics committee of Esfahan University of Medical Sciences Faculty of Medicine, Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran esfahan Isfehan Iran (Islamic Republic of)