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IRCT20180909040978N1 IRCT 2018-10-19 Tehran University of Medical Sciences Evaluation of treatment of actinic keratosis with KOH5% solution in comparison to Fluorouracil 5% cream Evaluation of clinical and dermoscopic effects of topical use of KOH 5% solution on Actinic Keratosis and its comparison with 5-Fluorouracil topical cream on patients suffering Actinic Keratosis. 2018-10-22 anticipated 25 Complete https://irct.ir/trial/33936 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sides on which, each drug is used for each patient, is randomized using four-way Block Randomization method. Patients are numbered 1 to 25. Lesions are divided into two groups of left side lesions (marked with letter L) and right side lesions (marked with letter R). The fact that each number (patient) uses which drug on which side ( left side lesions (L) or right side lesions (R) ), is randomized using Block Randomization method. In fact, each patient's lesions are considered the statistical society, so randomization has taken place within each individual. 3 Actinic Keratosis. Intervention 1: Intervention group: Patients suffering Actinic Keratosis attending Razi dermatology hospital who are at least 18 years old and have a minimum number of 8 lesions (4 on each side, at least) on parts of skin that are exposed to the sun, will be recognized. A group of 25 people is chosen from among these patients. The chosen patients are explained about the medicine, the manner of using the medicine, probable side effects, mandatory use of sun screen and the importance of signing the letter of satisfaction. KOH 5% (Produced and packed in Razi hospital's laboratory of compounding drugs) and Fluorouracil 5% cream (This medicine is available in pharmacies under commercial name of Efudix in 20-gram tubes) are handed to the patients. Patients will be using the two medicines simultaneously for 4 weeks. Patients are taught to use KOH 5% for one half of the lesions and Fluorouracil 5% cream for the other half. Intervention 2: Control group: Patients suffering Actinic Keratosis attending Razi dermatology hospital who are at least 18 years old and have a minimum number of 8 lesions (4 on each side, at least) on parts of skin that are exposed to the sun, will be recognized. A group of 25 people is chosen from among these patients. The chosen patients are explained about the medicine, the manner of using the medicine, probable side effects, mandatory use of sun screen and the importance of signing the letter of satisfaction. KOH 5% (Produced and packed in Razi hospital's laboratory of compounding drugs) and Fluorouracil 5% cream (This medicine is available in pharmacies under commercial name of Efudix in 20-gram tubes) are handed to the patients. Patients will be using the two medicines simultaneously for 4 weeks. Patients are taught to use KOH 5% for one half of the lesions and Fluorouracil 5% cream for the other half. Yes - There is a plan to make this available What will be shared: All data are shareable, except for patients' pictures, after anonymizing the patients. When: All data are shareable 6 months after publishing the results, except for the patients' pictures, after anonymizing the patients. To whom: Researchers working in universities or science institutions or people working in industrial areas, can receive the data or other documents on the study. Conditions: The data or the other documents on the research, except for patients' pictures, can be used for systematic review or any other purpose provided having legal permission from the owners of the study. Where to obtain: 1: Dr. Hamidreza Mahmoudi E-mail address: hr_mahmoody@yahoo.com Mobile-phone number: 00989122612946 Razi hospital 2: Dr. Ali Salehi Farid E-mail address: ali.salehi.farid@gmail.com Mobile-phone number: 00989123711774 How to obtain: Using the data or documents is possible after one month, provided having the legal permission of the owners of the study, by one of the authorized people. Comments:
public Hamidreza Mahmoudi
Razi Dermatology Hospital, Razi Dead-end, Vahdat Eslami Sq., Vahdat Eslami St.
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5563 0174 hr_mahmoody@yahoo.com Tehran University of Medical Sciences scientific Hamidreza Mahmoudi
Razi Dermatology Hospital, Razi Dead-end, Vahdat Eslami Sq., Vahdat Eslami St.
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5563 0174 hr_mahmoody@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients suffering Actinic Keratosis attending Razi dermotology hospital Having at least 18 years of age Having a minimum number of 8 lesions( 4 on each side, at least) on parts of skin that are exposed to the sun. 18 years no limit Both Pregnant women People with a history of allergy to any of the drugs under study. L57.0 Actinic keratosis Treatment - Drugs Treatment - Drugs Intervention group: Patients suffering Actinic Keratosis attending Razi dermatology hospital who are at least 18 years old and have a minimum number of 8 lesions (4 on each side, at least) on parts of skin that are exposed to the sun, will be recognized. A group of 25 people is chosen from among these patients. The chosen patients are explained about the medicine, the manner of using the medicine, probable side effects, mandatory use of sun screen and the importance of signing the letter of satisfaction. KOH 5% (Produced and packed in Razi hospital's laboratory of compounding drugs) and Fluorouracil 5% cream (This medicine is available in pharmacies under commercial name of Efudix in 20-gram tubes) are handed to the patients. Patients will be using the two medicines simultaneously for 4 weeks. Patients are taught to use KOH 5% for one half of the lesions and Fluorouracil 5% cream for the other half. Control group: Patients suffering Actinic Keratosis attending Razi dermatology hospital who are at least 18 years old and have a minimum number of 8 lesions (4 on each side, at least) on parts of skin that are exposed to the sun, will be recognized. A group of 25 people is chosen from among these patients. The chosen patients are explained about the medicine, the manner of using the medicine, probable side effects, mandatory use of sun screen and the importance of signing the letter of satisfaction. KOH 5% (Produced and packed in Razi hospital's laboratory of compounding drugs) and Fluorouracil 5% cream (This medicine is available in pharmacies under commercial name of Efudix in 20-gram tubes) are handed to the patients. Patients will be using the two medicines simultaneously for 4 weeks. Patients are taught to use KOH 5% for one half of the lesions and Fluorouracil 5% cream for the other half. Smoothing of Actinic Keratosis's lesions' roughness. Timepoint: At the beginning of the study (Before the intervention begins) and 14, 28, 60 and 90 days after starting the use of KOH 5% solution and Fluorouracil cream. Method of measurement: Clinical diagnosis by dermatologist. The improvement of dermoscopic features of Pseudo-network pattern's lesions. Timepoint: At the beginning of the study (before the intervention begins) and 14, 28, 60 and 90 days after starting the treatment using KOH 5% solution and Fluorouracil cream. Method of measurement: Analyzing the photographed dermoscopic discoveries using a FotoFinder by two dermatology professors. The improvement of dermoscopic feature of Yellow scales' lesions. Timepoint: At the beginning of the study (before the intervention begins) and 14, 28, 60 and 90 days after starting the treatment using KOH 5% solution and Fluorouracil cream. Method of measurement: Analyzing the photographed dermoscopic discoveries using a FotoFinder by two dermatology professors. The improvement of dermoscopic feature of White scales' lesions. Timepoint: At the beginning of the study (before the intervention begins) and 14, 28, 60 and 90 days after starting the treatment using KOH 5% solution and Fluorouracil cream. Method of measurement: Analyzing the photographed dermoscopic discoveries using a FotoFinder by two dermatology professors. The improvement of dermoscopic feature of Linear-Wavy Vessels' lesions. Timepoint: At the beginning of the study (before the intervention begins) and 14, 28, 60 and 90 days after starting the treatment using KOH 5% solution and Fluorouracil cream. Method of measurement: Analyzing the photographed dermoscopic discoveries using a FotoFinder by two dermatology professors. The improvement of dermoscopic feature of Pigmented Dots' lesions. Timepoint: At the beginning of the study (before the intervention begins) and 14, 28, 60 and 90 days after starting the treatment using KOH 5% solution and Fluorouracil cream. Method of measurement: Analyzing the photographed dermoscopic discoveries using a FotoFinder by two dermatology professors. Tehran University of Medical Sciences Approved 2018-06-20 Ethics committee of Tehran University of Medical Sciences 13th ّFlr., Block A, Central HًQs of the Ministry of Health & Medical Education, Simaye_Iran St., Qods Town Tehran Tehran Iran (Islamic Republic of)