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IRCT20220705055374N1 IRCT 2022-07-11 Hamedan University of Medical Sciences Comparative of the effect of oral isotretinoin and desloratadine with oral isotretinoin in the treatment of moderate to severe acne vulgaris patients Comparative of the effect of oral isotretinoin and desloratadine with oral isotretinoin in the treatment of moderate to severe acne vulgaris patients 2022-08-23 anticipated 70 Complete https://irct.ir/trial/64640 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation rule: The number of samples allocated to each of the studied groups is equal, so that the intervention group includes 35 people and the control group also includes 35 people. 35 balls for the intervention group and 35 balls for the control group are drawn in a container. and then the balls are randomly removed from the container without replacement and the created sequence is recorded, Blinding description: Desloratadine tablets and placebo tablets will be prepared in the same sealed envelopes so that neither the researcher nor the patient will know the type of drug. 3 Acne vulgaris. Intervention 1: Intervention group: Treatment with isotretinoin capsule 20 mg once daily after lunch and desloratadine 10 mg tablet at night before sleep for 12 weeks. Intervention 2: Control group: Treatment with isotretinoin capsules 20 mg daily after meals and placebo tablets at night before sleep for 12 weeks. 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 more information
public Forough Eftekhari
Hamadan University of Medical Sciences, Shahid Fahmideh Blvd.,Pajoohesh square
Hamedan Iran (Islamic Republic of) ۶۵۱۷۸۳۸۷۳۶ +98 81 3131 0000 forough.eftekhari8@gmail.com Hamedan University of Medical Sciences scientific Bahareh Ebrahimi
Hamadan University of Medical Sciences, Shahid Fahmideh Blvd.,Pajoohesh square
Hamedan Iran (Islamic Republic of) 6516737157 +98 81 3131 0000 b.ebrahimi.4362@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Patient with moderate to severe acne 18 years no limit Both Age<18 years Pregnant and lactating female Systemic disease Concurrent use of other acne therapies Other dermatological condition requiring interfering treatment L70.0 Acne vulgaris Treatment - Drugs Placebo Intervention group: Treatment with isotretinoin capsule 20 mg once daily after lunch and desloratadine 10 mg tablet at night before sleep for 12 weeks. Control group: Treatment with isotretinoin capsules 20 mg daily after meals and placebo tablets at night before sleep for 12 weeks. Number of acne lesions after treatment. Timepoint: At baseline and at weeks 4, 8 and 12 after treatment. Method of measurement: Observe and record in the checklist. Hamedan University of Medical Sciences Approved 2022-06-27 Ethics committee of Hamedan University of Medical Sciences Khawaja Rashid Crossroad - Beginning of Ayatollah Kashani Blvd - University of Medical Sciences and Health Services of Hamedan Province Hamedan Hamadan Iran (Islamic Republic of)