Comparative of the effect of oral isotretinoin and desloratadine with oral isotretinoin in the treatment of moderate to severe acne vulgaris patients

Determining and comparing the effect of using oral isotretinoin and desloratadine with oral isotretinoin in the treatment of moderate to severe acne vulgaris.

A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3, on 70 patients.

The current research is a randomized clinical trial. whose statistical population consists of patients diagnosed with acne vulgaris who referred to the skin clinic of Sinai Hospital in Hamedan in the years 1401 to 1402. Patients who met the conditions for entering the study will be interviewed after completing the consent form and all patient information such as age, gender, acne severity score, number of lesions and type of skin lesions will be recorded in the checklist. Patients will be randomly classified into two treatment groups in such a way that in terms of disease severity, age and gender are equally distributed in both groups. In order to avoid bias in this study, the researcher and the patient do not know the type of drug assigned and the study is conducted in a double-blind manner.

Criteria for entering the study: People with moderate to severe acne Exclusion criteria: Age less than 18 years, pregnant and lactating women or women who plan to become pregnant in the near future (due to the teratogenicity of isotretinoin), people with systemic diseases

the first group (A): treatment with isotretinoin capsule 20 mg once daily after lunch and desloratadine 10 mg tablet at night before going to sleep for 12 weeks. The second group (B): 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

Due to the shortage of Loratadine drug in the pharmaceutical market of the country at beginning of the trial, with the coordination of the Faculty of Medicine and the Ethics Committee, we changed the drug to Desloratadine, which was available , therefore each field that contains the word Loratadine to Desloratadine will be updated.

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.

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.