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IRCT20211010052723N1 IRCT 2021-11-18 Esfahan University of Medical Sciences Evaluation of the effect of desloratadine in the treatment of acne Comparison of the effect of oral isotretinoin with isotretinoin and des loratadine in the treatment of moderate and severe acne vulgaris 2021-11-21 anticipated 60 Complete https://irct.ir/trial/59272 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: The photograph will be evaluated by two non-executors dermatologists. 3 Acne vulgaris. Intervention 1: Intervention group: Patients undergoing standard treatment for moderate to severe acne, including isotretinoin capsule (PHARMATHEN ACNOTREN) 20mg daily and clindamycin 1% solution (manufactured by Pak Drug factory) daily Patients with severe acne are also given azithromycin 250 mg by FATAK CHEMIE PARS daily for one month and receive 5 mg of desloratadine (neotadine produced by Abaidi factory) daily. Patients with severe and moderate disease severity are divided into two equal groups. Patients are treated for six months. Intervention 2: Control group: Patients undergoing standard treatment for moderate to severe acne, including isotretinoin capsule (PHARMATHEN ACNOTREN) 20mg daily and clindamycin 1% solution (manufactured by Pak Drug factory) daily Patients with severe acne are also given azithromycin 250 mg by FATAK CHEMIE PARS daily for one month. Patients with severe and moderate disease severity are divided into two equal groups. Patients are treated for six months. Yes - There is a plan to make this available What will be shared: At the end of the study, study protocol, statistical analysis and clinical study report,the informed consent form, the codes used in the data analysis and the data dictionary can be shared with other researchers. When: Access period starts one month after the results are published To whom: Data will be available to researchers working in academic and scientific centers Conditions: Researchers can use the findings and data of this study in their research by submitting a document that proves their employment in scientific and academic centers. Where to obtain: Researchers can receive study data via sending an E-mail to researcher E-mail:Aabedini.ma@gmail.com phone number: 09128021807 Dr Mahya Abedini address: , Behdari lashgar Ave, Artesh Blv, Isfahan, Iran How to obtain: Researchers can send an email to the address to indicate the type of data they need, and after reviewing their request, the information will be sent to them via email. Comments:
public Mahya Abedini
No 58, Madanian Ave, Behdari lashgar St, Artesh Blvr
Isfahan Iran (Islamic Republic of) 8174755636 +98 31 3621 8308 Aabedini.ma@gmail.com Esfahan University of Medical Sciences scientific Ali Asilian
Skin research center, sedigheh there hospital,khorram St, Jomhouri Sq
Isfahan Iran (Islamic Republic of) 9819181876 +98 31 3335 9090 Aabedini.ma@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patient consent to participate in the study Age over 15 years No history of allergy to retinoid compounds Do not take oral medications to treat acne for the past 2 months 15 years no limit Both liver or kidney disease and dyslipidemia pregnancy or desire to get pregnant breastfeeding L70.0 Acne vulgaris Treatment - Drugs Treatment - Drugs Intervention group: Patients undergoing standard treatment for moderate to severe acne, including isotretinoin capsule (PHARMATHEN ACNOTREN) 20mg daily and clindamycin 1% solution (manufactured by Pak Drug factory) daily Patients with severe acne are also given azithromycin 250 mg by FATAK CHEMIE PARS daily for one month and receive 5 mg of desloratadine (neotadine produced by Abaidi factory) daily. Patients with severe and moderate disease severity are divided into two equal groups. Patients are treated for six months. Control group: Patients undergoing standard treatment for moderate to severe acne, including isotretinoin capsule (PHARMATHEN ACNOTREN) 20mg daily and clindamycin 1% solution (manufactured by Pak Drug factory) daily Patients with severe acne are also given azithromycin 250 mg by FATAK CHEMIE PARS daily for one month. Patients with severe and moderate disease severity are divided into two equal groups. Patients are treated for six months. Acne Score with GAGS (Global Acne Grading System). Timepoint: Evaluation of acne lesions before receiving the drug and at weeks 8, 16 and 24. Method of measurement: In the Global Acne Grading System 19 to 30 are considered moderate, 31-38 severe and above 38 very severe. Evaluation of the side effects of isotretinoin [dry skin, lips (Mild, moderate and severe), dry eyes, nosebleeds, and hair loss]. Timepoint: at weeks 8, 16 and 24. Method of measurement: Asking the patients. Esfahan University of Medical Sciences Approved 2021-10-03 Ethics Committee of Isfahan University of Medical Sciences No. 58, Shania Madanian Ave, Behdari Lashgar Street, A rtesh Blvd., Isfahan Isfahan Isfehan Iran (Islamic Republic of)