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IRCT20181005041243N1 IRCT 2022-09-16 Tehran University of Medical Sciences Effect of spironolactone and erythromycin solution in treatment of acne Efficacy and safety of spironolactone 2% versus erythromycin 4% in treating patients with acne 2022-11-10 anticipated 90 Complete https://irct.ir/trial/65851 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individual blocks will be created without stratified randomization by statistical software. And another person (rather than the doctor-researcher-patient) would do the randomization. Accordingly, patients will receive each treatment based on the randomized sequence. Block sizes: 6 Actual list length: 90 block identifier, block size, sequence within block, treatment 1, 6, 1, Group B 1, 6, 2, Group A 1, 6, 3, Group C 1, 6, 4, Group A 1, 6, 5, Group C 1, 6, 6, Group B 2, 6, 1, Group B 2, 6, 2, Group A 2, 6, 3, Group C 2, 6, 4, Group C 2, 6, 5, Group B 2, 6, 6, Group A 3, 6, 1, Group B 3, 6, 2, Group C 3, 6, 3, Group C 3, 6, 4, Group A 3, 6, 5, Group B 3, 6, 6, Group A 4, 6, 1, Group A 4, 6, 2, Group C 4, 6, 3, Group A 4, 6, 4, Group B 4, 6, 5, Group C 4, 6, 6, Group B 5, 6, 1, Group C 5, 6, 2, Group C 5, 6, 3, Group B 5, 6, 4, Group B 5, 6, 5, Group A 5, 6, 6, Group A 6, 6, 1, Group A 6, 6, 2, Group C 6, 6, 3, Group C 6, 6, 4, Group B 6, 6, 5, Group A 6, 6, 6, Group B 7, 6, 1, Group C 7, 6, 2, Group A 7, 6, 3, Group A 7, 6, 4, Group B 7, 6, 5, Group C 7, 6, 6, Group B 8, 6, 1, Group A 8, 6, 2, Group A 8, 6, 3, Group C 8, 6, 4, Group B 8, 6, 5, Group B 8, 6, 6, Group C 9, 6, 1, Group B 9, 6, 2, Group C 9, 6, 3, Group A 9, 6, 4, Group A 9, 6, 5, Group B 9, 6, 6, Group C 10, 6, 1, Group A 10, 6, 2, Group A 10, 6, 3, Group B 10, 6, 4, Group C 10, 6, 5, Group C 10, 6, 6, Group B 11, 6, 1, Group A 11, 6, 2, Group B 11, 6, 3, Group C 11, 6, 4, Group A 11, 6, 5, Group B 11, 6, 6, Group C 12, 6, 1, Group A 12, 6, 2, Group C 12, 6, 3, Group A 12, 6, 4, Group B 12, 6, 5, Group B 12, 6, 6, Group C 13, 6, 1, Group A 13, 6, 2, Group B 13, 6, 3, Group A 13, 6, 4, Group C 13, 6, 5, Group B 13, 6, 6, Group C 14, 6, 1, Group B 14, 6, 2, Group B 14, 6, 3, Group A 14, 6, 4, Group C 14, 6, 5, Group A 14, 6, 6, Group C 15, 6, 1, Group C 15, 6, 2, Group B 15, 6, 3, Group A 15, 6, 4, Group B 15, 6, 5, Group C 15, 6, 6, Group A, Blinding description: The container containing the medicines will be without a drug name label and all the containers will be similar and indistinguishable. Another person out of the study will distribute the desired medicine to the patients based on the randomization sequence. Therefore, the physician, the outcome assessor, and the analyzer will remain unaware of the drug's content. According to the mentioned points, this study will be double-blind. 2-3 Acne. Intervention 1: Intervention group 1: spironolactone 2% solution. Intervention 2: Intervention group 2: erythromycin 4% solution. Intervention 3: Intervention group 3: spironolactone 2% solution شدی erythromycin 4% solution. Yes - There is a plan to make this available What will be shared: The data file information of the participants - study protocol - statistical analysis plan - informed consent form will be published after de-identification. When: The access period starts 6 months after the results are published To whom: Receiving data will be available for researchers working in academic and scientific institutions or people who are also engaged in industry Conditions: In order to conduct scientific studies Where to obtain: Dr. Nika Kianfar nika_kianfar@yahoo.com How to obtain: After sending the request by providing a logical reason, the data will be sent to the person within 2 weeks. Comments:
public Nika Kianfar
Vahdate eslami St.
Tehran Iran (Islamic Republic of) ۱۱۹۹۶۶۳۹۱۱ +98 21 5563 0553 nika_kianfar@yahoo.com Tehran University of Medical Sciences scientific Nika Kianfar
Vahdate eslami St.
Tehran Iran (Islamic Republic of) ۱۱۹۹۶۶۳۹۱۱ +98 21 5563 0553 nika_kianfar@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Aged 18-40 Acne diagnosis by a dermatologist 18 years 40 years Both Pregnancy or breastfeeding during the intervention history of internal diseases, including endocrine diseases causing acne alteration in diet and lifestyle during the study having consumed systemic therapy for acne in the last 4 weeks having consumed oral antibiotics in the last 3 months having consumed topical therapy for acne in the last 2 weeks having consumed isotretinoin, undertaken laser, and peeling in the last 6 months Photosensitivity severe or nodularis acne polycystic ovary syndrome L70 Acne Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: spironolactone 2% solution Intervention group 2: erythromycin 4% solution Intervention group 3: spironolactone 2% solution شدی erythromycin 4% solution ََAcne severity index. Timepoint: At the beginning of the study (before the start of the intervention) and 6 and 12 weeks after the start of trial. Method of measurement: Acne severity index (ASI) formula. Patients' satisfaction with acne recovery. Timepoint: At the beginning of the study (before the start of the intervention) and 6 and 12 weeks after the start of trial. Method of measurement: Visual Analogue Scale. Tehran University of Medical Sciences Approved 2022-09-10 Ethics committee of Tehran University of Medical Sciences Vahdate-Eslami Square Tehran Tehran Iran (Islamic Republic of)