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IRCT20230921059485N1 IRCT 2024-06-27 Shiraz University of Medical Sciences Evaluating the effect of topical N-acetyl cysteine in treatment of acne Comparing the efficacy of combination of doxycycline and topical N-acetyl cysteine versus doxycycline and topical benzoyl peroxide in the treatment of patients with moderate acne vulgaris 2024-06-30 anticipated 40 Complete https://irct.ir/trial/77368 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided to groups A and B using block randomization and sealed envelope online randomization software. Our colleague will put benzoyl peroxide and N-acetyl cysteine in alike boxes and the code of randomization will be put on the boxes. The codes will not be clarified until the end of research. (allocation concealment), Blinding description: The study is double-blinded. Neither The investigator nor the patients will not know the type of topical medication (benzoyl peroxide or N-acetyl cysteine). The colleague will put the drugs in alike boxes and the code of block randomization will be put on the boxes. The drugs will be given to the patients by the colleague monthly. The codes will not be clarified till the end of research and neither the investigator nor the patients will not know the type of medication till the end of research. 3 Acne. Intervention 1: Intervention group (group A): combination of doxycycline Hakim company 100 mg once daily and N-acetyl cysteine 5% gel once daily for 3 months. For preparing N-acetyl cysteine 5% gel we will use N-acetyl cysteine powder in the base of sodium carboxy methyl cellulose polymer and some excipients including solvents, moisturizers and antimicrobials will be added too. All the excipients used are allowed. Intervention 2: Control group (B): combination of doxycycline Hakim company 100 mg once daily and benzoyl peroxide 5% gel, Pars Behroozan Jam company for 3 months. Yes - There is a plan to make this available What will be shared: Parts of data will be shared. The patient's data will be kept confidential. When: Starting 3 months after publication To whom: Data will be available for people working in academic institutions or people working in businesses. Conditions: To commercialize the product and use it widely as an acne treatment. Where to obtain: please mail: neginfzd@yahoo.com How to obtain: please mail: neginfzd@yahoo.com Comments:
public Negin Fazelzadeh Haghighi
Zand Avenue
Shiraz Iran (Islamic Republic of) 7134846114-713484631 +98 71 3212 5239 neginfzd@yahoo.com Shiraz University of Medical Sciences scientific Negin Fazelzadeh Haghighi
Zand Avenue
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3212 5239 neginfzd@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) patients with moderate Acne married females who agree with taking oral contraceptive pills (OCP) during treatment 15 years 35 years Both below 15 or over 35 years old unwillingness to participate in the study inability to come regularly for follow-up visits use of herbal medicine receiving systemic anti acne therapies 1 month before the study receiving topical anti acne therapies 2 weeks before the study pregnancy and breast feeding hepatic diseases renal diseases use of nitroglycerine use of medications that have interaction with the drugs used in the study history of hypersensitivity to the medications used in the study L70.0 Acne vulgaris Treatment - Drugs Treatment - Drugs Intervention group (group A): combination of doxycycline Hakim company 100 mg once daily and N-acetyl cysteine 5% gel once daily for 3 months. For preparing N-acetyl cysteine 5% gel we will use N-acetyl cysteine powder in the base of sodium carboxy methyl cellulose polymer and some excipients including solvents, moisturizers and antimicrobials will be added too. All the excipients used are allowed. Control group (B): combination of doxycycline Hakim company 100 mg once daily and benzoyl peroxide 5% gel, Pars Behroozan Jam company for 3 months. Acne severity. Timepoint: 1 and 3 month later. Method of measurement: according to Investigator Global Assessment (IGA) score. Acne severity. Timepoint: 1 and 3 months later. Method of measurement: according to Global Acne Grading System (GAGS) score. Quality of life improvement. Timepoint: 1 and 3 months later. Method of measurement: Cardiff Acne Disability Index (CADI) quality of life questionnaire. Treatment response. Timepoint: after 3 months. Method of measurement: question the patients. Shiraz University of Medical Sciences Approved 2023-11-27 Biomedical Research Ethics Committee of Shiraz Medical School Zand Avenue, Shiraz Medical School, Building number 3, Third floor, Vice Chancellor for Research Office of Shiraz Medical School, Ethics Committee Shiraz Fars Iran (Islamic Republic of)