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IRCT20111224008507N7 IRCT 2025-02-10 Mazandaran University of Medical Sciences Evaluating the effect of topical phage cocktail for the treatment of acne Clinical trial of the effect of topical phage cocktail for the treatment of acne vulgaris 2025-02-19 anticipated 100 Complete https://irct.ir/trial/81670 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, using the Random number generation plugin in excel software, a table of random numbers from 1 to 100 is prepared in a non-sequential and scattered manner, and the numbers are assigned to two intervention and control groups of 50 cases. The randomization process is performed by the methodology consultant and clinical researchers are not aware of the randomization process and will only be provided with random codes from 1 to 100, Blinding description: After selecting the samples, none of the participants will be aware of randomization and allocation to groups. Physicians will be given a table of pre-coded numbers and patients will be entered into the study in order of table numbers. Therefore, the present study will be double-blind. The phage cocktail and placebo are prepared in completely identical tubes and the pharmacist who prepares the phage cocktail and placebo labels A and B on the tubes. 3 Acne vulgaris. Intervention 1: Intervention group: In the intervention group, 1% clindamycin topical ointment with a phage cocktail gel is applied for 8 weeks. Every morning and evening, patients wash their face with non-medicated soap, then rinse and dry it thoroughly. Over an 8-week period, patients use the phage cocktail gel in the intervemtion group in the morning and evening. Clindamycin topical ointment1% is applied in the evening. The second evening medication is applied approximately 10 to 15 minutes after the first medication. Intervention 2: Control group: In the control group, 1% clindamycin topical ointment with a base placebo gel is applied for 8 weeks. Every morning and evening, patients wash their face with non-medicated soap, then rinse and dry it thoroughly. Over an 8-week period, patients use the placebo gel in the control group in the morning and evening. Clindamycin topical ointment1% is applied in the evening. The second evening medication is applied approximately 10 to 15 minutes after the first medication. Yes - There is a plan to make this available What will be shared: Part of the data is accessible When: Access period from March 2027 To whom: Physicians Conditions: Systematic review articles Where to obtain: Contact Dr. Mohammad Sadegh Rezai. E-mail: drmsrezaii@yahoo.com How to obtain: After contact, information is sent within a few days Comments:
public Mohammadsadegh Rezai
Bouali Hospital, Pasdaran Boulevard, Sari
Sari Iran (Islamic Republic of) 4815838477 +98 11 3334 2334 drmsrezaii@yahoo.com Mazandaran University of Medical Sciences scientific Mohammadsadegh Rezai
Bouali Hospital, Pasdaran Boulevard, Sari
Sari Iran (Islamic Republic of) 4815838477 +98 11 3334 2334 drmsrezaii@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Age 12 to 25 years Mild to moderate acne vulgaris 12 years 25 years Both Active cancer Immune system defect History of allergy Uncontrolled systemic disease Receiving topical anti-acne treatment 2 months before or during the study Systemic antibiotic treatment during the study Use of oral contraceptive pills (OCP) and spironolactone 30 days before or during the study History of treatment with systemic retinoids Having a skin disease that may interfere with diagnosis or evaluation L70.0 Acne vulgaris Treatment - Drugs Placebo Intervention group: In the intervention group, 1% clindamycin topical ointment with a phage cocktail gel is applied for 8 weeks. Every morning and evening, patients wash their face with non-medicated soap, then rinse and dry it thoroughly. Over an 8-week period, patients use the phage cocktail gel in the intervemtion group in the morning and evening. Clindamycin topical ointment1% is applied in the evening. The second evening medication is applied approximately 10 to 15 minutes after the first medication. Control group: In the control group, 1% clindamycin topical ointment with a base placebo gel is applied for 8 weeks. Every morning and evening, patients wash their face with non-medicated soap, then rinse and dry it thoroughly. Over an 8-week period, patients use the placebo gel in the control group in the morning and evening. Clindamycin topical ointment1% is applied in the evening. The second evening medication is applied approximately 10 to 15 minutes after the first medication. Reducing the number of skin lesions. Timepoint: First visit before treatment, second, fourth and eighth weeks. Method of measurement: Skin lesion count. Reducing the number of inflammatory skin lesions. Timepoint: First visit before treatment, second, fourth and eighth weeks. Method of measurement: Skin lesion count. Reducing the number of total skin lesions. Timepoint: First visit before treatment, second, fourth and eighth weeks. Method of measurement: Skin lesion count. Reducing the acne severity index. Timepoint: First visit before treatment, second, fourth and eighth weeks. Method of measurement: Acne severity index = papules + (2 × pustules) + (comedones /4). Side effects such as redness, itching, burning, and inflammation. Timepoint: Second, fourth and eighth weeks. Method of measurement: Asking the patient or the patient's mother. Mazandaran University of Medical Sciences Approved 2024-12-04 Ethics committee of Mazandaran University of Medical Sciences Vice chancellor for Research, Moallem square, Sari Sari Mazandaran Iran (Islamic Republic of)