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IRCT20120215009014N493 IRCT 2023-12-12 Hamedan University of Medical Sciences Effect of topical cream containing green tea and licorise extract as add-on therapy versus control group on the improvement of mild to moderate acne Effect of topical cream containing green tea and licorise extract as add-on therapy versus control group on the improvement of mild to moderate acne: a double-blind randomized clinical trial 2023-12-26 anticipated 70 Complete https://irct.ir/trial/74260 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, random assignment of patients to the intervention and control groups will be carried out using block randomization. To achieve this, four sheets of paper will be prepared - two with the name of the intervention and two with the name of the control. These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired sample size is reached, Blinding description: Both the medications and placebos will have the same shape. Consequently, patients will remain unaware of the type of intervention they receive. Moreover, the randomization process will be conducted by a separate individual from the one who examines the patients, ensuring that the examining person remains unaware of the intervention. Therefore, the trial will be conducted as a double-blind study. 3 Acne. Intervention 1: Intervention group: Clindamycin topical solution 1% plus topical cream containing green tea extract and licorice twice a day for 8 weeks. Intervention 2: Control group: Clindamycin topical solution 1% plus base cream without green tea extract and licorice twice a day for 8 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It depends on the situation and the results of the study as well as the approval of the financial supporting organization.
public Zahra Aziz Malayeri
School of Pharmacy, Hamadan University of Medical Sciences, Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 zahra.azizmly@gmail.com Hamedan University of Medical Sciences scientific Dr. Seyed Yaser Vafaei
School of Pharmacy, Hamadan University of Medical Sciences, Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 vafaei¬¬_y@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age 12 to 70 years Mild to moderate acne for at least 6 months 12 years 70 years Both Pregnancy or breastfeeding Acne lesions with infection The presence of other skin diseases at the same time L70 Acne Treatment - Drugs Placebo Intervention group: Clindamycin topical solution 1% plus topical cream containing green tea extract and licorice twice a day for 8 weeks Control group: Clindamycin topical solution 1% plus base cream without green tea extract and licorice twice a day for 8 weeks Severity and extent of acne lesions. Timepoint: Before the intervention and in the fourth and eighth weeks after the intervention. Method of measurement: Based on the Global Acne Grading System (GAGS). Quality of life of patients. Timepoint: Before the intervention and in the fourth and eighth weeks after the intervention. Method of measurement: Using Dermatology Life Quality Index (DLQI). Hamedan University of Medical Sciences Approved 2022-12-31 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)