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IRCT20100119003106N38 IRCT 2018-07-28 Islamic Azad University, Pharmaceutical Sciences Branch Effect of Simvastatin gel in treatment of acne ADR Comparison of the Efficacy and Safety of Simvastatin 2% Topical Gel with Placebo in Treatment of Acne Vulgaris Patients 2018-07-15 anticipated 30 Complete https://irct.ir/trial/32220 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomized allocation is based on a single sequence in this study, therefore, the method used is simple randomization. The unit of randomization is individual. At first, the two tubes containing simvastatin and placebo are determined by labeling and are received by the third-party in dual packages. The third-party uses random coin tossing to determine the side of the face that each of the gels should be used. Then he allocates a code to each of the packages, notes them all down and keeps them until the end of the study. The mentioned package, on the side of which the part it should be used is written, is sealed and handed on the patients. Allocation of the mentioned package accomplishes by a random selection of one of the available codes written on the packages by the patient himself. The mentioned dual tubes are exactly the same in the case of weight and shape and so the desired allocation is concealed, Blinding description: An independent pharmacist helps us in the blinding process. Both gel sample types are prepared in similar, separated labeled tubes. A random coin tossing is used by him for randomization of gel samples to two "right" and "left" groups. The two tubes are kept inside a sealed box, therefore, the researcher, the care provider, dermatologist, and the patients are blinded by this process. Data collectors and outcome assessors are blinded until the end of the research, too. Every box has a special code. Each patient is assigned one of those allocated codes by a random selection by himself. 2-3 Acne Vulgaris. Intervention 1: Intervention group: the use of gel simvastatin 2% on half of the face twice a day for 8 weeks. Intervention 2: Control group: the use of gel placebo on half of the face twice a day for 8 weeks. Yes - There is a plan to make this available What will be shared: All the data potentially can be shared after being unidentifiable. When: The start of the access period will be 6 months after the publication of the results. To whom: All the data will be available to all the people. Conditions: All the data can be used by all the people with condition of mentioning the source. Where to obtain: Applicants can refer to the clinical department of Islamic Azad University, Pharmaceutical Sciences branch, Dr. Rajabi or contact the researcher by sending email to faezeh.teimouri2920@gmail.com or calling 09371432153. How to obtain: Applicants can apply for research information by visiting the department or by contacting the e-mail address and telephone number as well as providing information on academic studies and the purpose of requesting the information. Applicants must commit themselves to mention the source. If the request is sent six months after the publication of the research information, the researcher will send the data to the requesting party by email within a week. Comments:
public Dr. Mehdi Rajabi
Islamic Azad University, Pharmaceutical Sciences Branch, Dr. Shariati Ave., Qolhak., Yakhchal St., Yasaman Ave., Tehran Town
Tehran Iran (Islamic Republic of) 1941933111 +98 21 2264 0051 mehdirj@aol.com Islamic Azad University scientific Dr. Roghaye Jebraeili
Khaghani street, Dr. Shariati Avenue Tehran
Tehran Iran (Islamic Republic of) 1916893813 +98 21 2200 6660 mehdirj@aol.com Islamic Azad University Iran (Islamic Republic of) Patients with mild and moderate acne vulgaris no limit no limit Both Pregnant women Breastfeeding women The patients with dermatological malignancy The patients with burning The patients with infection The patients which have known hypersensitivity to simvastatin The patients which have received any topical or oral medications for acne vulgaris in the last one month L70.0 Acne vulgaris Treatment - Drugs Treatment - Drugs Intervention group: the use of gel simvastatin 2% on half of the face twice a day for 8 weeks Control group: the use of gel placebo on half of the face twice a day for 8 weeks Acne scores in the Global Acne Grading System. Timepoint: Before intervention and 2, 5 , 8 weeks after intervention. Method of measurement: The Global Acne Grading System Formula. Quality of life score. Timepoint: Before intervention and 2, 5, 8 weeks after intervention. Method of measurement: The Cardiff Acne Disability Index questionnaire. Islamic Azad University, Pharmaceutical Sciences Branch Approved 2017-01-05 Ethics committee of Islamic Azad University, Pharmaceutical Sciences Branch Islamic Azad University, Pharmaceutical Sciences Branch, Dr. Shariati Ave., Qolhak., Yakhchal St., Yasaman Ave., Tehran Town Tehran Tehran Iran (Islamic Republic of)