Comparison of the Efficacy and Safety of Simvastatin 2% Topical Gel with Placebo in Treatment of Acne Vulgaris Patients

The aim of this study is to compare the efficacy and safety of simvastatin 2% topical gel with placebo for acne vulgaris.

Clinical trial with control group, community based and pragmatic with a parallel group, double blinded, randomized

Patient recruitment takes place at dermatology clinic of Amir-Almomenin hospital in Tehran. During the study, all the patients are visited by dermatologist for the clinical qualification, only after obtaining a written consent from by the researcher. The demographic details and quality of life characteristics are recorded, too. The patients are taken photo of both of the sides. Each patient randomly applies a thin layer of simvastatin 2% gel on one side, and concurrently after washing hands thoroughly, applies the placebo gel on the other side of the face. In the blinding process, an independent pharmacist helps. Both gel samples are prepared in similar, separated labeled tubes. The two tubes are kept inside a sealed box, therefore, all the 30 patients are blinded by this process.

The inclusion criteria is patients with mild and moderate acne vulgaris in the global acne grading system. The exclusion criteria are pregnancy, lactation, dermatological malignancy, burning, infection, known hypersensitivity to simvastatin and receiving any topical or oral medication for acne vulgaris in the last one month.

The patients with acne vulgaris undergo treatment with simvastatin gel 2% and placebo gel for eight weeks and two times a day. Each of the gels is allocated to each side of the face based on randomization method.

A significant reduction in the inflammation of acne lesions; A remarkable decrease in the acne scores assessed by Global Acne Grading System; Improvement in quality of life of patients with acne

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.

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.

All the data potentially can be shared after being unidentifiable.

The start of the access period will be 6 months after the publication of the results.

All the data will be available to all the people.

All the data can be used by all the people with condition of mentioning the source.

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.

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.