Formulation and standardization of topical product of Nigella sativa L. and study on its effects in acne vulgaris, a randomized double-blind clinical study

Preparation of standardized topical product of Nigella sativa and study on its efficacy on the patients with acne vulgaris

Randomized double-blind placebo clinical trial

56 patients with mild to moderate acne vulgaris will be selected and written informed consent will be obtained, 28patients receive semi-solid preparations of Nigella sativa, and 28patients receive semi-solid preparations of placebo, twice daily for 60 days. It should be noted that both groups of patients receive oral doxycycline as gold standard. To randomly assign the patients to two groups of treatment and placebo by a third person and using a computer program with simple randomization method, the random sample number is generated and each patient will be assigned a number. Even numbers will be allocated to treatment with a semi-solid product from Nigella sativa and odd numbers to placebo. Letter "A" is assigned to the even number and the test drug, and letter "B" is assigned to the odd number and placebo. Patients and the person who provides the drug to patients will be blinded to the drug content.

-Patients between14–35 years and both genders -Mild to moderate acne as defined by the Investigator’s Global Assessment (IGA) scale -Enrolled female participants should have a negative pregnancy test

28 patients receive semi-solid preparations of Nigella sativa, and 28 patients receive semi-solid preparations of placebo, twice daily for 60 days. It should be noted that both groups of patients receive oral doxycycline as gold standard

Improve at least one grade and a maximum of 2 grades in Investigator’s global assessment grading for acne vulgaris

To randomly assign patients to two groups of treatment and placebo by a third person and using a computer program with simple randomization method, the random sample number is generated and each patient will be assigned a number. Even numbers will be allocated to treatment with a semi-solid product, from Nigella sativa and odd numbers to placebo.

Even numbers will be allocated to treatment with a semi-solid product from Nigella sativa and odd numbers to placebo. Letter "A" is assigned to the even number and the test drug, and letter "B" is assigned to the odd number and placebo. Patients and the person who provides the drug to patients will be blinded to the drug content.

The documentation including the primary and secondary outcomes of patients that will be available

From the start of the clinical study to one year after the completion of the clinical study

If another researcher wants to perform a clinical study in this field and needs our information to do the study, the information will be provided with confidentiality. - If patients have side effects, and their doctors need the treatment information. -If a health authority's health policy requires our study information, then the information is provided with confidentiality.

If the applicant is authenticated, his request will be discussed with other researchers involved in the study, and the result will be informed to him.

Samaneh Soleymani S_soleymani@razi.tums.ac.ir 0098 21 66976527

At first, the applicants must send their request to the correspond author of the study, whose email address is on the IRCT site, and after verifying the applicant's identity, including one of the upon items, the correspond author requests information of the researchers who are present in the study and is sent to applicants. This period, after the applicant's authentication, will take about two weeks.