Comparison of the efficacy of ivermectin 1% cream and ketoconazole 2% cream in treatment of facial seborrheic dermatitis

Comparison of the efficacy of ivermectin 1% cream and ketoconazole 2% cream in the treatment of facial seborrheic dermatitis

Phase 3, parallel group, clinical trial, with consecutive sampling, including 40 patients, double blinded, computerized randomized with permuted blocks

The study is conducted in the dermatology clinic of Shiraz University of Medical Sciences. Group 1 will apply ivermectin 1% cream once overnight and cold cream twice daily on the face. Group two will apply ketoconazole 2% cream twice daily and cold cream once overnight on face. The patients are assessed at the beginning of treatment, first month and 2nd month by dermacatch and camera photography. The patients and outcome assessor are blinded to the type of treatment.

Inclusion criteria: Older than 18 years of age patients with severe facial seborrheic dermatitis Exclusion criteria: Using antibiotics or immunomodulatory drugs since one month before beginning of the research Using any topical drugs that can affect seborrheic dermatitis since two weeks before beginning of the research Using any oral drugs that can affect seborrheic dermatitis since one month before beginning of the research Human immunodeficiency virus infection Parkinson's disease Pregnancy Lactation sensitivity to the research drugs

Intervention group: Ivermectin 2% cream (Ajanta, Gujrat, India) is applied once overnight and cold cream twice daily on the face. Control group: Ketoconazole 2% cream (Najo, Tehran, Iran) is applied twice daily and cold cream once overnight on the face.

Determination of seborrheic dermatitis area severity index (SEDASI) score

Randomization is performed by random allocation software and participants are randomly allocated in the intervention or control group. Randomization of 40 participants in the software is performed by randomization blocks size 4 with random ratio of 1:1. The output of the software is a table that shows the number of each participant is allocated in the intervention or control group. The medications are in the similar tubes labeled by numbers of the patients.

The problem of discrepancy of numbers of daily application of the two under investigation-creams (ketoconazole cream twice daily and ivermectin cream once overnight), was solved by adding cold cream (non-effective on seborrheic dermatitis), once overnight in ketoconazole group and twice daily in ivermectin group. All drugs are packed in similar containers and have similar color, smell, and texture; and, the containers allocated to each patient are labelled with the same patients of patient recruitment number. Care provider and investigator that deliver the creams are not involved in the outcome assessment. The outcome assessor is not aware of the type of drugs in each patient. Due to similarity of the drugs and the instructions, the patients are also unaware of the type of used drugs. Therefore the research will be double-blinded.