]>
IRCT20210222050452N1 IRCT 2021-07-15 Shiraz University of Medical Sciences Comparison of the efficacy of ivermectin cream and ketoconazole cream in treatment of facial seborrheic dermatitis Comparison of the efficacy of ivermectin 1% cream and ketoconazole 2% cream in treatment of facial seborrheic dermatitis 2021-05-21 anticipated 40 Complete https://irct.ir/trial/55546 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Facial seborrheic dermatitis. Intervention 1: Intervention group: Ivermectin 2% cream (Ajanta, Gujrat, India) is applied once overnight and cold cream twice daily on the face. Intervention 2: Control group: Ketoconazole 2% cream (Najo, Tehran, Iran) is applied twice daily and cold cream once overnight on the face. 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 no more information
public Mozhdeh Sepaskhah
Dermatology clinic, Faghihi hospital, Zand St.
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3484 6316 sepaskhah@sums.ac.ir Shiraz University of Medical Sciences scientific Mozhdeh Sepaskhah
Dermatology clinic, Faghihi hospital, Zand St.
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3484 6316 sepaskhah@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients more than 18 years old Clinical diagnosis of seborrheic dermatitis (erythematous plaques with greasy and yellowish scales on nose, nasolabial fold, forehead, frown lines, cheek and chin) 18 years no limit Both ُSevere facial seborrheic dermatitis 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 study Using any oral drugs that can affect seborrheic dermatitis since one month before beginning of the research Human immunodeficiency virus infection Pregnancy Sensitivity to the research drugs constituents Parkinson'sdisease Lactation L21.9 Seborrheic dermatitis, unspecified Treatment - Drugs Treatment - 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 and severity index (SEDASI) score. Timepoint: Before intervention and 1 and 2 months after starting intervention. Method of measurement: seborrheic dermatitis area and severity index (SEDASI) score formula. Skin erythema index. Timepoint: before intervention and 1 and 2 months after starting intervention. Method of measurement: Dermacatch instrument. Pruritus severity. Timepoint: before intervention and 1 and 2 months after starting intervention. Method of measurement: ItchyQuant itch illustrated numerical rating scale. Quality of life. Timepoint: before intervention and 2 months after starting intervention. Method of measurement: Dermatology Life Quality index questionnaire Persian version. Shiraz University of Medical Sciences Approved 2021-02-14 Ethics committee of Shiraz University of Medical Sciences Shiraz University of MedicalSscience, zand Ave. Shiraz Fars Iran (Islamic Republic of)