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IRCT20221001056063N1 IRCT 2022-10-11 Shiraz University of Medical Sciences Comparison of the efficacy of rosemary lotion and ketoconazole lotion in treatment of seborrheic dermatitis Efficacy of rosemary extract lotion in the treatment of dandruff in seborrheic dermatitis in comparison with ketoconazole %2 lotion a double-blind clinical trial 2022-10-23 anticipated 42 Complete https://irct.ir/trial/66140 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not 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 42 participants in the software is performed by randomization blocks 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: 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 Scalp seborrheic dermatitis. Intervention 1: Intervention group: Rosemay lotion is applied twice daily on the scalp for two months. Intervention 2: Control group: Ketoconazole 2% lotion is applied twice daily on the scalp for two months. 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 The study has not ended
public Maryam Sadat Sadati
Dermatology clinic, Faghihi hospital, Zand St.
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3484 6316 msadati63@yahoo.com Shiraz University of Medical Sciences scientific Maryam Sadat Sadati
Dermatology clinic, Faghihi hospital, Zand St.
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3484 6316 msadati63@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients 18-60 years old clinical diagnosis of scalp seborrheic dermatitis ASFS score > 10 DLQI index > 2 18 years 60 years Both Severe seborrheic dermatitis in other areas 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 Other scalp diseases Scalp surgery in the previous month Sensitivity to the research drugs Pregnancy Lactation L21.9 Seborrheic dermatitis, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Rosemay lotion is applied twice daily on the scalp for two months. Control group: Ketoconazole 2% lotion is applied twice daily on the scalp for two months. Adherent scalp flaking score ( ASFS score ). Timepoint: Before intervention and 1 and 2 months after starting intervention. Method of measurement: Adherent scalp flaking score ( ASFS score ) formula. 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 2022-05-22 Ethics committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences, Zand Ave. Shiraz Fars Iran (Islamic Republic of)