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IRCT20221226056928N1 IRCT 2023-01-23 Shahed University Effect of safflower honey-based topical product in treatment of vitiligo Comparison of the Effectiveness of safflower honey-based topical product with tacrolimus on improvement of symptoms (whiteness size and color) in vitiligo patients 2023-05-22 anticipated 42 Complete https://irct.ir/trial/67978 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Randomization is simple and each participant is randomly assigned the main intervention treatment or the control group treatment. Randomization unit: individual. Randomization tool: statistical software and sealed envelope. A code is assigned to each sealed envelope by the software, and one of these codes is randomly assigned to each participant by the software, and the corresponding envelope containing the medicine is delivered to the patient. The person who registers the codes in the software is different from the person who delivers the envelopes, Blinding description: The patient who entered the study with informed consent does not know the type of treatment. The person who saves the assigned codes and inserts them on the envelopes has no connection with the patients. The researcher and the clinical caregiver are not aware of the contents of the envelopes. The outcome evaluator will be informed only if a serious side effect, after which the patient is excluded from the study. The data analyst and the data safety and monitoring committee will not be informed about the identity of the participants. 2-3 vitiligo. Intervention 1: Intervention group: Applying a thin layer of honey-based safflower topical product to the affected area twice a day. Intervention 2: Control group: Applying a thin layer of 0.1% tacrolimus ointment to the lesion site twice a day. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: Researchers working in academic, scientific and research institutions Conditions: It is allowed to use the data for the purpose of meta-analyses and by preserving all the rights of the creators of this data. Where to obtain: By referring to the scientific officer of the research Ms. Dr. Fatemeh Emadi at the email address fatemeh12emadi@yahoo.com and at the address of Shahid University, Fars Gulf Highway, Tehran, Tehran Province, Iran. zip code 3319118651. contact number 00982151214055. How to obtain: The applicant's request will be sent to the mentioned e-mail containing the applicant's profile, the purpose of receiving the data, and the details of the desired data, and it will be checked for compliance of the conditions and data requested with the publication conditions within a maximum of one month, and an appropriate response will be sent. Comments:
public Mohammadreza Najjarzadeh
No. 87, East 194 Ave., Tehranpars
Tehran Iran (Islamic Republic of) 1655863416 +98 21 7773 4834 dmrnajjarzadeh@gmail.com Shahed University scientific Fatemeh
Persian Gulf highway
Tehran Iran (Islamic Republic of) 3319118651 +98 21 5121 4055 fatemeh12emadi@yahoo.com Shahed University Iran (Islamic Republic of) Having clear vitiligo lesions with the dermatologist approval Involvement of less than 10% of the body surface 12 years 60 years Both pregnancy or breastfeeding local treatment of vitiligo in the last 4 weeks or systemic treatment or phototherapy in the last 12 weeks progress in the last 6 weeks serious underlying disease or use of immunosuppressive drugs L80 Vitiligo Treatment - Drugs Treatment - Drugs Intervention group: Applying a thin layer of honey-based safflower topical product to the affected area twice a day Control group: Applying a thin layer of 0.1% tacrolimus ointment to the lesion site twice a day The extent of vitiligo lesions. Timepoint: Measuring the extent of vitiligo lesions at the beginning of the study (before the start of the intervention) and 28 and 84 days after the start of using the honey-based safflower topical product. Method of measurement: Calculating the area of the lesion using transparent graded paper. Color index of vitiligo lesions. Timepoint: Measurement of the color index of vitiligo lesions at the beginning of the study (before the start of the intervention) and 28 and 84 days after the start of the use of honey-based safflower topical product. Method of measurement: Comparison of whitening rate with healthy skin, (completely white 100%; slightly colored white 90%; whiteness more than colored 75%; Whiteness and colored equal to 50%; Whiteness less than colored 75%; brief whiteness 10%; Natural skin color%0) by observation and photography. Vitiligo Area Scoring Index (VASI). Timepoint: Measurement of the Vitiligo Area Scoring Index (VASI) at the beginning of the study (before the start of the intervention) and 28 and 84 days after the start of using the honey-based safflower topical product. Method of measurement: We multiply the color index of each lesion by the percentage of involvement of each lesion compared to the whole skin of the body and add up the obtained numbers. Quality of life score in VitiQoL questionnaire. Timepoint: Fill out vitiligo quality of life questionnaire at the beginning of the study (before the start of the intervention) and 84 days after starting the use of honey-based safflower topical product. Method of measurement: Vitiligo quality of life questionnaire (VitiQoL). Shahed University Approved 2023-01-02 Ethics Committee of Shahid University Persian Gulf Freeway Tehran Tehran Iran (Islamic Republic of)