Comparison of the Effectiveness of safflower honey-based topical product with tacrolimus on improvement of symptoms (whiteness size and color) in vitiligo patients

1- Determining and comparing the size of skin spots in vitiligo patients before and after the intervention in two groups receiving safflower honey-based product and tacrolimus. 2- Determining and comparing the color of skin spots in vitiligo patients before and after the intervention in two groups receiving safflower honey-based product and tacrolimus. 3- - Evaluation and comparison of vitiligo quality of life before and after intervention in two groups receiving safflower honey-based product and tacrolimus.

A controlled, parallel-group, triple-blind, randomized, phase 3 clinical trial on 42 patients. For randomization, randomization is used by software.

The place where the study was conducted was Razi Dermatology Hospital in Tehran on patients with vitiligo and it was blinded in three ways.

Criteria for entering the project: 1- Willingness to participate and sign the informed consent form 2- Age 60-12 years 3- Having clear vitiligo lesions with the approval of a dermatologist 4- Involvement of less than 10% of the body surface Criteria for not entering the plan: 1- pregnancy or breastfeeding 2- local treatment of vitiligo in the last 4 weeks or systemic treatment or phototherapy in the last 12 weeks 3- progress in the last 6 weeks 4- serious underlying disease or use of immunosuppressive drugs

Local administration of safflower honey-based product or tacrolimus

Reducing the size and increasing the color of vitiligo lesions

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.

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.

All data is potentially shareable after de-identifying individuals

The access period starts 6 months after the results are published

Researchers working in academic, scientific and research institutions

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.

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.

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.