Investigating the effects of neem oil (Azadirachta Indica)in improving the skin manifestations of psoriasis vulgaris patients

This study aims to investigate the effects of neem oil (Azadirachta indica) on improving skin manifestations in patients with psoriasis vulgaris at Baqiyatallah Hospital.

This is a randomized controlled clinical trial (RCT) with a 1:1 allocation ratio. Randomization is performed using block randomization with block size of 4. To reduce bias, the data analyst and outcome assessor will be blinded to treatment allocation.

This study is conducted at the Skin and Beauty Clinic of Baqiyatallah Hospital in Tehran. After screening and confirming eligibility criteria, patients are enrolled after obtaining informed consent and randomly assigned to one of two groups. Outcome assessments are performed at baseline, one month, and two months after treatment initiation.

Participants are adults aged 18 years or older with mild to moderate psoriasis vulgaris. Exclusion criteria include: presence of other skin diseases, nail involvement in psoriasis, use of neuropsychiatric medications (lithium, beta-blockers, hydroxychloroquine), concurrent use of systemic or biological treatments for psoriasis, and known allergy to neem oil.

This study includes two groups: the control group (17 patients) receiving standard treatment with topical betamethasone 0.05% twice daily for 2 months, and the intervention group (17 patients) receiving standard treatment plus neem oil applied once daily topically to affected areas for 2 months.

The primary outcome is the change in Psoriasis Area and Severity Index (PASI) score before and after intervention. Secondary outcomes include changes in Dermatology Life Quality Index (DLQI) and patient satisfaction measured using a 5-point Likert scale.

In this study, block randomization using four-block permutations with random order will be employed. In this method, treatment blocks are randomly arranged forward and backward. For example, with a block length of 4 and two treatment groups, the following permutations are possible: ABBB, ABAB, ABBA, BABA, BAAB, BBAA. By randomly combining these blocks, a balanced randomization list of the two treatment groups is obtained.

To reduce bias in this clinical trial, the blinding process is designed as follows: Data Analyst Blinding: After data collection, information regarding patient grouping (intervention or control group) will be removed from the database and replaced with numerical codes. The data analyst will work exclusively with numerical codes and will remain unaware of patient treatment allocation. The code-to-treatment group mapping table will be maintained by the principal investigator, and codes will be revealed only after completion of the initial statistical analysis. Outcome Assessor Blinding: Assessment of primary outcomes (PASI index, DLQI questionnaire, and patient satisfaction) will be performed by an individual who is not involved in the randomization process or patient treatment. This assessor is not aware of the treatment group assigned to each patient, and assessments are conducted without knowledge of group allocation.

Clinical Trial Data: The collected data includes patient demographic data (age, gender), Psoriasis Area and Severity Index (PASI) scores at baseline, one month, and two months after treatment initiation, Dermatology Life Quality Index (DLQI) questionnaire, patient satisfaction scores using Likert scale (1-5), information regarding underlying diseases and family history of psoriasis. After de-identification, fully anonymized individual-level data will be available for sharing.

Access Period Start: 12 months after completion of data collection and publication of final study results. Considering the 2-month implementation period, data access is expected to be available from late 2026. Data will be accessible to applicants for 5 years after initial publication.

All researchers employed in accredited academic and research institutions, researchers in pharmaceutical and cosmeceutical industries, graduate students (Master's and PhD) in dermatology and pharmacy-related fields, and dermatology specialists may request access to anonymized data. Applicants must state a clear purpose for data use.

- Data may only be used for research purposes (including meta-analysis, secondary studies, and validation of findings). - Commercial use requires a separate agreement and prior notification. - Permitted analyses include descriptive, comparative, and statistical modeling analyses. - Applicants must properly cite the original study in any publications derived from these data. - Any re-analysis must be approved by the relevant ethics committee.

To obtain the data or documents, applicants may contact Dr. Majid Shahrati (Principal Investigator) at phone number +98-21-82483388 or by mail at: Tehran, Baqiyatallah Hospital, Faculty of Pharmacy, Clinical Research Development Unit. After registration of the clinical trial in the IRCT system, the email address and study website will also be announced through the system. Telephone contact is recommended as the first and fastest method of communication.

The request process begins with applicants submitting a written request including their research purpose, research proposal, and confidentiality agreement. The principal investigator will then review the request and announce the decision within 3 weeks (1 week for initial review and 2 weeks for final decision). If approved, a data use agreement will be sent, and after signing, the data will be provided within 1 week. Overall, the entire process from request submission to data receipt takes approximately 4-5 working weeks.