Comparative Study between Efficacy of Tofacitinib Niosomal 2% Lotion versus Clobetasol 0.01% Lotion in Alopecia Areata

Determining the Effectiveness of Treatment with 2% Tofacitinib Niosomal Lotion Compared to 0.01% Clobetasol Lotion in the Treatment of Patients with Alopecia Areata

The Clinical Phase of This Study Will Be Conducted as a Randomized, Double-Blind Clinical Trial on 40 Patients with Patchy Scalp Alopecia Areata at Afzalipour Hospital, Kerman in 2024. The Aim Is to Initially Evaluate the Efficacy and Safety Of 2% Tofacitinib Niosomal Lotion Compared to 0.01% Clobetasol. The Diagnosis of the Disease Will Be Made by a Dermatologist. Patients will be Divided into Two Groups Using a Block Randomization Method and Will Apply the Lotions to the Alopecia Patches Twice Daily For 12 Weeks.

This Study is a Double-Blind Clinical Trial (Analyst and Evaluator are Unaware of the Type of Treatment) on Patients with Patchy Alopecia Areata Referred to Afzalipour Hospital in Kerman in 1404.

Entry requirements: Age Equal to or Greater Than Four Years, Alopecia Areata Patchy Form (SALT ≤ 25%), Not Using Other Hair Loss Treatments in the Past Three Months, Ability and Willingness to Follow Instructions for Using Lotions, Normal Tests Include: CBC, Creatinine, Liver Tests, Thyroid Tests, Anti-Thyroperoxidase and Thyroglobulin Antibodies, and FBS Exit requirements: History of Autoimmune Diseases and Use of Biological Therapies and Immunosuppressants Within the Past 6 Months Use of Topical Corticosteroids in the Past Month at the Site Pregnancy, Breastfeeding Phototherapy within the past 3 Months Thyroid Dysfunction and Cytopenia

The First Group is Treated With 2% Tofacitinib Niosomal Lotion and the Second Group is Treated with 0.01% Clobetasol Lotion.

Hair Loss Treatment

The Unit Randomization Is Performed in A Block Method with a Block Size Of 4. For Each of the 6 Possible Cases for the Block of 4, The Numbers Are Assigned as Follows: ABBA(3), ABAB(2), AABB(1), BAAB(6), BABA(5), BBAA(4) with the Help of a Random Number Table, Numbers Between 1 And 6 Are Selected and the Treatment Allocation List Is Determined According to Each Number. To Implement the Generated Random Sequence, The Method of Concealing Coded Boxes or Cans Is Used. In This Method, The Cans are Numbered based on a Random Sequence and Inside the Boxes, The Desired Intervention (Drug) or a Sheet on Which the Random Assignment Is Written Is Provided to the Executor, Provided That the Boxes Are Completely Sealed, and the Researcher Allocates Them to the Intervention and Standard Treatment Groups Based on the Order of Patients' Arrival. Tool: Creating A Random Sequence of 4-Block Randomization Concealment Will Be Performed to Implement the Random Sequence on the Study Participants. Construction: Randomly Select the Block and Read the Letters from Right to Left. Concealment Will Be Done Using Cans That Are Numbered in a Random Sequence. The Cans Will Have the Same Weight and Shape and Will Be Prepared by an Independent Researcher.

The Study is Conducted in a Double-Blind, Randomized Manner; The Patient and the Evaluating Physician are Unaware of the Treatment Type (Tofacitinib Niosomal 2% Or Clobetasol 1%). The Drugs are Standardized in Appearance, Color, And Packaging, and Each Package Is Identified by a Confidential Random Code. The List of Codes Is Kept by the Responsible Pharmacist and Can Only Be Opened in Cases of Medical Emergency

Data on the Main Outcomes of the Research after the Completion of Research Work Can be Published.

Starting Access to the Data above is Immediately after Publishing the Results.

Researchers in Academia and Scientific Institute are Able to Access Research Data.

In Case of Supplementary Research, Using Data is Permitted.

The Applicant Can Contact the Researcher to Receive Information Via Email.

After Submitting a Written Request from the Applicant, The Data Will Be Provided to Him/Her as soon as Possible.