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IRCT20251010067571N1 IRCT 2025-10-18 Kerman University of Medical Sciences Efficacy of Treatment with 2% Tofacitinib Niosomal Lotion Compared to 0.01% Clobetasol Lotion Comparative Study between Efficacy of Tofacitinib Niosomal 2% Lotion versus Clobetasol 0.01% Lotion in Alopecia Areata 2025-10-16 anticipated 40 Complete https://irct.ir/trial/86748 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. N/A Alopecia areata. Intervention 1: Intervention group: The first Group was Treated with 2% Tofacitinib Niosomal Lotion. Intervention 2: Intervention group: The second Group was Treated with 0.01% Clobetasol Lotion. Yes - There is a plan to make this available What will be shared: Data on the Main Outcomes of the Research after the Completion of Research Work Can be Published. When: Starting Access to the Data above is Immediately after Publishing the Results. To whom: Researchers in Academia and Scientific Institute are Able to Access Research Data. Conditions: In Case of Supplementary Research, Using Data is Permitted. Where to obtain: The Applicant Can Contact the Researcher to Receive Information Via Email. How to obtain: After Submitting a Written Request from the Applicant, The Data Will Be Provided to Him/Her as soon as Possible. Comments:
public Banafshe Farzadfard
Afzalipour Hospital, Emam Khomeini Blvd.
Kerman Iran (Islamic Republic of) 7616913355 +98 34 3132 8328 banafshefrzd@gmail.com Kerman University of Medical Sciences scientific Banafshe Farzadfard
Afzalipour Hospital, Emam Khomeini Blvd.
Kerman Iran (Islamic Republic of) 7616913355 +98 34 3132 8328 banafshefrzd@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) 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 4 years no limit Both 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 Cytopenia (Leukocytes > 3 × 10^9, Lymphocytes > 0.8 × 10^9, Neutrophils < Lower Limit of Normal Range, Hemoglobin < 10 g/dl, Platelets < 100 × 10^9) L63 Alopecia areata Treatment - Drugs Treatment - Drugs Intervention group: The first Group was Treated with 2% Tofacitinib Niosomal Lotion Intervention group: The second Group was Treated with 0.01% Clobetasol Lotion Hair Loss Treatment. Timepoint: 12 Weeks. Method of measurement: Measuring the Percentage of Hair Loss with SALT Score, Regrowth Rate. Kerman University of Medical Sciences Approved 2025-09-27 Research Ethics Committees of Afzalipour Hospital- Kerman University of Medical Sciences Afzalipour Hospital, Emam Khomeini Blvd. Kerman Kerman Iran (Islamic Republic of)