Methotrexate Versus Triamcinilone Acetonide in Treatment of Recalcitrant Alopecia Areata

Methotrexate With Microneedling Versus Triamcinilone Acetonide With Microneedling in Treatment of Recalcitrant Alopecia Areata

Alopecia areata is the second most common cause of hair loss following androgenic alopecia.

It is affecting 2% of global population with an increasing prevalence. Briefly, it is a chronic, immunomediated disease characterized by acute onset of non-scarring hair loss ranging from small circumscribed patchy areas on the scalp to complete scalp and body hair loss. Until recently our understanding of the pathophysiology of alopecia areata is scarce, despite being so common.

Methotrexate is an immunosuppressant drug that has been widely used for a range of inflammatory and immune-mediated skin disorders.

Methotrexate has been recently proven to inhibit Jak/STAT Pathway. Triamcinolone acetonide as another type of treatment of alopecia areata either intralesionally or topically remains the first line of treatment.

Study Overview

• Status: Not yet recruiting
• Conditions: Alopecia Areata
• Intervention / Treatment: Drug: Methotrexate; Drug: Triamcinolone Acetonide

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Athar Fathy Abodief; Phone Number: 01030055632; Email: atharfathy.2344@azhar.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt
    • Al-Azhar University
    • Contact: Athar Fathy Abodief; Phone Number: 01030055632

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age groups: > 12 years old.
• Sex: both sexes.
• Co-operative Patients.
• Recalcitrant or resistant cases to treatment (meaning that all patients had received various modalities of treatment in the past with poor/partial response or relapse after discontinuing therapy.

Exclusion Criteria:

• Patients <12 years.
• Pregnant and lactating women.
• Patients with any underlying Systemic disorders.
• Patients with HBV or HCV.
• Patient with active infection of T.B.
• Patients with bone marrow suppression (leukopenia, thrombocytopenia)
• Patients who had received any other modalities of treatment in last 3-6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1= Methotrexate; After microneedling, we will apply methotrexate topically (25 mg/ml) on half of the scalp at a dose of 0.02ml/cm2 with a maximum of 0.1-0.2 ml (2,5-5 mg) and rub it gently. The patient will take a session every 2 weeks for 12 weeks, on the same patient on the other patch or half of the scalp according to the pattern.	Drug: Methotrexate; A standard derma pen 12 pins with of 0,5 mm depth was used, dermapen as a tool of infusion of our treatments works in a few ways to target hair loss, firstly by breaking down the scar tissue that covers or compromises the hair follicles which are not growing, stimulating new hair growth and also by enhancing infusion of mesotherapy ingredients to increase hair follicle size and therefore hair volume ,here we will use it by stamping technique, the procedure was practically painless and therefore no local anesthesia was used, however For those who will not want to tolerate pain, topical anesthesia with 2% lignocaine, under occlusion will applied, the patients will be followed up for 6 months after full course of treatment. Then we will apply methotrexate topically (25 mg/ml) on half of the scalp at a dose of 0.02ml/cm2
Experimental: Group2=Triamcinilone; we will use Triamcinolone acetonide 40 mg/1ml after microneedking at dose 5mg/ml concentration;1/8/ 1:7 dilution session every 3 weeks for 12 weeks. then after 12 weeks of treatment we will follow up our patients after discontinuing therapy for other 12 weeks and evaluate.	Drug: Triamcinolone Acetonide; A standard derma pen 12 pins with of 0,5 mm depth was used, will use it by stamping technique, the procedure was practically painless and therefore no local anesthesia was used, however For those who will not want to tolerate pain, topical anesthesia with 2% lignocaine, under occlusion will applied, the patients will be followed up for 6 months after full course of treatment. Then Triamcinolone acetonide 40 mg/1ml after microneedking at dose 5mg/ml concentration;1/8/ 1:7 dilution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the efficacy of methotrexate with microneedling versus triamcinolone with microneedling in treatment of recalcitrant alopecia areata.	Mcdonald Hull and Norris regrowth scale by trichoscope (Time frame 6 months). Grade 1: Regrowth of vellus hair, Grade 2: Regrowth of sparse pigmented terminal hair (<50% increment in % SALT score according to NAAF guideline), Grade 3: regrowth of terminal hair with patches of alopecia (50-75% increase in % SALT score), Grade 4: regrowth of terminal hair on the whole alopecia patch (> 75% increase in% SALT score).	6 months

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: August 25, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Methotrexate; Triamcinolone; Alopecia areata; microneedling
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-Inflammatory Agents; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Triamcinolone; Methotrexate; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: MSc/AZ.AST/DVA021/6/215/1/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No