Methotrexate Versus Triamcinilone Acetonide in Treatment of Recalcitrant Alopecia Areata

Al-Azhar University

Status: Not yet enrolling

Conditions: Alopecia Areata

Treatments: Drug: Methotrexate; Drug: Triamcinolone Acetonide

Study type: Interventional

Funder types: Other

Identifiers

NCT06088147

MSc/AZ.AST/DVA021/6/215/1/2023

Details and patient eligibility

About

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.

Enrollment: 34 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups

Group 1= Methotrexate

Active Comparator group

Description:

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.

Treatment:

Drug: Methotrexate

Group2=Triamcinilone

Experimental group

Description:

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.

Treatment:

Drug: Triamcinolone Acetonide