Methotrexate Versus Triamcinilone Acetonide in Treatment of Recalcitrant Alopecia Areata

Not Applicable

Not yet recruiting

• Conditions: Alopecia Areata
• Interventions: Drug: Methotrexate; Drug: Triamcinolone Acetonide

• Registration Number: NCT06088147
• Lead Sponsor: Al-Azhar University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-25
• Study First Submitted QC: 2023-10-11
• Study First Posted: 2023-10-18
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-13
• Study Start: 2023-12
• Primary Completion: 2024-03
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1= Methotrexate	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.
Group2=Triamcinilone	Triamcinolone Acetonide	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.

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of methotrexate with microneedling versus triamcinolone with microneedling in treatment of recalcitrant alopecia areata.	6 months	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).

Trial Locations

Locations (1)

Al-Azhar University; 🇪🇬 Assiut, Egypt