Methotrexate Versus Triamcinilone Acetonide in Treatment of Recalcitrant Alopecia Areata

Alopecia Areata Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06088147
• Other study ID #: MSc/AZ.AST/DVA021/6/215/1/2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: June 2024

Study information

• Verified date: November 2023
• Source: Al-Azhar University
• Contact: Athar Fathy Abodief
• Phone: 01030055632
• Email: atharfathy.2344[@]azhar.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: June 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	Al-Azhar University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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