Methotrexate Alone vs Combination With Excimer Light in Nail Psoriasis

Nail Psoriasis Clinical Trial

Official title:

Intra-matrical Methotrexate Alone Versus Its Combination With Excimer Light in Treatment of Nail Psoriasis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06150794
• Other study ID #: ASU-MTX
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: November 2023
• Source: Assiut University
• Contact: Manar Elammary, MD
• Phone: +2010002060881
• Email: Manar.elammary24[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the efficacy of excimer laser in combination with intralesional MTX injection to intralesional MTX injection alone in treating nail psoriasis

Description:

Psoriasis is a chronic inflammatory disease affecting the skin, nails, and joints. Approximately 61% of psoriatic patients have nail involvement. This percentage can increase up to 90% in patients with psoriatic arthritis. Clinically, nail disease has many presentations depending on the location of the inflammatory process in either the matrix, the nail bed, or the periungual tissue, which results in distinct injury patterns.

Nail psoriasis can lead to impairment in the quality of life and work function due to pain, discomfort, and poor esthetic aspect. Treating nail involvement is important in improving the health outcomes and quality of life among patients with psoriasis. Nail psoriasis is a clinical diagnosis generally made in the context of existing psoriatic skin lesions. The nail psoriasis severity index (NAPSI) has recently been reported as a possible reproducible, objective, and simple tool for clinical assessment of psoriatic nail disease.

Treatment of nail psoriasis is challenging because of the anatomical properties of the nail unit that act as a barrier to active drug delivery and the naturally slow growth rate of the nail plate, which often delays noticeable clinical responses by months. Treatment options available for nail psoriasis include topical therapy, intralesional injections, and systemic and biologic agents. Poor penetration of topical therapy into the nail and surrounding tissue, adverse effects and monitoring of systemic therapies, and patient adherence to therapy make the treatment of nail psoriasis a challenge.

Few publications have been recently concerned intralesional injection of methotrexate in nail psoriasis. This therapy was documented for the first time in 2011. Intramatricial injection of methotrexate is an interesting intralesional therapy as it provides a higher concentration of the drug at the site of action, while avoiding the complications seen with triamcinolone acetonide (injection site atrophy, disappearance of the phalanx under injection, or tendon rupture) The use of excimer laser for the treatment of psoriasis was first documented in 1997. The excimer laser induces T-cell apoptosis characterized by breaks in DNA strands as well as expression of mitochondrial proteins associated with cell death.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with bilateral fingernail psoriasis will be recruited. The diagnosis will be based upon the clinical characteristics of nail psoriasis.

• Patients will be included after they have stopped any systemic therapy for at least 8 weeks.

Exclusion Criteria:

• Pregnant or lactating woman

• Patients with history of photosensitivity or keloid formation.

Related Conditions & MeSH terms

• Nail Psoriasis
• Psoriasis

Intervention

Device:
• Excimer laser
Excimer laser will be started at a dose of 300 mj/cm2 and increases 50-100 mj/cm2 each session. The aim of treatment is to deliver a dose that induces visible redness in the psoriatic lesion (supra-erythematous dose), but not induce a blister.

Drug:
• Methotrexate Injection
A ring block with 0.5 mL plain lignocaine (2%) will be administered in the web spaces on either side of the digit, followed by a 2.5-mg intramatrical methotrexate injection into each side of the nail at a point 2.5 mm proximal and lateral to the junction of proximal and lateral nail folds.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Nail Psoriasis Severity Index (mNAPSI)	The mNAPSI scores, ranging from 0 to 3 (pitting, onycholysis, and crumbling) depending on the area of the nail involved, will be calculated and digital photographs of the nails will be taken at baseline, monthly till 3 months of treatment, and 6 months after the end of treatment.	6 months