Methotrexate Alone vs Combination With Excimer Light in Nail Psoriasis

NCT06150794 | Unknown

• 1 other identifier: ASU-MTX
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Nail Psoriasis

Keywords

Nail psoriasis; chronic psoriasis; methotrexate; excimer laser

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

MTX alone (arm 1)

ACTIVE COMPARATOR

Participants will receive intra-matrical methotrexate injection in the affected fingers of both hands, once a month for 3 months. Comparison arms represent right hand (MTX+EL) and left hand (MTX alone) in the same participants.

Drug: Methotrexate Injection

MTX + EL (arm 2)

ACTIVE COMPARATOR

Participants will receive excimer laser treatment in the affected fingers of the right hand only, in addition to treatment with methotrexate injection the same participants are receiving in the same hand. Excimer laser will be applied twice weekly for 3 months. Comparison arms represent right hand (MTX+EL) and left hand (MTX alone) in the same participants.

Device: Excimer laser; Drug: Methotrexate Injection

Interventions

Excimer laser DEVICE

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.

MTX + EL (arm 2)

Methotrexate Injection DRUG

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.

Also known as: Intra-lesional

MTX + EL (arm 2); MTX alone (arm 1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant or lactating woman
• Patients with history of photosensitivity or keloid formation.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine

Asyut, 71515, Egypt

Location

MeSH Terms

Interventions

Lasers, Excimer; Methotrexate

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sahar Abdel-Moez, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manar Elammary, MD

CONTACT

+2010002060881; Manar.elammary24@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: November 29, 2023
• Study Start: December 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: March 1, 2025
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)