Methotrexate Alone vs Combination With Excimer Light in Nail Psoriasis
NCT ID: NCT06150794
Last Updated: 2023-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2023-12-01
2025-03-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MTX alone (arm 1)
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.
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.
MTX + EL (arm 2)
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.
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients will be included after they have stopped any systemic therapy for at least 8 weeks.
Exclusion Criteria
* Patients with history of photosensitivity or keloid formation.
18 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Manar Elammary
Investigator
Principal Investigators
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Sahar Abdel-Moez, MD
Role: PRINCIPAL_INVESTIGATOR
Assiut University
Locations
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Faculty of Medicine
Asyut, , Egypt
Countries
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Central Contacts
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Other Identifiers
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ASU-MTX
Identifier Type: -
Identifier Source: org_study_id