Nail PsoriasisNCT06150794
Methotrexate Alone vs Combination With Excimer Light in Nail Psoriasis
A study testing Excimer laser and Methotrexate Injection in people with Nail Psoriasis, run by Assiut University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nail Psoriasis
- What is being tested?
- Excimer laser and Methotrexate Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnant or lactating woman
- Patients with history of photosensitivity or keloid formation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra-matrical Methotrexate Alone Versus Its Combination With Excimer Light in Treatment of Nail Psoriasis
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
Read the detailed 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.
- Conditions
- Nail Psoriasis
- Being tested
- Excimer laser, Methotrexate Injection
- Keywords
- Nail psoriasis, chronic psoriasis, methotrexate, excimer laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excimer laserDevice
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 InjectionDrug
Also called Intra-lesional
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Excimer laser; Drug: Methotrexate Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nail PsoriasisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manar Elammary, Assiut University
- Investigators
- Sahar Abdel-Moez, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150794
- Sponsor's protocol ID
- ASU-MTX
- Status last verified
- Nov 2023
- First submitted
- 21 Nov 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-matrical Methotrexate Alone Versus Its Combination With Excimer Light in Treatment of Nail Psoriasis
- ClinicalTrials.gov ID
- NCT06150794
- Acronym / sponsor ID
- ASU-MTX
- Conditions
- Nail Psoriasis
- Keywords
- Nail psoriasis, chronic psoriasis, methotrexate, excimer laser
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MTX alone (arm 1) | Active comparator | Drug: Methotrexate InjectionParticipants 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. |
| MTX + EL (arm 2) | Active comparator | Device: Excimer laser, Drug: Methotrexate InjectionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Pregnant or lactating woman
- Patients with history of photosensitivity or keloid formation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Excimer laserExcimer 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. | Device | MTX + EL (arm 2) |
| Methotrexate InjectionAlso: Intra-lesionalA 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. | Drug | MTX + EL (arm 2), MTX alone (arm 1) |
Primary outcome
Modified Nail Psoriasis Severity Index (mNAPSI)
Time frame: 6 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sahar Abdel-Moez, MD principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Excimer laser and Methotrexate Injection in people with Nail Psoriasis, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manar Elammary, MD (+2010002060881, Manar.elammary24@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Nail Psoriasis Severity Index (mNAPSI) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.