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Nail PsoriasisPhase 2NCT07875608

Comparative Study of Intralesional Methotrexate Versus Intralesional Triamcinolone Acetonide in Treatment of Nail Psoriasis

A Phase 2 study testing Methotrexate and Triamcinalone Acetonide in people with Nail Psoriasis, run by Tanta University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to compare methotrexate injections with triamcinolone acetonide injections for treating nail psoriasis. Nail psoriasis can cause nail pitting, discoloration, thickening, and separation of the nail from the skin underneath. The study will also compare the safety of these treatments. Read more about this study

Who is it for?
Ages 16 to 50 years
Conditions the study is for
Nail Psoriasis
What is being tested?
Methotrexate and Triamcinalone Acetonide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteEgypt
Study dates
1 May 2023to 15 Jun 2025
Phase
Phase 2
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 16 to 50 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patients with bilateral clinically significant nail psoriasis resistant to different treatment modalities.
  • Patients who did not receive any topical or systemic treatment for nail psoriasis in the preceding 3 months and throughout the study.

Who cannot join

  • Patients with concomitant onychomycosis.
  • Patients with other nail disorders and diseases that interfere with the procedures and results, including nail trauma.
  • Patients using concomitant drug therapy affecting the nail.
  • Patients with concomitant other dermatological disease or any systemic disease.
  • Pregnancy and lactation.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Tanta University Hospital,Department of Dermatology and Venereology

    Tanta, Gharbia Governorate

Other trials in Egypt

About this study

Official title: Single Blinded Left to Right Comparative Study of Intralesional Methotrexate Versus Intralesional Triamcinolone Acetonide in Treatment of Nail Psoriasis

The goal of this clinical trial is to compare methotrexate injections with triamcinolone acetonide injections for treating nail psoriasis. Nail psoriasis can cause nail pitting, discoloration, thickening, and separation of the nail from the skin underneath. The study will also compare the safety of these treatments.

The main questions it aims to answer are:

Read more
  • Which treatment produces greater improvement in nail psoriasis?
  • What side effects do participants experience with each treatment?

Researchers will compare methotrexate with triamcinolone acetonide. Both medications will be injected intralesionally into the affected nail area.

Participants will:

  • Receive intralesional injections according to the study treatment plan.
  • Attend clinic visits to assess changes in their affected nails and check for side effects.
  • Report any pain, discomfort, or other medical problems experienced during the study.
Read the detailed description

The goal of this clinical trial is to compare methotrexate injections with triamcinolone acetonide injections for treating nail psoriasis. The study will also compare the safety of the two treatments.

The study will include 25 participants with nail psoriasis affecting both sides that has not responded well to previous treatments. Participants will be recruited from the Dermatology and Venereology Outpatient Clinic at Tanta University Hospital.

The main questions it aims to answer are:

  • Which treatment produces greater improvement in nail psoriasis?
  • What side effects occur with each treatment?
  • How do the nails change during the three months after treatment ends?

Each participant will receive both treatments. Affected nails on one side will receive methotrexate injections, while those on the other side will receive triamcinolone acetonide injections. This allows researchers to compare the two treatments in the same person.

Participants will:

  • Have their medical history reviewed and undergo a general, skin, and nail examination.
  • Receive injections every two weeks, for up to six sessions or until improvement.
  • Have nail severity measured before and after treatment using the Nail Psoriasis Severity Index (NAPSI).
  • Have their nails examined at each treatment visit using a dermoscope, a device that provides a magnified view.
  • Have nail photographs and ultrasound scans taken before and after treatment.
  • Receive local numbing injections and ice packs to reduce discomfort during treatment.
  • Attend follow-up visits once a month for three months after the last treatment session.
  • Report pain, discomfort, bleeding beneath the nail, or other medical problems.

Participants must not have used topical or systemic treatments for nail psoriasis during the three months before joining and must avoid these other treatments during the study. Participation is voluntary, and participants may leave the study at any time.

Conditions
Nail Psoriasis
Being tested
Methotrexate, Triamcinalone Acetonide
Keywords
Nail psoriasis, NAPSI, intralesional methotrexate, intralesional acetonide, nail ultrasound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MethotrexateDrug

    Methotrexate at a concentration of 25 mg/mL will be injected intralesionally into the affected nail area on one side of each participant. Injections will be given every two weeks for a maximum of six sessions or until improvement.

  • Triamcinalone AcetonideDrug

    Triamcinolone acetonide at a concentration of 10 mg/mL will be injected intralesionally into the affected nail area on the side opposite to that receiving methotrexate. Injections will be given every two weeks for a maximum of six sessions or until improvement.

Study groups in NCT07875608
Study groupRoleWhat they receive
Methotrexate ArmExperimentalEach participant will receive intralesional methotrexate on one side. Treatment sessions will take place every two weeks for up to six sessions or until improvement. Treatment responses and side effects will be compared between the two sides.
Receives: Drug: Methotrexate
Triamcinolone Acetonide ArmExperimentalEach participant will receiveintralesional triamcinolone acetonide on the other side. Treatment sessions will take place every two weeks for up to six sessions or until improvement. Treatment responses and side effects will be compared between the two sides.
Receives: Drug: Triamcinalone Acetonide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Target Nail Psoriasis Severity Index (NAPSI) Score at 3 and 6 Months

    NAPSI will be assessed for one target nail on each side of each participant at baseline and at 3 and 6 months after the first treatment session. The nail is scored from 0 to 8, with higher scores indicating more severe nail psoriasis. Changes from baseline will be compared between the methotrexate-treated nail and the triamcinolone acetonide-treated nail to assess treatment response and whether improvement is maintained. A decrease in score indicates improvement.

    Measured: Baseline, 3 months, and 6 months after the first treatment session.

Secondary outcomes (3)

  1. Changes from Baseline in Ultrasound Measurements of Target Nail Thickness

    Ultrasound will measure nail plate thickness, nail bed thickness, and nail matrix thickness in millimeters for one target nail on each treatment side. Changes from baseline in each measurement will be assessed separately and compared between the methotrexate-treated nail and the triamcinolone acetonide-treated nail within each participant.

    Measured: Baseline, 3 months, and 6 months after the first treatment session.

  2. Clinical improvemnt Assessed by Dermoscopy

    Dermoscopy will be used to assess changes in psoriasis signs in one target nail on each treatment side. Findings will be compared with baseline and between the methotrexate-treated nail and the triamcinolone acetonide-treated nail.

    Measured: From the first treatment session through 6 months.

  3. Number of Participants Experiencing Treatment-Related Adverse Events

    The number of participants experiencing treatment-related adverse events will be recorded for each treatment side. Events will include injection-site pain, depigmentation, subungual hematoma, and yellow discoloration. Findings will be compared between the methotrexate-treated side and the triamcinolone acetonide-treated side.

    Measured: From the first treatment session through 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2026
  2. Study start1 May 2023
  3. Primary completion10 Mar 2025
  4. Study completion15 Jun 2025

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
This is a within-participant, left-to-right comparative study. Each participant will receive intralesional methotrexate on one side and intralesional triamcinolone acetonide on the other side during the same treatment period.
Masking
Single blind
Who is masked
Participant
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07875608
Sponsor's protocol ID
35674/8/22
Status last verified
Oct 2026
First submitted
8 Oct 2026
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Oram Y, Akkaya AD. Treatment of nail psoriasis: common conceptsand new trends. Dermatol Res Pract. 2013; 2013:180496. Rigopoulos D, Baran R, Chiheb S, Daniel CR 3rd, Di Chiacchio N, Gregoriou S, et al. Recommendations for the definition, evaluation, and treatment of nail psoriasis in adult patients with no or mild skin psoriasis: a dermatologist and nail expert group consensus. J Am Acad Dermatol. 2019; 81(1):228-240. Crowley JJ, Weinberg JM, Wu JJ, Robertson AD, Van Voorhees AS. National Psoriasis Foundation: Treatment of nail psoriasis: best practice recommendations from the Medical Board of the National Psoriasis Foundation. JAMA Dermatol. 2015; 151:87-94. Rich P, Scher RK. Nail Psoriasis Severity Index: A useful tool for evaluation of nail psoriasis. J Am Acad Dermatol. 2003, 49, 206-212. Cassell SE, Bieber JD, Rich P, Tutuncu ZN, Lee SJ, Kalunian KC, et al. The modified Nail Psoriasis Severity Index: Validation of an instrument to assess psoriatic nail involvement in patients with psoriatic arthritis. J Rheumatol. 2007, 34, 123-129. Polat A, Kapıcıoğlu Y. Dermoscopic findings of psoriatic nail and their relationship with disease severity. Turkderm-Turk Arch Dermatol Venerology. 2017; 51: 119-23. Berritto D, Iacobellis F, Rossi C, Reginelli A, Cappabianca S, Grassi R. Ultra high-frequency ultrasound: New capabilities for nail anatomy exploration. J Dermatol. 2017, 44, 43-46. Szymoniak-Lipska M, Polan´ska A, Jenerowicz D, Lipski A, Zaba R, Adamski Z, Dan´czak-Pazdrowska A. High-Frequency Ultrasonography and Evaporimetry in Non-invasive Evaluation of the Nail Unit. Front Med. 2021, 8, 686470. Krajewska-Włodarczyk M, Owczarczyk-Saczonek A, Placek W, Wojtkiewicz M, Wiktorowicz A, Wojtkiewicz J. Ultrasound Assessment of Changes in Nails in Psoriasis and Psoriatic Arthritis. BioMed Res Int. 2018; 2018, 8251097. De Vries AC, Bogaards NA, Hooft L, Velema M, Pasch M, Lebwohl M, et al. Interventions for nail

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Methotrexate and Triamcinalone Acetonide in people with Nail Psoriasis, run by Tanta 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 5 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: finished, as of the sponsor's last update on 15 Oct 2026. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Target Nail Psoriasis Severity Index (NAPSI) Score at 3 and 6 Months (time frame: Baseline, 3 months, and 6 months after the first treatment session.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07875608, which also lists 1 linked publication.

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 15 Oct 2026.

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