ClinicalTrials.gg
CompletedNCT07875608Updated Oct 15, 2026

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

A Phase 2 interventional study of Methotrexate and Triamcinalone Acetonide in Nail Psoriasis, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 16 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Tanta University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 5 months after the study started (first participant enrolled May 2023, registered Oct 2026).
Updated Oct 15, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Non-randomized
Ages
16 Years to 50 Years
Sex
All
01

Study 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.

The main questions it aims to answer are:

  • 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.

02

Conditions studied

  • Nail Psoriasis

Keywords

  • Nail psoriasis
  • NAPSI
  • intralesional methotrexate
  • intralesional acetonide
  • nail ultrasound
03

In context

Lead sponsor

Tanta University is the lead sponsor of 987 studies on the registry; 313 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Patients with concomitant onychomycosis.
  2. Patients with other nail disorders and diseases that interfere with the procedures and results, including nail trauma.
  3. Patients using concomitant drug therapy affecting the nail.
  4. Patients with concomitant other dermatological disease or any systemic disease.
  5. Pregnancy and lactation.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Methotrexate Arm

    Each 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.

    Drug: Methotrexate

  • Experimental
    Triamcinolone Acetonide Arm

    Each 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.

    Drug: Triamcinalone Acetonide

Interventions

  • 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.

  • DrugTriamcinalone Acetonide

    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.

06

What researchers measure

Primary outcomes

  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.

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

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: From the first treatment session through 6 months.

07

Study locations

1 site
  • Tanta University Hospital,Department of Dermatology and Venereology
    Tanta, Gharbia Governorate, Egypt
08

References and documents

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

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07875608
Lead sponsor
Tanta University
Responsible party
Yomna Mazid El-Hamd Neinaa (Professor of Dermatology and Venereology, Tanta University) — Principal investigator
First posted
Oct 15, 2026
Start date
May 1, 2023
Primary completion
Mar 10, 2025
Completion
Jun 15, 2025
Last update
Oct 15, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Methotrexate

Start the discussion