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

NCT07875608 | Completed Phase 2

• 1 other identifier: 35674/8/22
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nail Psoriasis

Keywords

Nail psoriasis; NAPSI; intralesional methotrexate; intralesional acetonide; nail ultrasound

Outcome Measures

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.

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

Secondary Outcomes (3)

• Changes from Baseline in Ultrasound Measurements of Target Nail Thickness

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

• Clinical improvemnt Assessed by Dermoscopy

  From the first treatment session through 6 months.

• Number of Participants Experiencing Treatment-Related Adverse Events

  From the first treatment session through 6 months.

Study Arms (2)

Methotrexate Arm

EXPERIMENTAL

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

Triamcinolone Acetonide Arm

EXPERIMENTAL

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 DRUG

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.

Methotrexate Arm

Triamcinalone Acetonide DRUG

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.

Triamcinolone Acetonide Arm

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospital,Department of Dermatology and Venereology

Tanta, Gharbia Governorate, Egypt

Location

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Interventions

Methotrexate

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology and Venereology

Model Details: 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.

Study Record Dates

• First Submitted: October 8, 2026
• First Posted: October 15, 2026
• Study Start: May 1, 2023
• Primary Completion: March 10, 2025
• Study Completion: June 15, 2025
• Last Updated: October 15, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)