Safety and Efficacy of Intralesional 0.5% Triamcinolone Acetonide in 0.2% Fluconazole Solution vs 0.1% Topical Mometasone Furoate With 2% Miconazole Nitrate Cream in the Treatment of Chronic Paronychia: An Intraindividual Randomized Controlled Trial.

NCT07311759 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: N-255-2024
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Our objective is to compare the efficacy and safety of intralesional corticosteroids + fluconazole solution to corticosteroid with an antifungal topical preparation, in the management of chronic paronychia.

Conditions

Chronic Paronychia

Keywords

Intralesional triamcinolone; Chronic paronychia; Intralesional fluconazole

Outcome Measures

Primary Outcomes (3)

• Comparison between the chronic paronychia severity index scale before and after treatment in each group

  Evaluation of proximal and lateral nail fold involvement, edema, erythema, nail plate changes and cuticle involvement for each affected nail before and after treatment using the chronic paronychia severity index score according to Atis et al, 2018 to measure the efficacy of each group on its own

  4 months

• Comparison of the change in chronic paronychia severity index scale between both groups

  According also to Atis et al, 2018. We will grade the affected nails using the chronic paronychia severity index scale and measure the difference between before and after treatment between both groups, where pre-treatment evaluation to check for any bias and post-treatment to check which intervention was more superior.

  4 months

• Comparison of percentage of patients who achieved complete response (chronic paronychia severity index scale =0) between both groups.

  We will assess whether the patient had a complete response or not according to the chronic paronychia severity index scale equals to zero

  4 months

Study Arms (2)

Intralesional Triamcinolone acetonide and fluconazole

ACTIVE COMPARATOR

The proximal nail fold is cleansed with alcohol. Triamcinolone acetonide and fluconazole in the ratio of 1:7, yielding a triamcinolone acetonide concentration of 5mg/ml, is injected through the affected nail fold with a 30-gauge, 1-mL insulin syringe needle. The nail fold is divided into 2 halves and a maximum of 0.5 cc is injected in both halves or till there is swelling /edema of the nailfold. Injections are administered every 4 weeks until the end of treatment response, or for a maximum of 3 months

Drug: Intralesional triamcinolone acetonide and fluconazole

Topical treatment with mometasone furoate and miconazole nitrate

ACTIVE COMPARATOR

Topical treatment in the form of twice daily application of combined steroid and antifungal (mometasone furoate and miconazole nitrate, Elica-M®) till the end of treatment response or for a maximum of 3 months.

Drug: Topical mometasone furoate and miconazole nitrate, Elica-M®

Interventions

Intralesional triamcinolone acetonide and fluconazole DRUG

Triamcinolone acetonide and fluconazole in the ratio of 1:7, yielding a triamcinolone acetonide concentration of 5mg/ml, is injected through the affected nail fold with a 30-gauge, 1-mL insulin syringe needle.

Intralesional Triamcinolone acetonide and fluconazole

Topical mometasone furoate and miconazole nitrate, Elica-M® DRUG

Topical treatment in the form of twice daily application of combined steroid and antifungal (mometasone furoate and miconazole nitrate, Elica-M®) till the end of treatment response or for a maximum of 3 months.

Topical treatment with mometasone furoate and miconazole nitrate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic paronychia affecting ≥ 2 fingernails in the dominant hand.
• Patients not receiving any relevant systemic treatment for at least 4 weeks before initiation of our study
• Patients not receiving any relevant topical treatment for at least 2 weeks before initiation of our study

You may not qualify if:

• Patient with peripheral vascular disease or Raynaud's phenomenon
• Pregnant and lactating females
• Patients with autoimmune diseases e.g., connective tissue diseases, psoriasis, reactive arthritis, and pemphigus.
• Patients with solid or hematological malignancies.
• Patients on systemic drugs that are known to cause chronic paronychia e.g. retinoids.
• Patients with any visible focus of infection at the injection site or in the vicinity, including patients with superimposed attack of acute paronychia.
• Onychomycosis or any associated nail disease

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

Fluconazole; Mometasone Furoate; Miconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Imidazoles

Study Officials

• Yousra A Azzazi, Lecturer of Dermatology

  Cairo University

  STUDY DIRECTOR

• Mohamed M El-Komy, Professor of Dermatology

  Cairo University

  STUDY CHAIR

• Habiba K Edrees, Dermatology Resident

  Cairo University

  PRINCIPAL INVESTIGATOR

• Khadija A Affify, Dermatology resident

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatology Specialist

Model Details: The affected fingernails in each patient are randomized, by simple randomization technique, to either receive intralesional or topical treatment.

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: December 31, 2025
• Study Start: August 17, 2024
• Primary Completion: December 4, 2025
• Study Completion: May 1, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-11

Locations

EG (1)