Chronic ParonychiaPhase 3NCT07311759
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.
A Phase 3 study testing Intralesional triamcinolone acetonide and fluconazole and Topical mometasone furoate and miconazole nitrate, Elica-M® in people with Chronic Paronychia, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Paronychia
- What is being tested?
- Intralesional triamcinolone acetonide and fluconazole and Topical mometasone furoate and miconazole nitrate, Elica-M®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Aug 2024to May 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Chronic paronychia (CP) is defined as inflammation of the nail fold(s) of more than 6 weeks duration (Shafritz and Coppage, 2014). It is now considered as a form of hand eczema, caused primarily by irritation of the nail folds by environmental allergens. This leads to recurrent inflammation of nail folds, followed by fibrosis and inability to generate the cuticle, ending in loss of the waterproof seal, moisture retention, and compromise of blood supply due to fibrosis. These can explain why CP is commonly resistant to topical and even systemic treatments. Candida infection is thought to be a secondary event in a subset of cases (Relhan and Bansal, 2022), with positive fungal culture in about 56.1% of cases (Bahunuthula et al., 2015) Important risk factors for the development of CP include occupations with excessive exposure to moisture and irritants (e.g. housewives, cooks, and health care providers), immunosuppression (e.g. diabetes mellitus and HIV); due to increased risk of secondary colonization, and some medications (e.g. retinoids) (Relhan and Bansal, 2022). A higher incidence of contact sensitization and Candida hypersensitivity in these patients has been reported, (Bahunuthula et al., 2015) thus candidal control may be of help to ameliorate the disease.
Clinically, CP presents with erythema, pain and swelling of one or more of the nail folds for >6 weeks. It generally affects multiple fingernails, more commonly, of the dominant hand. Nail matrix may be secondarily affected leading to transverse ridging, discoloration, Beau's lines, or onychomadesis (Shafritz and Coppage, 2014, Atiş et al.,2018). The last updated severity scale for CP has been proposed in 2018, taking into account the number of affected nail folds, erythema, edema, nail plate and cuticle changes (Atiş et al.,2018).
Management of CP relies mainly on avoidance of the irritants and topical corticosteroids which are now considered the mainstay of treatment (Shafritz and Coppage, 2014). Systemic antifungals are used in cases with associated candida infection (Tosti et al., 2002).
Intralesional steroid injection, in the form of monthly injections of triamcinolone acetonide (2.5- 10 mg/mL), is used for the treatment of nail psoriasis, nail lichen planus and twenty-nail dystrophy. It is, however, scarcely mentioned in literature in the management of CP (Baran, 2001). In addition, the optimal treatment regimen and injection technique have not yet been established, and no recent relevant studies exist.
Surgical treatment is reserved for cases of CP of more than 6-month duration, that has been resistant to medical treatment (Relhan et al., 2014)
- Conditions
- Chronic Paronychia
- Being tested
- Intralesional triamcinolone acetonide and fluconazole, Topical mometasone furoate and miconazole nitrate, Elica-M®
- Keywords
- Intralesional triamcinolone, Chronic paronychia, Intralesional fluconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intralesional triamcinolone acetonide and fluconazoleDrug
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Topical mometasone furoate and miconazole nitrate, Elica-M® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start17 Aug 2024
- Primary completion4 Dec 2025
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic ParonychiaStudies of the same condition, open and under way.
- More trials run by Cairo 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- The affected fingernails in each patient are randomized, by simple randomization technique, to either receive intralesional or topical treatment.
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basant Ahmed Mohamed Abdelaal Helal, Cairo University
- Investigators
- Yousra A Azzazi, Lecturer of Dermatology, Study director, Cairo UniversityMohamed M El-Komy, Professor of Dermatology, Study chair, Cairo UniversityHabiba K Edrees, Dermatology Resident, Principal investigator, Cairo UniversityKhadija A Affify, Dermatology resident, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311759
- Sponsor's protocol ID
- N-255-2024
- Status last verified
- Nov 2025
- First submitted
- 5 Aug 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07311759
- Acronym / sponsor ID
- N-255-2024
- Conditions
- Chronic Paronychia
- Keywords
- Intralesional triamcinolone, Chronic paronychia, Intralesional fluconazole
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 17 Aug 2024 (actual)
- Primary completion
- 4 Dec 2025 (actual)
- Study completion
- May 2026 (estimated)
- First posted
- 31 Dec 2025 (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.
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.
Detailed description
Chronic paronychia (CP) is defined as inflammation of the nail fold(s) of more than 6 weeks duration (Shafritz and Coppage, 2014). It is now considered as a form of hand eczema, caused primarily by irritation of the nail folds by environmental allergens. This leads to recurrent inflammation of nail folds, followed by fibrosis and inability to generate the cuticle, ending in loss of the waterproof seal, moisture retention, and compromise of blood supply due to fibrosis. These can explain why CP is commonly resistant to topical and even systemic treatments. Candida infection is thought to be a secondary event in a subset of cases (Relhan and Bansal, 2022), with positive fungal culture in about 56.1% of cases (Bahunuthula et al., 2015) Important risk factors for the development of CP include occupations with excessive exposure to moisture and irritants (e.g. housewives, cooks, and health care providers), immunosuppression (e.g. diabetes mellitus and HIV); due to increased risk of secondary colonization, and some medications (e.g. retinoids) (Relhan and Bansal, 2022). A higher incidence of contact sensitization and Candida hypersensitivity in these patients has been reported, (Bahunuthula et al., 2015) thus candidal control may be of help to ameliorate the disease.
Clinically, CP presents with erythema, pain and swelling of one or more of the nail folds for >6 weeks. It generally affects multiple fingernails, more commonly, of the dominant hand. Nail matrix may be secondarily affected leading to transverse ridging, discoloration, Beau's lines, or onychomadesis (Shafritz and Coppage, 2014, Atiş et al.,2018). The last updated severity scale for CP has been proposed in 2018, taking into account the number of affected nail folds, erythema, edema, nail plate and cuticle changes (Atiş et al.,2018).
Management of CP relies mainly on avoidance of the irritants and topical corticosteroids which are now considered the mainstay of treatment (Shafritz and Coppage, 2014). Systemic antifungals are used in cases with associated candida infection (Tosti et al., 2002).
Intralesional steroid injection, in the form of monthly injections of triamcinolone acetonide (2.5- 10 mg/mL), is used for the treatment of nail psoriasis, nail lichen planus and twenty-nail dystrophy. It is, however, scarcely mentioned in literature in the management of CP (Baran, 2001). In addition, the optimal treatment regimen and injection technique have not yet been established, and no recent relevant studies exist.
Surgical treatment is reserved for cases of CP of more than 6-month duration, that has been resistant to medical treatment (Relhan et al., 2014)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The affected fingernails in each patient are randomized, by simple randomization technique, to either receive intralesional or topical treatment.
| Arm | Type | Receives |
|---|---|---|
| Intralesional Triamcinolone acetonide and fluconazole | Active comparator | Drug: Intralesional triamcinolone acetonide and fluconazoleThe 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 |
| Topical treatment with mometasone furoate and miconazole nitrate | Active comparator | Drug: Topical mometasone furoate and miconazole nitrate, Elica-M®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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Intralesional triamcinolone acetonide and fluconazoleTriamcinolone 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. | Drug | Intralesional Triamcinolone acetonide and fluconazole |
| Topical mometasone furoate and miconazole nitrate, Elica-M®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 treatment with mometasone furoate and miconazole nitrate |
Primary outcome
Comparison between the chronic paronychia severity index scale before and after treatment in each group
Time frame: 4 months
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
Comparison of the change in chronic paronychia severity index scale between both groups
Time frame: 4 months
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.
Comparison of percentage of patients who achieved complete response (chronic paronychia severity index scale =0) between both groups.
Time frame: 4 months
We will assess whether the patient had a complete response or not according to the chronic paronychia severity index scale equals to zero
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: Undecided
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.
Yousra A Azzazi, Lecturer of Dermatology study director
Cairo University
Mohamed M El-Komy, Professor of Dermatology study chair
Cairo University
Habiba K Edrees, Dermatology Resident principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intralesional triamcinolone acetonide and fluconazole and Topical mometasone furoate and miconazole nitrate, Elica-M® in people with Chronic Paronychia, run by Cairo 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 3 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 31 Dec 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Comparison between the chronic paronychia severity index scale before and after treatment in each group (time frame: 4 months). The study lists 3 primary outcomes in all. 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 31 Dec 2025.