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.
Phase: PHASE3
Conditions: Chronic Paronychia
Sponsor: Cairo University

                                                                                                           
 
Protocol ID: N-255-2024 
NCT Number: Not yet assigned 
1 
 
Final Version: August 2024
Faculty of Medicine, Cairo University Postgraduate Research Protocol Template 
(Please read carefully provided guidance documents for a comprehensive understanding and 
proper formulation of your thesis protocol and required forms) 
 
1. Study 
 
a- Proposed Study 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 
2. Investigators Contact Information 
  
a.   Principal Investigator: Name: Professor Mohamed Hussein Medhat El-Komy 
                                          Department: Dermatology 
Phone number: 01223415852. 
E-mail addresses: mkomy@hotmail.com 
b.Other Investigators:  
 
1- Name: Yousra Abdul-Salam Muhammad Hasan Azzazi 
    Department: Dermatology 
    Phone: 01098709984 
    Email: yosrazzazi@cu.edu.eg 
2- Name: Habiba Khaled Mostafa Edrees 
    Department: Dermatology 
    Phone: 01004545118             
    Email: Habibaedrees@gmail.com 
3- Name: Basant Ahmed Mohamed Abdelaal Helal 
    Department: Dermatology 
    Phone: 011 44166922           
    Email: basant_helal@hotmail.com 
4- Name: Khadija Abdullah Hussein Affify 
    Department: Dermatology 
    Phone:  01018198885            
    Email: Khadijaabdullah9392@gmail.com 

                                                                                                           
 
Protocol ID: N-255-2024 
NCT Number: Not yet assigned 
2 
 
Final Version: August 2024
 
 
1. Background and Rationale 
 
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) 

                                                                                                           
 
Protocol ID: N-255-2024 
NCT Number: Not yet assigned 
3 
 
Final Version: August 2024
3. Objectives: (describe specific objectives or hypotheses behind the 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. 
 
4. Study Design: (Please fill in the appropriate study design, see attached PDF guide) 
  
- 
Descriptive: - Survey (cross sectional)   
                   - Qualitative 
 
- 
Analytic: - Observational: - Case-control study 
                                        - Cross sectional analytic study 
                                        - Cohort (Longitudinal) study 
 
              - Experimental: - Randomized Clinical Trial                      
                                       - Non-randomized clinical trial 
                                       - Animal study 
                                       - Cellular study 
 
- 
Others:   Please describe:        
            
5. Study Methods 
- 
Population of study: (Please provide all details regarding participants including 
gender, age range and disease conditions. Also indicate if this protocol involves 
children, prisoners, pregnant women or cognitively impaired or mentally disabled 
subjects): 
1-Age above 18 years 
2-Both sexes 
- 
Study location: (Please provide where the study will be conducted and from where 
study participants will be recruited) 

                                                                                                           
 
Protocol ID: N-255-2024 
NCT Number: Not yet assigned 
4 
 
Final Version: August 2024
Dermatology outpatient clinic, Kasr AlAiny, Faculty of medicine, Cairo University 
- 
Inclusion criteria: 
1-Patients with chronic paronychia affecting ≥ 2 fingernails in the dominant hand. 
2- Patients not receiving any relevant systemic treatment for at least 4 weeks before 
initiation 
of 
our 
study 
3- Patients not receiving any relevant topical treatment for at least 2 weeks before 
initiation of our study 
 
- 
Exclusion criteria: 
1- 
Patient 
with 
peripheral 
vascular 
disease 
or 
Raynaud’s 
phenomenon 
2-Pregnant 
and 
lactating 
females 
3-Patients with autoimmune diseases e.g., connective tissue diseases, psoriasis, reactive 
arthritis, and pemphigus. 
4-Patients with solid or hematological malignancies. 
5- Patients on systemic drugs that are known to cause chronic paronychia e.g. retinoids. 
6- Patients with any visible focus of infection at the injection site or in the vicinity, including 
patients with superimposed attack of acute paronychia. 
7-Onychomycosis or any associated nail disease 
 
 
- 
Methodology in details: 
 
Each participant will be subjected to: 
1- Written informed consent. 
2- Detailed history taking and clinical evaluation. 
3- Clinical photographing 
4- CP severity index scale (Atiş et al, 2018): On the scale, a dermatologist evaluates: 
• The proximal and lateral nail folds (involvement of 1 nail fold = 1; 
involvement of 2 nail folds [proximal or/and lateral] = 2; bilateral lateral nail 
fold involvement and proximal nail fold involvement = 3). 
• Edema (absent = 0; mild = 1; moderate = 2; severe = 3). 
• Erythema (absent = 0; mild = 1; moderate = 2; severe = 3). 
• Nail plate changes (absent = 0; mild = 1; moderate = 2; severe = 3). 
• Cuticle involvement (normal = 0; damaged = 1; absent = 2). 
A combined total score of (between 0 [min.] and 14 [max.]) is finally 
calculated. 
5- Assessment of disease impact: Dermatology Life Quality Index (DLQI). 
6- Assessment of pain severity by visual analogue scale (VAS) 

                                                                                                           
 
Protocol ID: N-255-2024 
NCT Number: Not yet assigned 
5 
 
Final Version: August 2024
7- All patients are advised to strictly avoid moist environments and irritants. 
The affected fingernails in each patient are randomized, by simple randomization technique, 
to either receive intralesional or topical treatment. 
• 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. 
• Procedure: 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. 
• The CP severity index scale, DLQI and VAS will be documented monthly till the end 
of treatment period and 1 month after stoppage of treatment. 
• Moreover, the pain associated with the intervention procedure will be evaluated using 
the VAS score immediately after the first session.  
• Percentage of Participants with treatment- related Adverse Events (AEs) and Serious 
Adverse Events (SAEs) will be documented. 
- 
Intervention: 
 
- 
Diagnostic intervention (please describe):     
 
- 
Therapeutic intervention (please describe):         
 
- 
No intervention  
 
 
- 
Does the research involve? 
          Human participants 
          Biological samples/Tissues 
          Identifiable private data/Information     
 
 

                                                                                                           
 
Protocol ID: N-255-2024 
NCT Number: Not yet assigned 
6 
 
Final Version: August 2024
- 
Type of consent of study participants: 
 
          Written consent 
          Oral consent 
          No consent needed (Please justify) 
- 
Potential risks:  
(Please mention all risks involved even mild ones as pain, discomfort, chance of 
infection) 
Pain at site of injection (measured by VAS), subungual hematoma, proximal nail fold 
hypopigmentation and atrophy (all these complications are largely preventable and 
fortunately reversible).  
Nicolau syndrome (Embolia cutis medicamentosa) is a very rare complication. 
 
- 
Confidentiality of data: (Please explain how privacy and confidentiality of data and 
records will be maintained)  
All participants’ data will be confidential. 
 
      9- Study outcomes: 
- 
Primary outcomes (Most important measurable outcomes) 
• Comparison between the mean CP severity index scale before and after treatment in 
each group 
• Comparison of absolute change in CP severity index scale between both groups 
• Comparison of percentage of patients who achieved complete response (CP severity 
index scale =0) between both groups. 
 
- Secondary outcome parameters (other outcomes to be assessed): 
• Comparison of DLQI before and after treatment in each group 
• Comparison of VAS before and after treatment in each group 
• Comparison of absolute change in DLQI between both groups 
• Comparison of absolute change in VAS between both groups 
• Comparison of percentage of patients who developed treatment related side effects in 
each group. 
 

                                                                                                           
 
Protocol ID: N-255-2024 
NCT Number: Not yet assigned 
7 
 
Final Version: August 2024
         10- Sample size (number of study subjects included and justification including the 
clinical and statistical assumptions supporting sample size calculation) 
As considered the primary outcome, sample size calculation was done using the comparison 
of absolute change in CP severity index scale between both groups. Since this is the first study 
to be conducted on these parameters, a moderate to large effect size corresponding to Cohen's 
d=0.7 was assumed to be clinically significant. A statistical power analysis was performed for 
sample size calculation; with a two tailed alpha error probability set at 0.05, the projected 
sample size needed for the aforementioned effect size (d=0.7) is 19 patients to be able to reject 
the null hypothesis that this difference is zero with probability (power) 0.80. To account for 
expected 10% dropouts and to allow for sub-group analysis, a sample of 21 patients will be 
recruited. Sample size calculation was done using G*Power 3.1.9.2. 
         11- Statistical analysis (Please describe your data analysis plan) 
Data will be collected anonymously and stored in a secure spreadsheet with unidentifiable 
keys. Normally distributed numerical data will be statistically described in terms of mean 
and standard deviation (SD), while not-normal data will be represented as median and range 
or inter-quartile range (IQR). Qualitative (categorical) data will be described in frequencies 
(number of cases) and percentage. Numerical data will be tested for the normal assumption 
using Kolmogorov Smirnov test. 
Statistical analysis will be performed using the appropriate tests; on qualitative variables by 
Fisher's exact test and on quantitative variables by non-normal Wilcoxon rank-sum test and 
Wilcoxon signed-rank test. A probability value (p value) of less than 0.05 is considered 
statistically significant.  
All statistical calculations will be done using computer programs Microsoft Excel 2019 
(Microsoft Corporation, NY, USA) and IBM SPSS (Statistical Package for the Social Science; 
IBM Corp, Armonk, NY, USA) release 22 for Microsoft Windows. 
 
         12- Source of funding: (Please include source of funding even if self-funding) 
 
- 
Faculty of Medicine, Cairo University  
- 
Other sources: 
Please specify: Self funding 

                                                                                                           
 
Protocol ID: N-255-2024 
NCT Number: Not yet assigned 
8 
 
Final Version: August 2024
References: 
 
• Atış, G., Göktay, F., Altan Ferhatoğlu, Z., Kaynak, E., Sevim Keçici, A., Yaşar, Ş., & 
Aytekin, S. (2018). A proposal for a new severity index for the evaluation of chronic 
paronychia. Skin Appendage Disorders, 5(1), 32-37. 
• Bahunuthula RK, Thappa DM, Kumari R, Singh R, Munisamy M, Parija SC. 
Evaluation of role of Candida in patients with chronic paronychia. Indian J Dermatol 
Venereol Leprol. 2015;81(5):485-490. doi:10.4103/0378-6323.158635 
• Baran, R. (2001). Common‐sense advice for the treatment of selected nail 
disorders. Journal of the European Academy of Dermatology and 
Venereology, 15(2), 97-102. 
• Relhan, V., & Bansal, A. (2022). Acute and chronic paronychia revisited: A narrative 
review. Journal of Cutaneous and Aesthetic Surgery, 15(1), 1-16. 
• Relhan, V., Goel, K., Bansal, S., & Garg, V. K. (2014). Management of chronic 
paronychia. Indian Journal of Dermatology, 59(1), 15-20. 
• Shafritz, A. B., & Coppage, J. M. (2014). Acute and chronic paronychia of the 
hand. JAAOS-Journal of the American Academy of Orthopaedic Surgeons, 22(3), 
165-174. 
• Tosti, A., Piraccini, B. M., Ghetti, E., & Colombo, M. D. (2002). Topical steroids 
versus systemic antifungals in the treatment of chronic paronychia: an open, 
randomized double-blind and double dummy study. Journal of the American 
Academy of Dermatology, 47(1), 73-76. 
    
1- Please fill in all the included sections and don’t delete any part of the template 
2- For choice brackets, please just use the fill in function in word 
 
 
 
 
 
 
 
 
 
 

                                                                                                           
 
Protocol ID: N-255-2024 
NCT Number: Not yet assigned 
9 
 
Final Version: August 2024

                                                                                                           
 
Protocol ID: N-255-2024 
NCT Number: Not yet assigned 
10 
 
Final Version: August 2024