Eczema/Atopic Dermatitis, Otitis Externa
Conditions
Keywords
Eczematous Otitis Externa, External Ear Dermatitis, Nigella sativa oil
Brief summary
Eczematous otitis externa is a common inflammatory condition of the external auditory canal characterized by itching, discomfort, discharge, and pain. Topical corticosteroids are widely used for treatment; however, alternative therapies with fewer side effects are of increasing interest. This study aims to compare the efficacy of Nigella sativa (black seed) oil and mometasone furoate ear drops in the treatment of eczematous otitis externa. Nigella sativa is a natural product with known anti-inflammatory and antimicrobial properties. In this randomized, controlled clinical trial, adult patients with eczematous otitis externa will be assigned to receive either Nigella sativa oil or mometasone furoate ear drops for 10 days. Clinical symptoms and inflammatory findings will be evaluated at baseline and after treatment. The objective of this study is to determine whether Nigella sativa oil is an effective and safe alternative to topical corticosteroid therapy.
Detailed description
Eczematous otitis externa is a chronic inflammatory condition of the external auditory canal characterized by pruritus, erythema, scaling, and discomfort. Although topical corticosteroids are commonly used as first-line therapy, their prolonged use may be associated with adverse effects, prompting interest in alternative treatment options. Nigella sativa oil, a natural product with documented anti-inflammatory, antioxidant, and antimicrobial properties, may represent a potential therapeutic alternative in inflammatory ear conditions. This study will be conducted as a prospective, randomized, single-blinded, controlled clinical trial. Adult patients with clinically diagnosed eczematous otitis externa will be randomly assigned in a 1:1 ratio to receive either Nigella sativa oil or mometasone furoate 0.1% ear drops, administered twice daily for 10 days. Clinical assessments will be performed at baseline and at the end of treatment. Patient-reported symptoms, including itching, discomfort, otorrhea, and pain, will be evaluated using a numeric rating scale. Objective inflammatory findings, including hyperemia and squamation of the external auditory canal and external ear, will be assessed using standardized photographic documentation by a blinded evaluator. The primary outcome will be the change in objective inflammatory findings from baseline to the end of treatment. Secondary outcomes will include changes in patient-reported symptom scores. The results of this study are expected to provide evidence regarding the efficacy and safety of Nigella sativa oil as a potential alternative to topical corticosteroid therapy in the management of eczematous otitis externa.
Interventions
Topical corticosteroid solution administered as ear drops (2 drops twice daily for 10 days).
A fixed oil obtained from Nigella sativa seeds, administered as ear drops (2 drops twice daily for 10 days).
Sponsors
Bezmialem Vakif University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Participants will be randomized in a 1:1 ratio to one of two parallel groups to receive either Nigella sativa oil or mometasone furoate. Outcomes will be assessed at baseline and after 10 days of treatment by a blinded evaluator.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients aged 18 years and older * Clinical diagnosis of eczematous otitis externa confirmed by otoscopic examination * Presence of at least one symptom related to the affected ear (itching, discomfort, otorrhea, or pain) * Willingness to participate and ability to provide written informed consent
Exclusion criteria
* Known hypersensitivity or allergic reaction to Nigella sativa oil or mometasone furoate * Use of topical or systemic corticosteroids or other ear medications within a defined period prior to enrollment * Presence of acute otitis externa of infectious origin requiring antibiotic treatment * History of ear surgery or structural abnormalities of the external auditory canal * Severe systemic disease or condition that may interfere with study participation * Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in objective inflammatory findings of the external ear from baseline to Day 10 | Baseline to Day 10 | Objective inflammatory findings, including external auditory canal hyperemia, edema, and desquamation, will be assessed using a standardized clinical inflammation scoring system (range: 0-3 for each parameter; total score range: 0-9). Higher scores indicate more severe inflammation. Changes in total score from baseline to Day 10 will be analyzed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in itching score from baseline to Day 10 | Baseline to Day 10 | Itching severity will be assessed using a Numeric Rating Scale (0-10). Changes from baseline to Day 10 will be evaluated. |
| Change in pain score from baseline to Day 10 | Baseline to Day 10 | Pain severity will be assessed using a Numeric Rating Scale (0-10). Changes from baseline to Day 10 will be evaluated. |
| Change in discomfort score from baseline to Day 10 | Baseline to Day 10 | Discomfort will be assessed using a Numeric Rating Scale (0-10). Changes from baseline to Day 10 will be evaluated. |
| Change in otorrhea score from baseline to Day 10 | Baseline to Day 10 | Otorrhea severity will be assessed using a Numeric Rating Scale (0-10). Changes from baseline to Day 10 will be evaluated. |
Countries
Turkey (Türkiye)
Contacts
CONTACTNazan Degirmenci, MD,Assoc. Prof.
CONTACTmuhammed said ekinci, resident MD
Outcome results
None listed