An interventional study of Mometasone Furoate (MF) and Nigella sativa oil in Eczema/Atopic Dermatitis and Otitis Externa, sponsored by Bezmialem Vakif University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by Bezmialem Vakif University · Not applicable, Interventional, and Treatment
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.
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.
503 studies on the registry are indexed under Eczema; 89 are open to participants now.
This study's planned enrollment of 85 is close to the median of 91 across 401 interventional studies indexed under Eczema.
Browse Eczema studies →Bezmialem Vakif University is the lead sponsor of 354 studies on the registry; 59 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will receive Nigella sativa oil ear drops, administered as two drops into the affected ear twice daily for 10 days.
Drug: Nigella sativa oil
Participants in this group will receive mometasone furoate 0.1% ear drops, administered as two drops into the affected ear twice daily for 10 days.
Drug: Mometasone Furoate (MF)
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).
Change in objective inflammatory findings of the external ear from 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.
Time frame: Baseline to Day 10
Change in itching score from 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.
Time frame: Baseline to Day 10
Change in pain score from 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.
Time frame: Baseline to Day 10
Change in discomfort score from baseline to Day 10
Discomfort will be assessed using a Numeric Rating Scale (0-10). Changes from baseline to Day 10 will be evaluated.
Time frame: Baseline to Day 10
Change in otorrhea score from 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.
Time frame: Baseline to Day 10
Plan to share: Undecided — It is currently undecided whether individual participant data (IPD) will be shared. Data sharing plans may be determined after study completion in accordance with institutional policies and applicable regulations.
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Studies of the drug tested here: Nigella sativa oil