Eczema/Atopic DermatitisNCT07525505
Nigella Sativa Oil for Eczematous Otitis Externa
A study testing Mometasone Furoate (MF) and Nigella sativa oil in people with Eczema/Atopic Dermatitis and Otitis Externa, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eczema/Atopic Dermatitis, Otitis Externa
- What is being tested?
- Mometasone Furoate (MF) and Nigella sativa oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jan 2026to Jul 2026
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem Vakif University
Istanbul, Fatih, 34093
Nazan Degirmenci, Assoc. Prof., +90(212) 523 22 88, nzndegirmenci@hotmail.com
About this study
Official title: Efficacy of Nigella Sativa Oil in Eczematous Otitis Externa: A Randomized Controlled Study
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.
Read more
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.
Read the 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.
- Conditions
- Eczema/Atopic Dermatitis, Otitis Externa
- Being tested
- Mometasone Furoate (MF), Nigella sativa oil
- Keywords
- Eczematous Otitis Externa, External Ear Dermatitis, Nigella sativa oil
- Medical subject headings
- Eczema, Dermatitis, Atopic, Otitis Externa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mometasone Furoate (MF)Drug
Topical corticosteroid solution administered as ear drops (2 drops twice daily for 10 days).
Nigella sativa oilDrug
A fixed oil obtained from Nigella sativa seeds, administered as ear drops (2 drops twice daily for 10 days).
| Study group | Role | What they receive |
|---|---|---|
| nigella sativa | Experimental | Participants in this group will receive Nigella sativa oil ear drops, administered as two drops into the affected ear twice daily for 10 days. Receives: Drug: Nigella sativa oil |
| mometasone furoate | Active comparator | 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. Receives: Drug: Mometasone Furoate (MF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Day 10
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start12 Jan 2026
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eczema/Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazan Degirmenci, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525505
- Sponsor's protocol ID
- BVU-KBB-EKDE-01
- Status last verified
- Jan 2026
- First submitted
- 7 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Nigella Sativa Oil in Eczematous Otitis Externa: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07525505
- Acronym / sponsor ID
- BVU-KBB-EKDE-01
- Conditions
- Eczema/Atopic Dermatitis, Otitis Externa
- Keywords
- Eczematous Otitis Externa, External Ear Dermatitis, Nigella sativa oil
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 13 Apr 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| nigella sativa | Experimental | Drug: Nigella sativa oilParticipants in this group will receive Nigella sativa oil ear drops, administered as two drops into the affected ear twice daily for 10 days. |
| mometasone furoate | Active comparator | Drug: Mometasone Furoate (MF)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Mometasone Furoate (MF)Topical corticosteroid solution administered as ear drops (2 drops twice daily for 10 days). | Drug | mometasone furoate |
| Nigella sativa oilA fixed oil obtained from Nigella sativa seeds, administered as ear drops (2 drops twice daily for 10 days). | Drug | nigella sativa |
Primary outcome
Change in objective inflammatory findings of the external ear from baseline to Day 10
Time frame: 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.
4 secondary outcomes
Change in itching score from baseline to Day 10
Time frame: Baseline to Day 10
Change in pain score from baseline to Day 10
Time frame: Baseline to Day 10
Change in discomfort score from baseline to Day 10
Time frame: Baseline to Day 10
Change in otorrhea score from baseline to Day 10
Time frame: Baseline to Day 10
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 21 Apr 2026.
- Individual participant dataSharing planned: 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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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mometasone Furoate (MF) and Nigella sativa oil in people with Eczema/Atopic Dermatitis and Otitis Externa, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 21 Apr 2026. 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 Turkey (Türkiye). 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.
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?
Contact Nazan Degirmenci, MD,Assoc. Prof. (+90(212) 523 22 88, nzndegirmenci@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in objective inflammatory findings of the external ear from baseline to Day 10 (time frame: Baseline to Day 10). 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 21 Apr 2026.