Nigella Sativa Oil for Eczematous Otitis Externa

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Otitis Externa; Eczema/Atopic Dermatitis
• Intervention / Treatment: Drug: Nigella sativa oil; Drug: Mometasone Furoate (MF)

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 Type: Interventional
• Enrollment (Estimated): 85
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nazan Degirmenci, MD,Assoc. Prof.; Phone Number: +90(212) 523 22 88; Email: nzndegirmenci@hotmail.com
• Study Contact Backup: Name: muhammed said ekinci, resident MD; Phone Number: +90(212) 523 22 88; Email: muhammed.ekinci@bezmialem.edu.tr

Study Locations

• Turkey (Türkiye)
  • Fatih
    • Istanbul, Fatih, Turkey (Türkiye), 34093
      • Recruiting
      • Bezmialem Vakif University
      • Contact: Nazan Degirmenci, Assoc. Prof.; Phone Number: +90(212) 523 22 88; Email: nzndegirmenci@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nigella sativa; 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; A fixed oil obtained from Nigella sativa seeds, administered as ear drops (2 drops twice daily for 10 days).
Active Comparator: mometasone furoate; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to Day 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline to Day 10

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Eczematous Otitis Externa; External Ear Dermatitis; Nigella sativa oil
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; Eczema; Otitis Externa; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienediols; Mometasone Furoate; Nigella sativa oil
• Other Study ID Numbers: BVU-KBB-EKDE-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No