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Investigating the effect of dexamethasone and fluconazole mouthwash on oral lichen planus

Investigating the therapeutic effect of formulated mouthwash containing dexamethasone and fluconazole on oral lichen planus

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250715066509N1
Enrollment
70
Registered
2025-08-18
Start date
2025-09-23
Completion date
Unknown
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral lichenplanus. Diseases of the skin and subcutaneous tissue, Papulosquamous disorders

Interventions

Intervention 1: 5 ml of a mouthwash formulated with dexamethasone 0.1 mg/ml + fluconazole 2 mg/ml, 3 times a day for 3 weeks. Intervention 2: Control group: Mix a 0.5 mg tablet with 30 drops of nystat

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Adults over 18 and under 65 years of age People who are prescribed mouthwash due to the number or extent of pathological lesions, as approved by a specialist, and the severity of the lesions is equal to two or more according to the Thongprsom criteria. Those who have informed consent to participate in the study

Exclusion criteria

Exclusion criteria: Severe problems due to systemic diseases (more than two according to the ASA classification). People who are unable to rinse their mouth with topical corticosteroids due to systemic or medication reasons. People who have severe dysplasia based on the pathology results People who, for whatever reason, do not wish to continue participating in the project. People who have allergies to the drug or a history of allergies to other components of the formulation. Topical and systemic use of corticosteroid medications in the last 3 weeks Pregnant and breastfeeding women Immunocompromised patients

Design outcomes

Primary

MeasureTime frame
Severity of oral lichen planus lesions. Timepoint: At the beginning of the study /1 week/2 weeks/3 weeks. Method of measurement: Thongprosam.;Pain and burning. Timepoint: At the beginning of the study /1 week/2 weeks/3 weeks. Method of measurement: Visual Analogue Scale (VAS).

Secondary

MeasureTime frame
Treatment Satisfaction. Timepoint: End of the third week. Method of measurement: Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Ehsan Jannatabadi

Mashhad University of Medical Sciences

jannatabadiE4031@mums.ac.ir+98 51 3882 9501

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026