Clinical study to assess the efficacy of Clobetasol mouth rinses in patients with oral lichen planus.

Efficacy of topical treatment with clobetasol in symptomatic oral lichen planus. A multicenter placebo-controlled randomized clinical trial.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004222-28-SE

Enrollment

Registered

2020-01-02

Start date

2020-03-23

Completion date

Unknown

Last updated

2020-05-11

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

Conditions

Oral lichen planus MedDRA version: 20.1 Level: PT Classification code 10030983 Term: Oral lichen planus System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: Klobetasol APL Munhålegel 0,025% Product Name: Klobetasol APL Munhålegel 0,025% Product Code: A01AC Pharmaceutical Form: Mouthwash Pharmaceutical form of the placebo: Oromucosal gel Route

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Symptomatic Oral lichen planus. 2. Age > 40 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: 1. Lichenoid contact reactions. 2. Graft versus host disease. 3. Plaque-associated lichenoid reaction. 4. Intraoral diseases with blisters. 5. Ongoing treatment with antibiotics. 6. Ongoing treatment with cortisone or other immunomodulatory drug. 7. Hypersensitivity to clobetasol propionate. 8. Severe periodontitis, as defined by Papapanou et al 2018 (4): CAL > 5 mm, probing depth> 6 mm, furcation involvement 2 and 3. 9. Poor oral hygiene (plaque index [according to Silness-Löe]> 2). 10. Oral lichen planus not verified by biopsy. 11. Hypersensitivity to nystatin. 12. Not reached menopaus. 13. Ongoing or previosly intraoral malignancy. 14. Ongoing participation in another drug study.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the treatment effect of mouthwash with clobetasol compared to placebo in symptomatic oral lichen planus.;Secondary Objective: To investigate the presence of candida in lichen lesions.;Primary end point(s): Change in lesion Activity score;Timepoint(s) of evaluation of this end point: At the end of 4 weeks treatment.	—

Secondary

Measure	Time frame
Secondary end point(s): Change in OHIP-14 Change in Pain score Change in Burning sensation score;Timepoint(s) of evaluation of this end point: At the end of 4 weeks treatment.	—

Countries

Sweden

Contacts

Public ContactFredrik Gränse

Malmö University

fredrik.granse@mau.se+46406658432

Outcome results

None listed

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