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

Phase 1

• Conditions: Oral lichen planus; MedDRA version: 20.1Level: PTClassification code 10030983Term: Oral lichen planusSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]

• Registration Number: EUCTR2018-004222-28-SE
• Lead Sponsor: Malmö University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-02
• Last Update Posted: 11 May 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 90

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the treatment effect of mouthwash with clobetasol<br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): Change in OHIP-14<br>Change in Pain score<br>Change in Burning sensation score;Timepoint(s) of evaluation of this end point: At the end of 4 weeks treatment.