Efficacy of Topical Treatment With Clobetasol in Symptomatic Oral Lichen Planus.

Oral Lichen Planus Clinical Trial

Official title:

Efficacy of Topical Treatment With Clobetasol in Symptomatic Oral Lichen Planus. A Multicenter Placebo-controlled Randomized Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04364555
• Other study ID #: LIKLO-1
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: May 18, 2020
• Est. completion date: August 2024

Study information

• Verified date: July 2023
• Source: Malmö University
• Contact: Fredrik Gränse, DDS
• Phone: 0046736954499
• Email: fredrik.granse[@]mau.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators want to study the effect of clobetasol in symptomatic oral lichen planus. The investigators will include 90 patients and randomly allocate them in three groups. The first group will receive active treatment both in the morning an evening. Group two receives placebo in the morning and active treatment in the evening. Group three will get placebo both in the morning and in the evening. All Groups will follow the same protocol with rinsing twice daily with test substance in conjunction with antifungal treatment. The patients will be controlled after two weeks and and again after another two weeks. A biopsy will be performed at inclusion and another biopsy will be taken at the end of the test period. Smears for candida will also be evaluated. The patients will be examined for changes in clinical appearance and will answer questions to note changes in symptoms. Our hypotheses: #Patients receiving clobetasol will have a better resolution af symptoms than those who got placebo. #Patients treated with clobetasol twice daily will have a faster relief of symptoms than patients just treated once daily. #The clinical signs of oral lichen planus will diminish more pronounced in the two groups given active treatment. #A majority of the OLP lesions were infected by candida. #Specific histological changes can be seen in the biopsies taken after clobetasol treatment compared to those taken before treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Symptomatic oral lichen planus
• Age above 40 years

Exclusion Criteria:

• Lichenoid contact lesions
• Graft versus host disease
• Bacteria related lichenoid reaction
• Intraoral vesiculobullous diseases
• Active antibiotic treatment
• Active treatment with steroids or other immunomodulating substance
• Allergy to Clobetasol
• Severe periodontitis
• Bad oral hygiene
• Biopsy not supporting OLP
• Allergy to nystatin
• Not in menopause
• Previous or actual oral malignancy
• Participation in other medical study

Related Conditions & MeSH terms

• Lichen Planus
• Lichen Planus, Oral
• Oral Lichen Planus

Intervention

Drug:
• Clobetasol Propionate
Klobetasol APL oral gel 0.025% is a topical steroid for rinsing the oral cavity. Manufactured by APL, Sweden.
• Placebo/Klobetasol APL oral gel 0.025%
Placebo/active
• Placebo
Placebo/placebo

Locations

Country	Name	City	State
Sweden	Oral surgery, Universityhospital of Scania	Lund
Sweden	Oral Surgery and oral medicine, Malmö University	Malmö

Sponsors (2)

Lead Sponsor	Collaborator
Malmö University	Skane University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical appearance of the lichen lesion	Site-, severity- and activity-score according to Escudier et al	Four weeks
Secondary	Oral health impact profile	Oral health impact profile (OHIP-14)	Four weeks
Secondary	Pain score	VAS scale. A 10 cm scale ranging from no pain what so ever to worst pain imaginable.	Four weeks
Secondary	Burning sensation score	VAS scale. A 10 cm scale ranging from no burning sensation what so ever to worst burning sensation imaginable.	Four weeks
Secondary	Histological appearance	Amount and degree of lichenoid reaction in biopsy	Four weeks
Secondary	Candida	Candida hyphae in smear from lichen lesions	baseline (At treatment start)