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Active, Not Recruiting

NCT Number: NCT04364555

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Oral surgery, Universityhospital of Scania, Lund, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clobetasol propionate

Drug

Klobetasol APL oral gel 0.025% is a topical steroid for rinsing the oral cavity. Manufactured by APL, Sweden.

Other names: Klobetasol APL oral gel 0.025%

Placebo/Klobetasol APL oral gel 0.025%

Drug

Placebo/active

Placebo

Drug

Placebo/placebo

Primary outcomes

  1. Clinical appearance of the lichen lesion

    Time frame: Four weeks

    Site-, severity- and activity-score according to Escudier et al

Secondary outcomes

  1. Oral health impact profile

    Time frame: Four weeks

    Oral health impact profile (OHIP-14)

  2. Pain score

    Time frame: Four weeks

    VAS scale. A 10 cm scale ranging from no pain what so ever to worst pain imaginable.

  3. Burning sensation score

    Time frame: Four weeks

    VAS scale. A 10 cm scale ranging from no burning sensation what so ever to worst burning sensation imaginable.

  4. Histological appearance

    Time frame: Four weeks

    Amount and degree of lichenoid reaction in biopsy

  5. Candida

    Time frame: baseline (At treatment start)

    Candida hyphae in smear from lichen lesions

Sponsors and collaborators

Lead sponsor

Malmö University

Other

Collaborators

  • Skane University Hospital
  • University of Copenhagen

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Apr 28, 2020
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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