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

Primary Purpose

Oral Lichen Planus

Status
Recruiting
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Clobetasol Propionate
Placebo/Klobetasol APL oral gel 0.025%
Placebo
Sponsored by
Malmö University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Lichen Planus focused on measuring Oral lichen planus, Treatment, Candida

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Oral surgery, Universityhospital of ScaniaRecruiting
  • Oral Surgery and oral medicine, Malmö UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Active/active

Placebo/active

Placebo/placebo

Arm Description

The one bottle for use in the morning has clobetasol-oral gel, and so does the bottle fore use in the evening. The oral cavity will be rinsed with 5ml oral gel during 1 minute. Nystatin will be taken 1ml 4 times daily.

The bottle for use in the morning contains placebo and one for use in the evening contains clobetasol oral gel. The oral cavity will be rinsed with 5ml oral gel during 1 minute. Nystatin will be taken 1ml 4 times daily.

Both bottles, the one for the morning and the one for use in the evening, contains placebo. The oral cavity will be rinsed with 5ml oral gel during 1 minute. Nystatin will be taken 1ml 4 times daily.

Outcomes

Primary Outcome Measures

Clinical appearance of the lichen lesion
Site-, severity- and activity-score according to Escudier et al

Secondary Outcome Measures

Oral health impact profile
Oral health impact profile (OHIP-14)
Pain score
VAS scale. A 10 cm scale ranging from no pain what so ever to worst pain imaginable.
Burning sensation score
VAS scale. A 10 cm scale ranging from no burning sensation what so ever to worst burning sensation imaginable.
Histological appearance
Amount and degree of lichenoid reaction in biopsy
Candida
Candida hyphae in smear from lichen lesions

Full Information

First Posted
April 24, 2020
Last Updated
July 28, 2023
Sponsor
Malmö University
Collaborators
Skane University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04364555
Brief Title
Efficacy of Topical Treatment With Clobetasol in Symptomatic Oral Lichen Planus.
Official Title
Efficacy of Topical Treatment With Clobetasol in Symptomatic Oral Lichen Planus. A Multicenter Placebo-controlled Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2020 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Malmö University
Collaborators
Skane University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Lichen Planus
Keywords
Oral lichen planus, Treatment, Candida

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active/active
Arm Type
Active Comparator
Arm Description
The one bottle for use in the morning has clobetasol-oral gel, and so does the bottle fore use in the evening. The oral cavity will be rinsed with 5ml oral gel during 1 minute. Nystatin will be taken 1ml 4 times daily.
Arm Title
Placebo/active
Arm Type
Active Comparator
Arm Description
The bottle for use in the morning contains placebo and one for use in the evening contains clobetasol oral gel. The oral cavity will be rinsed with 5ml oral gel during 1 minute. Nystatin will be taken 1ml 4 times daily.
Arm Title
Placebo/placebo
Arm Type
Placebo Comparator
Arm Description
Both bottles, the one for the morning and the one for use in the evening, contains placebo. The oral cavity will be rinsed with 5ml oral gel during 1 minute. Nystatin will be taken 1ml 4 times daily.
Intervention Type
Drug
Intervention Name(s)
Clobetasol Propionate
Other Intervention Name(s)
Klobetasol APL oral gel 0.025%
Intervention Description
Klobetasol APL oral gel 0.025% is a topical steroid for rinsing the oral cavity. Manufactured by APL, Sweden.
Intervention Type
Drug
Intervention Name(s)
Placebo/Klobetasol APL oral gel 0.025%
Intervention Description
Placebo/active
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo/placebo
Primary Outcome Measure Information:
Title
Clinical appearance of the lichen lesion
Description
Site-, severity- and activity-score according to Escudier et al
Time Frame
Four weeks
Secondary Outcome Measure Information:
Title
Oral health impact profile
Description
Oral health impact profile (OHIP-14)
Time Frame
Four weeks
Title
Pain score
Description
VAS scale. A 10 cm scale ranging from no pain what so ever to worst pain imaginable.
Time Frame
Four weeks
Title
Burning sensation score
Description
VAS scale. A 10 cm scale ranging from no burning sensation what so ever to worst burning sensation imaginable.
Time Frame
Four weeks
Title
Histological appearance
Description
Amount and degree of lichenoid reaction in biopsy
Time Frame
Four weeks
Title
Candida
Description
Candida hyphae in smear from lichen lesions
Time Frame
baseline (At treatment start)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fredrik Gränse, DDS
Phone
0046736954499
Email
fredrik.granse@mau.se
First Name & Middle Initial & Last Name or Official Title & Degree
Bengt Götrick, Docent
Phone
0046406658427
Email
bengt.gotrick@mau.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bengt Götrick, Docent
Organizational Affiliation
Malmö University
Official's Role
Study Chair
Facility Information:
Facility Name
Oral surgery, Universityhospital of Scania
City
Lund
ZIP/Postal Code
22242
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fredrik Gränse, Phd student
Phone
0046406658432
Email
fredrik.granse@mau.se
First Name & Middle Initial & Last Name & Degree
Cecilia Wexell, Docent
Phone
004646174320
Email
cecilia.wexell@skane.se
Facility Name
Oral Surgery and oral medicine, Malmö University
City
Malmö
ZIP/Postal Code
20506
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fredrik Gränse, Phd student
Phone
0046406658432
Email
fredrik.granse@mau.se
First Name & Middle Initial & Last Name & Degree
Bengt Götrick, Docent
Phone
0046406658427
Email
bengt.gotrick@mau.se

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Still undecided since we dont know what data to share and how, yet.

Learn more about this trial

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

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