Oral Lichen PlanusPhase 2/3NCT04364555
Efficacy of Topical Treatment With Clobetasol in Symptomatic Oral Lichen Planus.
A Phase 2/3 study testing Clobetasol Propionate in people with Oral Lichen Planus, run by Malmö University at 2 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- Clobetasol Propionate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesSweden
- Study dates
- 18 May 2020to Dec 2025
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Symptomatic oral lichen planus
- Age above 40 years
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Oral surgery, Universityhospital of Scania
Lund, 22242
Oral Surgery and oral medicine, Malmö University
Malmö, 20506
About this study
Official title: Efficacy of Topical Treatment With Clobetasol in Symptomatic Oral Lichen Planus. A Multicenter Placebo-controlled Randomized Clinical Trial.
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.
- Conditions
- Oral Lichen Planus
- Being tested
- Clobetasol Propionate, Placebo/Klobetasol APL oral gel 0.025%, Placebo
- Keywords
- Oral lichen planus, Treatment, Candida
- Medical subject headings
- Lichen Planus, Oral, Torulopsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clobetasol PropionateDrug
Also called Klobetasol APL oral gel 0.025%
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%Drug
Placebo/active
PlaceboDrug
Placebo/placebo
| Study group | Role | What they receive |
|---|---|---|
| Active/active | Active comparator | 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. Receives: Drug: Clobetasol Propionate |
| Placebo/active | Active comparator | 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. Receives: Drug: Placebo/Klobetasol APL oral gel 0.025% |
| Placebo/placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical appearance of the lichen lesion
Site-, severity- and activity-score according to Escudier et al
Measured: Four weeks
Secondary outcomes (5)
Oral health impact profile
Oral health impact profile (OHIP-14)
Measured: Four weeks
Pain score
VAS scale. A 10 cm scale ranging from no pain what so ever to worst pain imaginable.
Measured: Four weeks
Burning sensation score
VAS scale. A 10 cm scale ranging from no burning sensation what so ever to worst burning sensation imaginable.
Measured: Four weeks
Histological appearance
Amount and degree of lichenoid reaction in biopsy
Measured: Four weeks
Candida
Candida hyphae in smear from lichen lesions
Measured: baseline (At treatment start)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start18 May 2020
- Primary completion3 Jul 2024
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Malmö University
- Sponsor type
- University, hospital or other
- Collaborators
- Skane University Hospital, University of Copenhagen
- Responsible party
- Principal investigator, Fredrik Gränse, Malmö University
- Investigators
- Bengt Götrick, Docent, Study chair, Malmö University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364555
- Sponsor's protocol ID
- LIKLO-1
- Status last verified
- Nov 2024
- First submitted
- 24 Apr 2020
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Still undecided since we dont know what data to share and how, yet.
Publications
Granse F, Kroona L, Truedsson A, Larsson Wexell C, Gotrick B. Topical clobetasol propionate 0.025% oral gel in the treatment of oral lichen planus: a double-blind, randomized placebo-controlled trial. BMC Oral Health. 2026 May 20;26(1):910. doi: 10.1186/s12903-026-08599-7.
PubMed 42163196
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Topical Treatment With Clobetasol in Symptomatic Oral Lichen Planus. A Multicenter Placebo-controlled Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04364555
- Acronym / sponsor ID
- LIKLO-1
- Conditions
- Oral Lichen Planus
- Keywords
- Oral lichen planus, Treatment, Candida
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Malmö UniversityUniversity, hospital or other
- Collaborators
- Skane University Hospital, University of Copenhagen
- Study start
- 18 May 2020 (actual)
- Primary completion
- 3 Jul 2024 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active/active | Active comparator | Drug: Clobetasol PropionateThe 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. |
| Placebo/active | Active comparator | Drug: Placebo/Klobetasol APL oral gel 0.025%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. |
| Placebo/placebo | Placebo comparator | Drug: PlaceboBoth 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Symptomatic oral lichen planus
- Age above 40 years
Key exclusion criteria (14 listed)
- Lichenoid contact lesions
- Graft versus host disease
- Bacteria related lichenoid reaction
- Intraoral vesiculobullous diseases
- Active antibiotic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clobetasol PropionateAlso: Klobetasol APL oral gel 0.025%Klobetasol APL oral gel 0.025% is a topical steroid for rinsing the oral cavity. Manufactured by APL, Sweden. | Drug | Active/active |
| Placebo/Klobetasol APL oral gel 0.025%Placebo/active | Drug | Placebo/active |
| PlaceboPlacebo/placebo | Drug | Placebo/placebo |
Primary outcome
Clinical appearance of the lichen lesion
Time frame: Four weeks
Site-, severity- and activity-score according to Escudier et al
5 secondary outcomes
Oral health impact profile
Time frame: Four weeks
Pain score
Time frame: Four weeks
Burning sensation score
Time frame: Four weeks
Histological appearance
Time frame: Four weeks
Candida
Time frame: baseline (At treatment start)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Derived from this study: PubMed 42163196Granse F, Kroona L, Truedsson A, Larsson Wexell C, Gotrick B. Topical clobetasol propionate 0.025% oral gel in the treatment of oral lichen planus: a double-blind, randomized placebo-controlled trial. BMC Oral Health. 2026 May 20;26(1):910. doi: 10.1186/s12903-026-08599-7.
- Individual participant dataSharing planned: No. Still undecided since we dont know what data to share and how, yet.
Related trials for Oral Lichen Planus
RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
Not yet recruiting
Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
Oral Lichen Planus
Not yet recruiting
Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
Degree of Adherence of Symptomatic OLP Patients to Their Medications
Active, not recruitingPhase 4
Low Level Laser Therapy With Injectable Platelet Rich Fibrin in Management of Oral Lichen Planus
Oral Lichen Planus
Active, not recruiting
Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
Erythroplakia, Fanconi Anemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bengt Götrick, Docent study chair
Malmö University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Clobetasol Propionate in people with Oral Lichen Planus, run by Malmö University at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical appearance of the lichen lesion (time frame: Four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04364555, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.