Oral Lichen PlanussalivaLichenNCT06332365
Evaluating Treatment Efficacy in Oral Lichen Planus: The Role of Salivary Biomarkers
A study testing Acetonide triamcinolone 0.2% +hyaluronicacid 1%, Corticoid Acetonide triamcinolone 0.2% and Hyaluronic acid 1% in people with Oral Lichen Planus and Oral Lichen Planus Related Stress, run by Pia Lopez Jornet at 1 site in Spain.
Trial summary
Lichen planus, a chronic autoimmune mucocutaneous disorder, affects 0.5% to 2.2% of diverse populations. The treatment for oral lichen planus (OLP) includes a range of options, both topical and systemic therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Lichen Planus, Oral Lichen Planus Related Stress
- What is being tested?
- Acetonide triamcinolone 0.2% +hyaluronicacid 1%, Corticoid Acetonide triamcinolone 0.2% and Hyaluronic acid 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 3 Jan 2022to 19 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diagnosis oral lichen planus. Patients with no history of taking corticosteroids for the last 6 months Patients who agrees to take medication.
Who cannot join
- Pregnant and lactating ladies. Patients with recent dental filling associated with the lesion or associated with recent drug administration.
- Patient with uncontrolled diabetes, uncontrolled hypertension,
Trial locations and contacts
1 site in 1 country.
About this study
Lichen planus, a chronic autoimmune mucocutaneous disorder, affects 0.5% to 2.2% of diverse populations. The treatment for oral lichen planus (OLP) includes a range of options, both topical and systemic therapies. Recent research has highlighted the potential of hyaluronic acid as a drug alternative, potentially offering effective management for OLP and alleviating the discomfort of this chronic condition. The objective was to assess the impact of topical hyaluronic acid on salivary oxidative stress markers in individuals suffering from oral lichen planus
Read the detailed description
Interventional (Clinical Trial) Actual Enrollment : 60 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Care Provider, Outcomes Assessor) Masking Description: The clinical outcomes were assessed by an investigator masked about the treatment modality that has been used Primary Purpose: Treatment Pain , quality of life the study on oral lichen planus, three treatment groups were established:
Group I: Received a combination of 0.1% hyaluronic acid and 0.2% triamcinolone acetonide.
Group II: Was treated solely with 0.2% triamcinolone acetonide. Group III: Received only 0.1% hyaluronic acid. These groups were designed to evaluate and compare the efficacy of different treatments in patients with oral lichen planus.
- Being tested
- Acetonide triamcinolone 0.2% +hyaluronicacid 1%, Corticoid Acetonide triamcinolone 0.2%, Hyaluronic acid 1%
- Keywords
- treatment, saliva stress, oral lichen planus
- Medical subject headings
- Lichen Planus, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetonide triamcinolone 0.2% +hyaluronicacid 1%Combination product
Also called GroupI
topical application cream form twice a day for 4 weeks
Corticoid Acetonide triamcinolone 0.2%Drug
Also called GropupII
topical application cream form twice a day for 4 weeks
Hyaluronic acid 1%Drug
Also called groupIII
topical application cream form twice a day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group I experimental | Experimental | Group I: Received a combination of 0.1% hyaluronic acid and 0.2% triamcinolone acetonide. Receives: Combination Product: Acetonide triamcinolone 0.2% +hyaluronicacid 1% |
| Group II | Active comparator | Was treated exclusively with 0.2% triamcinolone acetonide. Receives: Drug: Corticoid Acetonide triamcinolone 0.2% |
| Group III | Active comparator | Received only 0.1% hyaluronic acid. Receives: Drug: Hyaluronic acid 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment scale
visual analog scale (VAS) score 0-10 higher scores mean a worse outcome.
Measured: 4 weeks
Secondary outcomes (3)
OHIP-14 questionnaire
evaluate the oral health related quality of life score 0-56 higher scores mean a worse outcome
Measured: 4 weeks
reduction of clinical signs measure
Thongprasom Score 5 = white striae with erosive area = 1 cm2 Score 4 = white striae with erosive area < 1 cm2 Score 3 = white striae with erosive area > 1 cm2 Score 2 = white striae with atrophic area < 1 cm2 Score 1 = mild white striae only Score 0 = no lesion normal
Measured: 4 weeks
Salivary level of oxidative stress biomarker
Salivary level of oxidative stress biomarker Amilase; Glutation, IgA, FRAP, ADA
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start3 Jan 2022
- Primary completion15 Dec 2023
- Study completion19 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pia Lopez Jornet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pia Lopez Jornet, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332365
- Sponsor's protocol ID
- ID: 3938/2022
- Acronym
- salivaLichen
- Status last verified
- Feb 2024
- First submitted
- 19 Mar 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Louisy A, Humbert E, Samimi M. Oral Lichen Planus: An Update on Diagnosis and Management. Am J Clin Dermatol. 2024 Jan;25(1):35-53. doi: 10.1007/s40257-023-00814-3. Epub 2023 Sep 15.
PubMed 37713153Leong XY, Gopinath D, Syeed SM, Veettil SK, Shetty NY, Menon RK. Comparative Efficacy and Safety of Interventions for the Treatment of Oral Lichen Planus: A Systematic Review and Network Meta-Analysis. J Clin Med. 2023 Apr 7;12(8):2763. doi: 10.3390/jcm12082763.
PubMed 37109100
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Treatment Efficacy in Oral Lichen Planus: The Role of Salivary Biomarkers
- ClinicalTrials.gov ID
- NCT06332365
- Acronym / sponsor ID
- salivaLichen / ID: 3938/2022
- Keywords
- treatment, saliva stress, oral lichen planus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pia Lopez JornetUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 19 Feb 2024 (actual)
- First posted
- 27 Mar 2024 (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.
Lichen planus, a chronic autoimmune mucocutaneous disorder, affects 0.5% to 2.2% of diverse populations. The treatment for oral lichen planus (OLP) includes a range of options, both topical and systemic therapies. Recent research has highlighted the potential of hyaluronic acid as a drug alternative, potentially offering effective management for OLP and alleviating the discomfort of this chronic condition. The objective was to assess the impact of topical hyaluronic acid on salivary oxidative stress markers in individuals suffering from oral lichen planus
Detailed description
Interventional (Clinical Trial) Actual Enrollment : 60 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Care Provider, Outcomes Assessor) Masking Description: The clinical outcomes were assessed by an investigator masked about the treatment modality that has been used Primary Purpose: Treatment Pain , quality of life the study on oral lichen planus, three treatment groups were established:
Group I: Received a combination of 0.1% hyaluronic acid and 0.2% triamcinolone acetonide.
Group II: Was treated solely with 0.2% triamcinolone acetonide. Group III: Received only 0.1% hyaluronic acid. These groups were designed to evaluate and compare the efficacy of different treatments in patients with oral lichen planus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I experimental | Experimental | Combination Product: Acetonide triamcinolone 0.2% +hyaluronicacid 1%Group I: Received a combination of 0.1% hyaluronic acid and 0.2% triamcinolone acetonide. |
| Group II | Active comparator | Drug: Corticoid Acetonide triamcinolone 0.2%Was treated exclusively with 0.2% triamcinolone acetonide. |
| Group III | Active comparator | Drug: Hyaluronic acid 1%Received only 0.1% hyaluronic acid. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with diagnosis oral lichen planus. Patients with no history of taking corticosteroids for the last 6 months Patients who agrees to take medication.
Key exclusion criteria (2 listed)
- Pregnant and lactating ladies. Patients with recent dental filling associated with the lesion or associated with recent drug administration.
- Patient with uncontrolled diabetes, uncontrolled hypertension,
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 |
|---|---|---|
| Acetonide triamcinolone 0.2% +hyaluronicacid 1%Also: GroupItopical application cream form twice a day for 4 weeks | Combination product | Group I experimental |
| Corticoid Acetonide triamcinolone 0.2%Also: GropupIItopical application cream form twice a day for 4 weeks | Drug | Group II |
| Hyaluronic acid 1%Also: groupIIItopical application cream form twice a day for 4 weeks | Drug | Group III |
Primary outcome
Pain assessment scale
Time frame: 4 weeks
visual analog scale (VAS) score 0-10 higher scores mean a worse outcome.
3 secondary outcomes
OHIP-14 questionnaire
Time frame: 4 weeks
reduction of clinical signs measure
Time frame: 4 weeks
Salivary level of oxidative stress biomarker
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Results publication: PubMed 37713153Louisy A, Humbert E, Samimi M. Oral Lichen Planus: An Update on Diagnosis and Management. Am J Clin Dermatol. 2024 Jan;25(1):35-53. doi: 10.1007/s40257-023-00814-3. Epub 2023 Sep 15.
- Results publication: PubMed 37109100Leong XY, Gopinath D, Syeed SM, Veettil SK, Shetty NY, Menon RK. Comparative Efficacy and Safety of Interventions for the Treatment of Oral Lichen Planus: A Systematic Review and Network Meta-Analysis. J Clin Med. 2023 Apr 7;12(8):2763. doi: 10.3390/jcm12082763.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetonide triamcinolone 0.2% +hyaluronicacid 1%, Corticoid Acetonide triamcinolone 0.2% and Hyaluronic acid 1% in people with Oral Lichen Planus and Oral Lichen Planus Related Stress, run by Pia Lopez Jornet at 1 site in Spain.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain assessment scale (time frame: 4 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 NCT06332365, which also lists 2 linked publications.
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 27 Mar 2024.