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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I experimental | Experimental | Group I: Received a combination of 0.1% hyaluronic acid and 0.2% triamcinolone acetonide. |
|
| Group II | Active Comparator | Was treated exclusively with 0.2% triamcinolone acetonide. |
|
| Group III | Active Comparator | Received only 0.1% hyaluronic acid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetonide triamcinolone 0.2% +hyaluronicacid 1% | Combination Product | topical application cream form twice a day for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain assessment scale | visual analog scale (VAS) score 0-10 higher scores mean a worse outcome. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| OHIP-14 questionnaire | evaluate the oral health related quality of life score 0-56 higher scores mean a worse outcome | 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 |
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Inclusion Criteria:
Patients with diagnosis oral lichen planus. Patients with no history of taking corticosteroids for the last 6 months Patients who agrees to take medication.
Exclusion Criteria:
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,
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pia Lopez Jornet | Murcia | 30004 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37713153 | Result | 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. | |
| 37109100 | Result | Leong 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. |
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| ID | Term |
|---|---|
| D017676 | Lichen Planus, Oral |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D008010 | Lichen Planus |
| D017512 | Lichenoid Eruptions |
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| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| C574257 | lyve1b protein, zebrafish |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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Randomization: The enrolled subjects were randomly assigned to one of two treatment protocols using a computer-generated table. This method ensures impartial allocation and avoids biases in treatment selection for each patient.
Masking: Medications were prepared and packaged in identical, sealed, and numbered envelopes by the hospital pharmacy and a clinician not involved in the subsequent phases of the study. Each sealed envelope contained the protocol assignment for individual patients and written instructions for the application of the medications. Moreover, clinicians involved in treatment evaluation at each follow-up session were blinded to the treatment assigned to each patient.
| Corticoid Acetonide triamcinolone 0.2% | Drug | topical application cream form twice a day for 4 weeks |
|
|
| Hyaluronic acid 1% | Drug | topical application cream form twice a day for 4 weeks |
|
|
| 4 weeks |
| Salivary level of oxidative stress biomarker | Salivary level of oxidative stress biomarker Amilase; Glutation, IgA, FRAP, ADA | 4 weeks |
| D017444 |
| Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |