Clinical trial

Evaluating Treatment Efficacy in Oral Lichen Planus: The Role of Salivary Biomarkers

Name
ID: 3938/2022
Description
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
Trial arms
Trial start
2022-01-03
Estimated PCD
2023-12-15
Trial end
2024-02-19
Status
Completed
Treatment
Acetonide triamcinolone 0.2% +hyaluronicacid 1%
topical application cream form twice a day for 4 weeks
Arms:
Group I experimental
Other names:
GroupI
Corticoid Acetonide triamcinolone 0.2%
topical application cream form twice a day for 4 weeks
Arms:
Group II
Other names:
GropupII
Hyaluronic acid 1%
topical application cream form twice a day for 4 weeks
Arms:
Group III
Other names:
groupIII
Size
60
Primary endpoint
Pain assessment scale
4 weeks
Eligibility criteria
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,
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': '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.\n\nMasking: 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.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2024-03-27

1 organization

3 products

1 indication

Organization
Pia Lopez Jornet