Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2025-12-24 @ 2:23 PM
NCT ID:
NCT06135259
Eligibility Criteria:
Inclusion Criteria:
1. Clinically proven painful symptomatic forms of OLP confirmed by the presence of red or erythematous changes, or shallow ulcerations with fine lacy lines at the periphery of the lesion accentuated by stretching and not eliminated by rubbing (Wickham's striae)
2. Histopathological proven symptomatic OLP
Exclusion Criteria:
1. History of the drug-induced lichenoid lesion.
2. Presence of systemic conditions as; serious active or recurrent infections, malignancy, diabetes mellitus, hypertension, or significant heart, liver, or renal diseases. Assessed using a medical questionnaire guided by the Cornell Medical Index
3. Smoking
4. Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation as mentioned in history
5. Pregnancy or breastfeeding.
6. History of previous treatments potentially effective on OLP such as antimalarial agents, retinoids, corticosteroids, or immunosuppressive drugs from less than 2 weeks for topical medications, and 4 weeks for systemic medications before starting the study
7. Loss of pliability or flexibility in the tissues involved by the lesions of OLP.
8. Histological signs of epithelial dysplasia or lichenoid lesions within the biopsied sites.
9. Patients with extensive skin lesions and indicated for systemic corticosteroids.
10. Vulnerable groups (Handicapped, orphans, or prisoners)
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
60 Years
Study:
NCT06135259
Study Brief:
Protocol Section:
NCT06135259