Status:
UNKNOWN
Topical Erythropoietin Hydrogel in Management of Oral Lichen Planus
Lead Sponsor:
Ain Shams University
Conditions:
Oral Lichen Planus
Eligibility:
All Genders
25-60 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the clinical efficacy of erythropoietin gel containing a solution of 4000 units with triamcinolone acetonide 0.1% gel in the treatment of symptomatic oral liche...
Detailed Description
At the first visit before the initiation of the study; * Information including age, gender, disease process, medical history, drug history, family history, and clinical symptoms and signs will be doc...
Eligibility Criteria
Inclusion
- 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)
- Histopathological proven symptomatic OLP
Exclusion
- History of the drug-induced lichenoid lesion.
- 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
- Smoking
- Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation as mentioned in history
- Pregnancy or breastfeeding.
- 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
- Loss of pliability or flexibility in the tissues involved by the lesions of OLP.
- Histological signs of epithelial dysplasia or lichenoid lesions within the biopsied sites.
- Patients with extensive skin lesions and indicated for systemic corticosteroids.
- Vulnerable groups (Handicapped, orphans, or prisoners)
- \-
Key Trial Info
Start Date :
May 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 23 2024
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06135259
Start Date
May 20 2024
End Date
September 23 2024
Last Update
February 1 2024
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