Overview

Topical Erythropoietin Hydrogel in Management of Oral Lichen Planus

Status:
Not yet recruiting

Trial end date:
2024-09-23

Target enrollment:
0

Participant gender:
All

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 lichen planus (OLP)

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Ain Shams University

Treatments:

Epoetin Alfa
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide

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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