Clinical trial · Interventional
Topical Erythropoietin Hydrogel in Management of Oral Lichen Planus
Topical Erythropoietin Hydrogel in Management of Oral Lichen Planus: A Randomized Controlled Clinical Trial
NCT06135259CI-TRIAL-00073500unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Lichen Planus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| erythropoietin | Drug | — | UNRESOLVED |
| Triamcinolone acetonide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- erythropoietin mucoadhesive thermosensitive hydrogel
- description
- erythropoietin solutions of 150, 300, and 500 IU/mL were mixed with trimethyl chitosan (M) solutions. glycerophosphate solution was then added to the mixture to obtain erythropoietin-loaded hydrogel comprising final concentrations of trimethyl chitosan (5%) and glycerophosphate (20%).
- interventionNames
- Drug: erythropoietin
- type
- ACTIVE_COMPARATOR
- label
- Triamcinolone Mucoadhesive gel
- description
- Each 0.1 mg triamcinolone acetonide in a dental paste containing gelatin, pectin, cream flavor, vanilla flavor and carboxymethylcellulose sodium in Plasticized Hydrocarbon Gel, a polyethylene and mineral oil gel base.
- interventionNames
- Drug: Triamcinolone acetonide
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 25 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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)
\-References
Publications (0)
Data not yet available
No reference posted for this study.