Clinical trial · Interventional
Topical Calcipotriol Versus Photodynamic Therapy in the Treatment of Oral Leukoplakia
Topical Calcipotriol Gel Versus Photodynamic Therapy in the Treatment of Oral Leukoplakia: Randomized Clinical Trial
- 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 goal of this clinical trial is to learn if calcipotriol and photodynamic therapy are equally effective in treatment of leukoplakia or not. The main questions it aims to answer are: do lesions decrease or disappear when treated by calcipotriol or PDT? does the drug affect the salivary biomarkers Participants will: Take calcipotriol daily for 4 weeks or perform 4 PDT sessions over 4 weeks measure changes in salivary biomarkers be followed up for 3 months
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 Leukoplakia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ALA mediated PDT | Device | — | UNRESOLVED |
| Calcipotriol 0.005% gel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- calcipotriol arm
- description
- patients recieved topical calcipotriol gel for 4 weeks and assess salivary biomarkers at 0, 4 and 12 weeks later
- interventionNames
- Drug: Calcipotriol 0.005% gel
- type
- ACTIVE_COMPARATOR
- label
- photodynamic therapy arm
- description
- patients will recieve 4 sessions of 5 aminolevulonic acid mediated photodynamic therapy over 4 weeks and assess salivary biomarkers at 0 , 4 and 12 weeks
- interventionNames
- Device: ALA mediated PDT
Primary outcomes (1)
- measure
- clinical improvement in oral leseions
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 25 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Patients, both males and females, 25 to 55years old will be included in this clinical trial. * Patients with oral leukoplakia with histologically confirmed mild and moderate epithelial dysplasia. * Patients willing and able to return for multiple follow up visits Exclusion Criteria: * Presence of any visible oral lesions other than leukoplakia. * Periodontitis patients: since chronic periodontitis may affect salivary TNF-alpha and MMP-9 level. * Contraindications for the use of calcipotriol or amino levulonic acid as allergy. * History of topical and/or systemic therapy for 2 months before the start of study. * Patients with conditions that could affect saliva collection as xerostomia.
References
Publications (1)
- BACKGROUNDGhalwash D, Mahmoud E, Shaker O. Evaluation Of The Therapeutic Effect Of Topical Calcipotriol Versus Topical Tretinoin In Treatment Of Oral Leukoplakia And Their Effect On Clinical Improvement And Salivary Level Of Mmp-9, Il-6 And Tgf- Β: A Randomized Clinical Trial. Dentistry. 2017 Jan 1