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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Oral Leukoplakia
• Intervention / Treatment: Drug: Calcipotriol 0.005% gel; Device: ALA mediated PDT

Detailed Description

Oral leukoplakia (OL) is a prevalent, potentially malignant disorder of the oral mucosa, characterized by white patches that cannot be scraped off and are not attributable to any other definable disease. Affecting a significant portion of the adult population, OL carries a considerable risk of malignant transformation to oral squamous cell carcinoma (OSCC). Current management strategies for OL range from watchful waiting and surgical excision to various topical and systemic pharmacological interventions, all with varying degrees of success and potential side effects. Topical calcipotriol gel helps reverse dysplastic changes (OL) by promoting normal cell differentiation. Photo dynamic therapy using 5- aminolevulonic acid can selectively destroys abnormal cells. Treatment effectiveness can be monitored non-invasively through salivary levels of Matrix metallo proteinases-9 (MMP-9) and Tumor necrosis factor-alpha (TNF-α), biomarkers that reflect disease progression and treatment response.

Aim: Evaluate and compare the effectiveness of topical calcipotriol gel and photodynamic therapy using 5- aminolevulonic acid as a photosensitizer in the regression of OL which will be measured by a clinical score. The impact of these treatment modalities on levels of salivary MMP-9 and TNF-alpha will also be investigated. Materials and Methods: A randomized clinical trial will be carried out on 30 patients diagnosed clinically with OL and histologically confirmed dysplasia. Group I (n=15 patients) will be treated using topical calcipotriol gel 0.005% twice daily for 4 weeks.

Group II (n=15 patients) will be treated by photodynamic therapy using 635nm diode laser and 20% aminolevulonic acid gel. Each point will receive 3 minutes of irradiation at 500 mW/cm2 power density at a dosage of 150 J/cm2. Lesions will be evaluated clinically at baseline,,2,4,8 and 12 weeks using Femiano et al clinical scoring key. Salivary levels of MMP-9 and TNF-α will be evaluated at baseline, 4 and 12 weeks.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21527
    • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: calcipotriol arm; patients recieved topical calcipotriol gel for 4 weeks and assess salivary biomarkers at 0, 4 and 12 weeks later	Drug: Calcipotriol 0.005% gel; using prepared calcipotriol in orabase twice daily for 4 weeks
Active Comparator: photodynamic therapy arm; 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	Device: ALA mediated PDT; applying photodynamic therapy using laser device on photosensitizer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical improvement in oral leseions	measuring reduction in size in cm using periodontal probe or endo ruler before and after treatment	0,4 and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in salivary biomarkers before and after treatment	reduction in level of TNF-alpha and MMP-9 salivary biomarkers before and after treatment by ELISA and corelating it with the clinical outcomes	0,4, and 12 weeks

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Study Chair: Eglal M Moussa, PhD oral medicine, Alexandria University

Publications and helpful links

General Publications

• Ghalwash 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

Helpful Links

• describes results of device in a previous study

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2025
• Primary Completion (Estimated): August 10, 2026
• Study Completion (Estimated): September 10, 2026

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: June 15, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Photodynamic therapy; Laser; calcipotriol; Oral Leukoplakia; Vit D; 5- ALA
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Pathological Conditions, Anatomical; Head and Neck Neoplasms; Precancerous Conditions; Mouth Neoplasms; Pathological Conditions, Signs and Symptoms; Leukoplakia; Leukoplakia, Oral; Pharmaceutical Preparations; Dosage Forms; Complex Mixtures; Colloids; Gels; calcipotriene
• Other Study ID Numbers: Alex-Dent-OMed-Leukoplakia2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: demographoc data including age, sex habits such as smoking preoperative level of Vit D
• IPD Sharing Time Frame: aftrer publication and for 6 months
• IPD Sharing Access Criteria: qualified researchers
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No