Topical Calcipotriol Versus Photodynamic Therapy in the Treatment of Oral Leukoplakia

NCT07658508 | Active Not Recruiting Phase 2

• 1 other identifier: Alex-Dent-OMed-Leukoplakia2026
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Oral Leukoplakia

Keywords

Oral Leukoplakia; calcipotriol; Laser; Vit D; Photodynamic therapy; 5- ALA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• changes in salivary biomarkers before and after treatment

  0,4, and 12 weeks

Study Arms (2)

calcipotriol arm

ACTIVE COMPARATOR

patients recieved topical calcipotriol gel for 4 weeks and assess salivary biomarkers at 0, 4 and 12 weeks later

Drug: Calcipotriol 0.005% gel

photodynamic therapy arm

ACTIVE COMPARATOR

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

Interventions

Calcipotriol 0.005% gel DRUG

using prepared calcipotriol in orabase twice daily for 4 weeks

calcipotriol arm

ALA mediated PDT DEVICE

applying photodynamic therapy using laser device on photosensitizer

photodynamic therapy arm

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21527, Egypt

Location

Related Publications (1)

• 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

  BACKGROUND

Related Links

• describes results of device in a previous study

MeSH Terms

Conditions

Leukoplakia, Oral

Interventions

calcipotriene; Gels

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Leukoplakia; Precancerous Conditions; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Eglal M Moussa, PhD oral medicine

  Alexandria University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of oral medicine and periodontology

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 22, 2026
• Study Start: July 16, 2025
• Primary Completion (Estimated): August 10, 2026
• Study Completion (Estimated): September 10, 2026
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: aftrer publication and for 6 months
• Access Criteria: qualified researchers

Locations

EG (1)