Oral LeukoplakiaPhase 2/3NCT07658508
Topical Calcipotriol Versus Photodynamic Therapy in the Treatment of Oral Leukoplakia
A Phase 2/3 study testing Calcipotriol 0.005% gel and ALA mediated PDT in people with Oral Leukoplakia, run by Alexandria University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Oral Leukoplakia
- What is being tested?
- Calcipotriol 0.005% gel and ALA mediated PDT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jul 2025to 10 Sep 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Oral Leukoplakia
- Being tested
- Calcipotriol 0.005% gel, ALA mediated PDT
- Keywords
- Oral Leukoplakia, calcipotriol, Laser, Vit D, Photodynamic therapy, 5- ALA
- Medical subject headings
- Leukoplakia, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcipotriol 0.005% gelDrug
using prepared calcipotriol in orabase twice daily for 4 weeks
ALA mediated PDTDevice
applying photodynamic therapy using laser device on photosensitizer
| Study group | Role | What they receive |
|---|---|---|
| calcipotriol arm | Active comparator | patients recieved topical calcipotriol gel for 4 weeks and assess salivary biomarkers at 0, 4 and 12 weeks later Receives: 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 Receives: Device: ALA mediated PDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical improvement in oral leseions
measuring reduction in size in cm using periodontal probe or endo ruler before and after treatment
Measured: 0,4 and 12 weeks
Secondary outcomes (1)
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
Measured: 0,4, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start16 Jul 2025
- Primary completion10 Aug 2026 (estimated)
- Study completion10 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral LeukoplakiaStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farida Reayd, Alexandria University
- Investigators
- Eglal M Moussa, PhD oral medicine, Study chair, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07658508
- Sponsor's protocol ID
- Alex-Dent-OMed-Leukoplakia2026
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: demographoc data including age, sex habits such as smoking preoperative level of Vit D
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Calcipotriol Gel Versus Photodynamic Therapy in the Treatment of Oral Leukoplakia: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07658508
- Acronym / sponsor ID
- Alex-Dent-OMed-Leukoplakia2026
- Conditions
- Oral Leukoplakia
- Keywords
- Oral Leukoplakia, calcipotriol, Laser, Vit D, Photodynamic therapy, 5- ALA
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- 10 Aug 2026 (estimated)
- Study completion
- 10 Sep 2026 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| calcipotriol arm | Active comparator | Drug: Calcipotriol 0.005% gelpatients recieved topical calcipotriol gel for 4 weeks and assess salivary biomarkers at 0, 4 and 12 weeks later |
| photodynamic therapy arm | Active comparator | Device: ALA mediated PDTpatients will recieve 4 sessions of 5 aminolevulonic acid mediated photodynamic therapy over 4 weeks and assess salivary biomarkers at 0 , 4 and 12 weeks |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcipotriol 0.005% gelusing prepared calcipotriol in orabase twice daily for 4 weeks | Drug | calcipotriol arm |
| ALA mediated PDTapplying photodynamic therapy using laser device on photosensitizer | Device | photodynamic therapy arm |
Primary outcome
clinical improvement in oral leseions
Time frame: 0,4 and 12 weeks
measuring reduction in size in cm using periodontal probe or endo ruler before and after treatment
1 secondary outcome
changes in salivary biomarkers before and after treatment
Time frame: 0,4, and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- 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
- describes results of device in a previous studyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. demographoc data including age, sex habits such as smoking preoperative level of Vit D
Related trials for Oral Leukoplakia
RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
Active, not recruitingPhase 2
Metformin for the Prevention of Oral Cancer in Patients With Oral Leukoplakia or Erythroplakia
Erythroplakia, Oral Leukoplakia
Active, not recruiting
Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
Erythroplakia, Fanconi Anemia
RecruitingPhase 2
Pembrolizumab in Treating Participants With Leukoplakia
Erythroleukoplakia, Leukoplakia
RecruitingPhase 2
Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia
Oral Leukoplakia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eglal M Moussa, PhD oral medicine study chair
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Calcipotriol 0.005% gel and ALA mediated PDT in people with Oral Leukoplakia, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical improvement in oral leseions (time frame: 0,4 and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07658508, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.