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Can a vitamin d gel or light therapy stop precancerous mouth lesions?

NCT ID NCT07658508

Disease control Sponsor: Alexandria University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a vitamin D-based gel (calcipotriol) or a light-activated treatment (photodynamic therapy) can shrink or eliminate oral leukoplakia, a precancerous condition. Thirty adults with mild to moderate dysplasia will receive one of the two treatments for four weeks and be monitored for three months. Researchers will also check if the treatments reduce certain inflammatory markers in saliva.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
calcipotriol gel and photodynamic therapy
What this could lead to
If it works, this could point toward a non-surgical treatment for oral leukoplakia, potentially lowering the risk of oral cancer.
What could go wrong
This is a small, early-phase trial with only 30 people, so results may not apply to everyone. The treatments might not shrink lesions or could cause side effects like irritation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

30 people

The number who actually took part.

Started

Jul 2025

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

25 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

oral mucosa leukoplakia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Oral leukoplakia

Contacts and locations

Locations

  • Faculty of Dentistry, Alexandria University

    Alexandria, 21527, Egypt

More trials for these conditions

Other studies related to the condition(s) this trial covers.