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Light therapy vs. vitamin d cream: new hope for oral cancer prevention?

NCT ID NCT07453472

Disease control Sponsor: Dr. Shalini Gupta 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 two non-surgical treatments for oral leukoplakia, a white patch in the mouth that can turn into cancer. One treatment uses a light-activated dye (photodynamic therapy) and the other uses a vitamin D-based cream (calcipotriol). The goal is to see which works better at shrinking or removing the patches and improving quality of life. About 166 adults with oral leukoplakia will take part, and the results will help find safer, easier ways to manage this condition.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 166 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Mar 2029

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

18 to 99 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: * All diagnosed cases of Oral Leukoplakia with size ≥ 2 cm2 (Van der Waal classification ≥ L2) reporting to the department of OMR, CDER and willing to participate in the study will be included * Subjects clinically and histologically diagnosed as Oral Leukoplakia. * Subjects \> 18 years of age. * Subjects willing to participate in the study and to complete the treatment sessions. Exclusion Criteria: * History of any topical and/or systemic therapy for Oral Leukoplakia other than general management in last 2 months. * Subjects with current or past history of malignancy. * Subjects with any lesion suspicious of malignancy requiring biopsy. * Subjects with severe dysplasia and carcinoma in situ on biopsy of oral lesion * Subjects with history of hyperphotosensitivity (genetic disorders, dermatological conditions, drug induced, systemic conditions) * Subjects with calcium, Vit D metabolic and parathyroid disorders * Pregnant and lactating females.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • All India Institute of Medical Sciences New Delhi

    New Delhi, National Capital Territory of Delhi, 110029, India

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