Trial · NCT07453472
Comparison of Topical Photodynamic Therapy With Topical Calcipotriol in Management of Oral Leukoplakia
NCT07453472, Phase 3, Not yet recruiting, Dr. Shalini Gupta
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison of Topical Photodynamic Therapy With Topical Calcipotriol in Management of Oral Leukoplakia. Trials, record NCT07453472. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07453472
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Topical Photodynamic Therapy With Topical Calcipotriol in Management of Oral Leukoplakia
- NCT number
- NCT07453472
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 166 participants, estimated
- Lead sponsor
- Dr. Shalini Gupta
- Conditions
- Oral Leukoplakia
- Interventions
Non-invasive Photo Dynamic Therapy using LED of wavelength ranging from 630-660nm( Fluence 15 J/cm2) as light source and 2.5% TB as photosensitizer, Topical application of Calcipotriol ointment 0.005% twice a day for 4 weeks along with preventive and conventional therapy, Conventional non-invasive management : All subjects in the two groups will receive the same standard conventional non- invasive management advised for OL as per current scientific evidence
- First posted
- 2026-03-06
- Last updated
- 2026-03-06
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical response: Number of patients with Complete response/ Partial response/ No response/ alteration in clinical pattern | Baseline, 4 weeks, 12 weeks | a. Clinical response(Chen et al 2021)(42): 1. complete remission of the lesion clinically evaluated; Complete Response CR 2. partial reduction of at least 20% in the total diameter of the lesion; Partial response PR 3. reduction of the lesion by less than 20% in diameter; No Response NR 4. alteration in the clinical pattern of the lesion (homogeneous and non- homogeneous). |
| Secondary | Lesion size | Baseline, 4 weeks, 12 weeks | (bidimensional measurement in cm and area in cm2 ) using Image J software |
| Secondary | Lesion roughness/ whiteness: Number of patients with total resolution/ Moderate resolution/ Minimal change/ No visible change | Baseline, 4 weeks, 12 weeks | Lesion roughness/ whiteness score (Femanio et al 2001)(68): 0: Total resolution of lesions 1. Moderate resolution= reduction of consistency with leveling of the lesion 2. Minimal change= reduction of consistency without leveling of the lesion 3. No visible change |
| Secondary | Oral Health quality of Life: Number of patients with OHIP-14 scores 0-8 | baseline, 4 weeks, 12 weeks | Assessment of oral health quality of life using Oral Health Impact Profile -14 questionnaire: (Score 0-8) |
| Secondary | Concentration of salivary molecular markers ( IL6, TNF-α, PCNA, Survivin and VEGF) | Baseline, 4 weeks | Estimation of concentration of salivary molecular markers ( IL6, TNF-α, PCNA, Survivin and VEGF) by ELISA after completion of treatment at 4 weeks from baseline |
| Other | time to complete response | up to 12 weeks | The time required from baseline for complete response in both groups |
| Other | Oral pain/ burning sensation scores 0-10 | upto 4 weeks | Oral pain/ burning sensation assessment using The numeric rating scale (NRS) from 0-10 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07453472
GET https://conductscience.org/api/trials/v1/NCT07453472/registered