Trial · NCT06591884
Evaluation of the Efficacy of 0.08% Tacrolimus Nanoencapsulated Aqueous Solution Spray Vs. 0.1% Free Tacrolimus Commercial Ointment in the Treatment of Oral Lichen Planus
NCT06591884, Phase 1, Phase 2, Recruiting, Hospital de Clinicas de Porto Alegre
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of the Efficacy of 0.08% Tacrolimus Nanoencapsulated Aqueous Solution Spray Vs. 0.1% Free Tacrolimus Commercial Ointment in the Treatment of Oral Lichen Planus. Trials, record NCT06591884. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06591884
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of the Efficacy of 0.08% Tacrolimus Nanoencapsulated Aqueous Solution Spray Vs. 0.1% Free Tacrolimus Commercial Ointment in the Treatment of Oral Lichen Planus
- NCT number
- NCT06591884
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 46 participants, estimated
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Conditions
- Oral Erosive Lichen Planus
- Interventions
- Tacrolimus modified-release, tacrolimus ointment 0.1%
- First posted
- 2024-09-19
- Last updated
- 2024-10-02
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Oral Disease Severity Score (ODSS) - 50% | 30 days | Number of patients achieving a reduction of at least 50% in ODSS score compared to baseline and the percentage and absolute reduction in ODSS score in both groups at the end of treatment (30 days). ODSS score ranges from 0 to 106, lower score mean a better outcome. |
| Primary | VAS (visual analogical score) pain score - 50% | 30 days | number of patients achieving a reduction of at least 50% in VAS score of reported pain compared to baseline and the percentage and absolute reduction in VAS score in both groups at the end of treatment (30 days). VAS score ranges from 0 to 10, lower score mean a better outcome. |
| Secondary | OHIP-14 quality of life score | 15-90 days | the percentage and absolute reduction in OHIP-14 scale score in both groups at mid-treatment and end of treatment (15 and 30 days) and at the 30 and 60-day follow-ups after treatment completion (follow-up 1 and follow-up 2). OHIP-14 score ranges from 0 to 56, lower score mean a better outcome. |
| Secondary | Beck scale scores (anxiety levels) | 15-90 days | The percentage and absolute reduction in Beck scale score in both groups at mid-treatment and end of treatment (15 and 30 days) and at the 30 and 60-day follow-ups after treatment completion (follow-up 1 and follow-up 2). OHIP-14 score ranges from 0 to 63, lower score mean a better outcome. |
| Secondary | hedonic scale satisfaction scores | 30-90 days | Comparison of hedonic scale scores of satisfaction reported by the participants in regards of treatment received in both groups at the end of treatment (30 days) and at the 30 and 60-day follow-ups after treatment completion (follow-up 1 and follow-up 2). Hedonic scale satisfaction score ranges from 0 to 9, higher score mean a better outcome. |
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/NCT06591884
GET https://conductscience.org/api/trials/v1/NCT06591884/registered