Trial · NCT03592342
Intra-oral Treatment of OLP With Rivelin®-CLO Patches
NCT03592342, Phase 2, Completed, Dermtreat
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Intra-oral Treatment of OLP With Rivelin®-CLO Patches. Trials, record NCT03592342. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03592342
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intra-oral Treatment of OLP With Rivelin®-CLO Patches
- NCT number
- NCT03592342
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 140 participants, actual
- Lead sponsor
- Dermtreat
- Conditions
- Oral Lichen Planus
- Interventions
- Clobetasol Propionate
- First posted
- 2018-07-19
- Last updated
- 2020-07-14
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in ulcer area | 4 weeks | The change will be calculated from baseline to end of trial |
| Secondary | Change in lesion area | 4 weeks | The change will be calculated from baseline to end of trial |
| Secondary | Change in 5-point erythema score | 4 weeks | The change will be calculated from baseline to end of trial using a 5-point erythema score (assessed as no redness (0) or very severe redness (4)) |
| Secondary | Change in Clinical global impression score | 4 weeks | The change will be calculated from baseline to end of trial using the Clinical Global Impression Score assessed on a 5-point rating scale ranging between no disease (0) and very severe disease (4) |
| Secondary | Change in OLPSSM total score (item #1 to #7) | 4 weeks | The change will be calculated from baseline to end of trial. The OLPSSM (OLP Symptom Severity Measure) is a recently developed questionnaire, which serves for the patient to assess his/her specific OLP symptoms. This questionnaire consists of overall 12 items, to be assessed at different time points. Most items should be completed on a daily basis (in the evening). These items will be assessed as part of the patient's eDiary |
| Secondary | Change in individual diary symptom scores (item #1 to #7 of the OLPSSM) | 4 weeks | The change will be calculated from baseline to end of trial. The OLPSSM (OLP Symptom Severity Measure) is a recently developed questionnaire, which serves for the patient to assess his/her specific OLP symptoms. This questionnaire consists of overall 12 items, to be assessed at different time points. Most items should be completed on a daily basis (in the evening). These items will be assessed as part of the patient's eDiary. |
| Secondary | Change in worst symptoms at anatomical sites | 4 weeks | The change will be calculated from baseline to end of trial |
| Secondary | The proportion of positive outcomes (score 0 or 1) on each of the 11 questions in the Patch Sensation Questionnaire | 2 weeks | The patient will assess the sensation of wearing the Rivelin® patches by answering 11 questions (the Patch sensation questionnaire) according to 5-point rating scales (ranging between 0 \[most positive response\] and 4 \[most negative response\]).The Patch Sensation Questionnaire will be completed during the clinic visit at baseline (visit 2) after first patch application and at visit 4 (2 weeks). |
| Secondary | The proportion of patients with successful (>=80% of days on treatment) patch applications | 4 weeks | Defined as an adhesion time more than 30 minutes during the 4 weeks treatment |
| Secondary | Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | 4 weeks | Frequency and intensity of adverse events (AEs) reported during the study |
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/NCT03592342
GET https://conductscience.org/api/trials/v1/NCT03592342/registered