Trial · NCT00297037
Pimecrolimus Cream for Oral Lichen Planus
NCT00297037, Phase 2, Completed, University of Utah; results first posted 2012-10-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pimecrolimus Cream for Oral Lichen Planus. Trials, record NCT00297037. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00297037
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pimecrolimus Cream for Oral Lichen Planus
- NCT number
- NCT00297037
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- University of Utah
- Conditions
- Oral Lichen Planus
- Interventions
- Pimecrolimus 1% cream
- First posted
- 2006-02-27
- Last updated
- 2012-10-17
- Results first posted
- 2012-10-17
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Primary Efficacy Variable Was the Change in the Investigator's Global Assessment of the Overall Severity of Disease From Baseline to Week 6. | 0, 1, 2, 4, 6 weeks | The primary efficacy variable was the change in the Investigator's Global Assessment of the overall severity of disease from baseline to week 6. Scale is 0-4. 0 is no disease. 4 is worst disease. Minimum score is 0. Maximum score is 4. Measurments were completed day 0, week 1, week 2, week 4, and week 6. Scores are listed at baseline (day 0) and end of study (week 6). |
| Secondary | The Secondary Efficacy Variables Was Changes Erythema and Assessment of Spontaneous Pain on a Visual Analog Scale (0-10). | 0, 1, 2, 4, 6 weeks | The secondary efficacy variables were change in the size of the target erosion, erythema and assessment of spontaneous pain on a visual analog scale (0-10). The scale used to measure erythema is 0-3. 0 is no erythema, 1 is mild erythema, 2 is moderate erythema, and 3 is severe erythema. Minimum score is 0. Maximum score is 3. Spontaneous pain was scored on a scale of 0-10 (0 no pain, 10 severe pain). Measurments were completed day 0, week 1, week 2, week 4, and week 6. Scores are listed at baseline (day 0) and end of study (week 6). |
| Secondary | The Secondary Efficacy Variable Was Change in the Size of a Target Erosion in Millimeters. | 0, 1, 2, 4, 6 weeks | Secondary outcome variable was change in size of the target erosion in millimeters from baseline compared to week 6. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Primary Efficacy Variable Was the Change in the Investigator's Global Assessment of the Overall Severity of Disease From Baseline to Week 6. | 0, 1, 2, 4, 6 weeks | ITT using last observation carried forward for missing data | units on a scale | MEAN |
| SECONDARY | The Secondary Efficacy Variables Was Changes Erythema and Assessment of Spontaneous Pain on a Visual Analog Scale (0-10). | 0, 1, 2, 4, 6 weeks | units on a scale | MEAN | |
| SECONDARY | The Secondary Efficacy Variable Was Change in the Size of a Target Erosion in Millimeters. | 0, 1, 2, 4, 6 weeks | mm | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Primary Efficacy Variable Was the Change in the Investigator's Global Assessment of the Overall Severity of Disease From Baseline to Week 6. | Pimecrolimus Cream | baseline | 2.4 | Full Range 2 to 4 | units on a scale |
| The Primary Efficacy Variable Was the Change in the Investigator's Global Assessment of the Overall Severity of Disease From Baseline to Week 6. | Vehicle Cream | baseline | 2.45 | Full Range 1 to 3 | units on a scale |
| The Primary Efficacy Variable Was the Change in the Investigator's Global Assessment of the Overall Severity of Disease From Baseline to Week 6. | Pimecrolimus Cream | week 6 | 1.6 | Full Range 0 to 2 | units on a scale |
| The Primary Efficacy Variable Was the Change in the Investigator's Global Assessment of the Overall Severity of Disease From Baseline to Week 6. | Vehicle Cream | week 6 | 2.27 | Full Range 1 to 4 | units on a scale |
| The Secondary Efficacy Variables Was Changes Erythema and Assessment of Spontaneous Pain on a Visual Analog Scale (0-10). | Pimecrolimus Cream | mean erythema baseline | 2 | Full Range 0 to 3 | units on a scale |
| The Secondary Efficacy Variables Was Changes Erythema and Assessment of Spontaneous Pain on a Visual Analog Scale (0-10). | Vehicle Cream | mean erythema baseline | 2 | Full Range 0 to 3 | units on a scale |
| The Secondary Efficacy Variables Was Changes Erythema and Assessment of Spontaneous Pain on a Visual Analog Scale (0-10). | Pimecrolimus Cream | mean erythema week 6 | 1 | Full Range 0 to 2 | units on a scale |
| The Secondary Efficacy Variables Was Changes Erythema and Assessment of Spontaneous Pain on a Visual Analog Scale (0-10). | Vehicle Cream | mean erythema week 6 | 1 | Full Range 0 to 2 | units on a scale |
| The Secondary Efficacy Variables Was Changes Erythema and Assessment of Spontaneous Pain on a Visual Analog Scale (0-10). | Pimecrolimus Cream | mean pain baseline | 3 | Full Range 0 to 7 | units on a scale |
| The Secondary Efficacy Variables Was Changes Erythema and Assessment of Spontaneous Pain on a Visual Analog Scale (0-10). | Vehicle Cream | mean pain baseline | 4 | Full Range 0 to 8 | units on a scale |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pimecrolimus 1% Cream | 10 | |
| Overall Study | STARTED | Vehicle Cream | 11 | |
| Overall Study | COMPLETED | Pimecrolimus 1% Cream | 8 | |
| Overall Study | COMPLETED | Vehicle Cream | 11 | |
| Overall Study | NOT COMPLETED | Pimecrolimus 1% Cream | 2 | |
| Overall Study | NOT COMPLETED | Vehicle Cream | 0 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | upper respiratory infection | Infections and infestations | Pimecrolimus 1% Cream | 4 | 10 | 4 |
| other | upper respiratory infection | Infections and infestations | Vehicle Cream | 4 | 11 | 4 |
| other | blister on gum | Skin and subcutaneous tissue disorders | Pimecrolimus 1% Cream | 0 | 10 | 0 |
| other | blister on gum | Skin and subcutaneous tissue disorders | Vehicle Cream | 1 | 11 | 1 |
| other | leg fracture | Musculoskeletal and connective tissue disorders | Pimecrolimus 1% Cream | 1 | 10 | 1 |
| other | leg fracture | Musculoskeletal and connective tissue disorders | Vehicle Cream | 0 | 11 | 0 |
| other | cold sore on lip | Skin and subcutaneous tissue disorders | Pimecrolimus 1% Cream | 0 | 10 | 0 |
| other | cold sore on lip | Skin and subcutaneous tissue disorders | Vehicle Cream | 1 | 11 | 1 |
| other | flu-like illness | Gastrointestinal disorders | Pimecrolimus 1% Cream | 0 | 10 | 0 |
| other | flu-like illness | Gastrointestinal disorders | Vehicle Cream | 1 | 11 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pimecrolimus 1% Cream | ||
| Total, all-cause mortality | Vehicle Cream | ||
| Total, other adverse events | Pimecrolimus 1% Cream | 5 | 10 |
| Total, other adverse events | Vehicle Cream | 7 | 11 |
| Total, serious adverse events | Pimecrolimus 1% Cream | 0 | 10 |
| Total, serious adverse events | Vehicle Cream | 0 | 11 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21175873 | RESULT |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Pimecrolimus 1% Cream vs Vehicle Cream: serious adverse events |
Source Trial comparisons
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/NCT00297037
GET https://conductscience.org/api/trials/v1/NCT00297037/registered