Trial · NCT00285779
Use of Etanercept in the Treatment of Moderate to Severe Lichen Planus
NCT00285779, Phase 2, Terminated, Stanford University; results first posted 2015-03-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Use of Etanercept in the Treatment of Moderate to Severe Lichen Planus. Trials, record NCT00285779. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00285779
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Use of Etanercept in the Treatment of Moderate to Severe Lichen Planus
- NCT number
- NCT00285779
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Lichen Planus
- Interventions
- Etanercept, Placebo
- First posted
- 2006-02-02
- Last updated
- 2018-03-21
- Results first posted
- 2015-03-03
- Limitations and caveats
- Trial was terminated early due to low recruitment rates.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percentage of Patients Achieving a Response in Mucosal Disease (or Cutaneous Disease if no Mucosal Disease) at 12 Weeks | 12 weeks | Physician global assessment of disease scores: 0=clear; 1=minimal disease; 2=mild disease; 3=moderate disease; 4=severe disease. Subjects had a level \>=3 at baseline. To be considered a responder, the subject must achieve a level of 0 or 1, or, at least a 2 point improvement in the scale. |
| Secondary | Count of Patients Achieving a Response in Cutaneous or Mucosal Disease at 24 Weeks | Baseline; Week 24 | Physician global assessment of disease scores: 0=clear; 1=minimal disease; 2=mild disease; 3=moderate disease; 4=severe disease. Subjects had a level \>=3 at baseline. To be considered a responder, the subject must achieve a level of 0 or 1, or, at least a 2 point improvement in the scale. |
| Secondary | The Physician Assessment of Surface Area of Disease (PSAD) for Oral Disease at 12 and 24 Weeks | Baseline; Week 12; Week 24 | The percentage of surface area involved with disease is reported as assessed by the physician using a Likert scale. Assessment scores range from 0-5, with lower scores corresponding lower percentage of surface area with disease. 0=clear, 1=\<2%, 2=2-9%, 3=10-29%, 4=30-50%, 5=\>50%. |
| Secondary | The Physician Assessment of Surface Area of Disease (PSAD) for Genital Disease at 12 and 24 Weeks | Baseline; Week 12; Week 24 | The percentage of surface area involved with disease is reported as assessed by the physician using a Likert scale. Assessment scores range from 0-5, with lower scores corresponding lower percentage of surface area with disease. 0=clear, 1=\<2%, 2=2-9%, 3=10-29%, 4=30-50%, 5=\>50%. |
| Secondary | The Physician Assessment of Surface Area of Disease (PSAD) for Skin Disease at 12 and 24 Weeks | Baseline; Week 12; Week 24 | The percentage of surface area involved with disease is reported as assessed by the physician using a Likert scale. Assessment scores range from 0-5, with lower scores corresponding lower percentage of surface area with disease. 0=clear, 1=\<2%, 2=2-9%, 3=10-29%, 4=30-50%, 5=\>50%. |
| Secondary | Cutaneous Target Lesion Scores - Erythema, at 12 and 24 Weeks | Week 12; Week 24 | This is an investigator-based assessment of a single preselected target skin lesion. Assessment scores range from 0-3 on a Likert scale, with higher scores meaning worse erythema. 0=clear, 1=mild/pink, 2=moderately red, 3=severely red/violaceous. |
| Secondary | Cutaneous Target Lesion Scores - Elevation, at 12 and 24 Weeks | Week 12; Week 24 | This is an investigator-based assessment of a single preselected target skin lesion. Assessment scores range from 0-3 on a Likert scale, with higher scores meaning worse elevation. 0=flat, 1=barely palpable (\<0.5 mm), 2=moderate (0.5 mm-1 mm), 3=severe (\>1 mm). |
| Secondary | Cutaneous Target Lesion Scores - Scale, at 12 and 24 Weeks | Week 12; Week 24 | This is an investigator-based assessment of a single preselected target skin lesion. Assessment scores range from 0-3 on a Likert scale, with higher scores meaning worse scaling. 0=none, 1=fine/dusty scale, 2=moderate scale, 3=thick/tenacious scale. |
| Secondary | Cutaneous Target Lesion Scores - Total, at 12 and 24 Weeks | Week 12; Week 24 | This score sums all of the 3 elements of the target lesion score (erythema, elevation, scale) described in Outcome Measures 6-8. Assessment scores range from 0-9 on a Likert scale, with higher numbers meaning more severe disease in the target skin lesion. |
| Secondary | Patient Assessment of Pain on a Visual Analogue Scale (VAS) at 12 and 24 Weeks | Baseline; Week 12; Week 24 | Participants were asked to indicate their pain level by marking it on a 10 cm linear VAS scale. The number of centimeters from the left end of the line to the mark was measured in cm. Total range was 0-10. Lower scores correspond to less pain, higher scores correspond to more pain. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Percentage of Patients Achieving a Response in Mucosal Disease (or Cutaneous Disease if no Mucosal Disease) at 12 Weeks | 12 weeks | Intention to treat analysis (all participants received at least one dose of study drug). Missing data imputed using Last Observation Carried Forward (LOCF). | percentage of participants | NUMBER |
| SECONDARY | Count of Patients Achieving a Response in Cutaneous or Mucosal Disease at 24 Weeks | Baseline; Week 24 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | The Physician Assessment of Surface Area of Disease (PSAD) for Oral Disease at 12 and 24 Weeks | Baseline; Week 12; Week 24 | Participants with missing data were excluded from the analysis. | units on a scale | MEAN |
| SECONDARY | The Physician Assessment of Surface Area of Disease (PSAD) for Genital Disease at 12 and 24 Weeks | Baseline; Week 12; Week 24 | Participants with missing data were excluded from the analysis. | units on a scale | MEAN |
| SECONDARY | The Physician Assessment of Surface Area of Disease (PSAD) for Skin Disease at 12 and 24 Weeks | Baseline; Week 12; Week 24 | Participants with missing data were excluded from the analysis. | units on a scale | MEAN |
| SECONDARY | Cutaneous Target Lesion Scores - Erythema, at 12 and 24 Weeks | Week 12; Week 24 | Participants with missing data were excluded from the analysis | units on a scale | MEAN |
| SECONDARY | Cutaneous Target Lesion Scores - Elevation, at 12 and 24 Weeks | Week 12; Week 24 | Participants with missing data were excluded from the analysis | units on a scale | MEAN |
| SECONDARY | Cutaneous Target Lesion Scores - Scale, at 12 and 24 Weeks | Week 12; Week 24 | Participants with missing data were excluded from the analysis | units on a scale | MEAN |
| SECONDARY | Cutaneous Target Lesion Scores - Total, at 12 and 24 Weeks | Week 12; Week 24 | Participants with missing data were excluded from the analysis | units on a scale | MEAN |
| SECONDARY | Patient Assessment of Pain on a Visual Analogue Scale (VAS) at 12 and 24 Weeks | Baseline; Week 12; Week 24 | Participants with missing data were excluded from the analysis. | units on a scale | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group69
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Percentage of Patients Achieving a Response in Mucosal Disease (or Cutaneous Disease if no Mucosal Disease) at 12 Weeks | Placebo Injection | 28.6 | percentage of participants | ||
| The Percentage of Patients Achieving a Response in Mucosal Disease (or Cutaneous Disease if no Mucosal Disease) at 12 Weeks | Etanercept | 0 | percentage of participants | ||
| Count of Patients Achieving a Response in Cutaneous or Mucosal Disease at 24 Weeks | Placebo Injection | 5 | Participants | ||
| Count of Patients Achieving a Response in Cutaneous or Mucosal Disease at 24 Weeks | Etanercept | 4 | Participants | ||
| The Physician Assessment of Surface Area of Disease (PSAD) for Oral Disease at 12 and 24 Weeks | Placebo Injection | Baseline | 1.2 | Standard Deviation 1.31 | units on a scale |
| The Physician Assessment of Surface Area of Disease (PSAD) for Oral Disease at 12 and 24 Weeks | Etanercept | Baseline | 1.6 | Standard Deviation 1.73 | units on a scale |
| The Physician Assessment of Surface Area of Disease (PSAD) for Oral Disease at 12 and 24 Weeks | Placebo Injection | Week 12 | 0.8 | Standard Deviation 1.03 | units on a scale |
| The Physician Assessment of Surface Area of Disease (PSAD) for Oral Disease at 12 and 24 Weeks | Etanercept | Week 12 | 1.5 | Standard Deviation 1.44 | units on a scale |
| The Physician Assessment of Surface Area of Disease (PSAD) for Oral Disease at 12 and 24 Weeks | Placebo Injection | Week 24 | 1.1 | Standard Deviation 1.10 | units on a scale |
| The Physician Assessment of Surface Area of Disease (PSAD) for Oral Disease at 12 and 24 Weeks | Etanercept | Week 24 | 1.5 | Standard Deviation 1.20 | units on a scale |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Placebo-controlled Period (wk 1-12) | STARTED | Placebo Injection | 14 | |
| Placebo-controlled Period (wk 1-12) | STARTED | Etanercept | 13 | |
| Placebo-controlled Period (wk 1-12) | COMPLETED | Placebo Injection | 11 | |
| Placebo-controlled Period (wk 1-12) | COMPLETED | Etanercept | 12 | |
| Placebo-controlled Period (wk 1-12) | NOT COMPLETED | Placebo Injection | 3 | |
| Placebo-controlled Period (wk 1-12) | NOT COMPLETED | Etanercept | 1 | |
| Open Label Period (wk 12-24) | STARTED | Placebo Injection | 11 | |
| Open Label Period (wk 12-24) | STARTED | Etanercept | 12 | |
| Open Label Period (wk 12-24) | COMPLETED | Placebo Injection | 9 | |
| Open Label Period (wk 12-24) | COMPLETED | Etanercept | 10 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events80
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 | Erythema at injection site | Skin and subcutaneous tissue disorders | Placebo Injection | 1 | 14 | 1 |
| other | Erythema at injection site | Skin and subcutaneous tissue disorders | Etanercept | 1 | 24 | 1 |
| other | Bruising at injection site | Skin and subcutaneous tissue disorders | Placebo Injection | 1 | 14 | 1 |
| other | Bruising at injection site | Skin and subcutaneous tissue disorders | Etanercept | 3 | 24 | 3 |
| other | Vaginal yeast infection | Infections and infestations | Placebo Injection | 1 | 14 | 1 |
| other | Vaginal yeast infection | Infections and infestations | Etanercept | 2 | 24 | 2 |
| other | Bladder spasms | Renal and urinary disorders | Placebo Injection | 0 | 14 | 0 |
| other | Bladder spasms | Renal and urinary disorders | Etanercept | 1 | 24 | 1 |
| other | Urinary tract infection | Infections and infestations | Placebo Injection | 0 | 14 | 0 |
| other | Urinary tract infection | Infections and infestations | Etanercept | 1 | 24 | 1 |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Injection | ||
| Total, all-cause mortality | Etanercept | ||
| Total, other adverse events | Placebo Injection | 4 | 14 |
| Total, other adverse events | Etanercept | 14 | 24 |
| Total, serious adverse events | Placebo Injection | 0 | 14 |
| Total, serious adverse events | Etanercept | 1 | 24 |
Source ClinicalTrials.gov
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Etanercept vs Placebo Injection: Count of Patients Achieving a Response in Cutaneous or Mucosal Disease at 24 Weeks | Trial comparisons |
| Etanercept vs Placebo Injection: serious adverse events | 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/NCT00285779
GET https://conductscience.org/api/trials/v1/NCT00285779/results?page=2