Trial · NCT04908280
Study of Ruxolitinib Cream for the Treatment of Discoid Lupus Erythematosus
NCT04908280, Phase 2, Completed, University of Rochester; results first posted 2025-05-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Ruxolitinib Cream for the Treatment of Discoid Lupus Erythematosus. Trials, record NCT04908280. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04908280
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Ruxolitinib Cream for the Treatment of Discoid Lupus Erythematosus
- NCT number
- NCT04908280
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- University of Rochester
- Conditions
- Discoid Lupus Erythematosus
- Interventions
- Ruxolitinib
- First posted
- 2021-06-01
- Last updated
- 2025-05-20
- Results first posted
- 2025-05-20
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Severity of Disease as Measured by the Investigator's Global Assessment | 12 weeks | The Investigator's Global Assessment will be performed at study visits 2-6. The IGA is an instrument to rate the severity of the subject's global disease. This IGA is comprised of a 5-point scale of disease activity ranging from 0 to 4 as follows: 0: "clear," no erythema or scale 1. "almost clear," pink erythema without scale 2. "mild," pink erythema with scale 3. "moderate," red erythema with scale 4. "severe," purple/violaceous or hemorrhagic/crusted erythema OR hypertrophic/ verrucous scale Range of scores are 0-4 with higher scores indicating worse outcome. |
| Secondary | Mean Percentage Change in Disease Activity as Measured by the Cutaneous Lupus Area and Severity Index-A (CLASI) | Baseline to 12 weeks | The Cutaneous Lupus Area and Severity Index (CLASI) will be performed at study visits 2-6. This is a validated measurement instrument designed for use in clinical trials to assess disease activity and damage in subjects with cutaneous lupus. The CLASI is comprised of two parts, CLASI-A that measures disease activity (erythema and scale), and CLASI-D that measures disease damage (pigmentation and scarring). CLASI-A scores range from 0 to 70 with higher scores indicating worse outcomes. |
| Secondary | Mean Change in Itch Symptoms | Baseline to 12 weeks | Subjects will maintain a symptom diary every day for 12 weeks. Specifically, subjects will rate pain and itch separately using a numeric rating scale (NRS) and the questions below. Symptom diaries will be reviewed at study visits 2-6. "On a scale of "no itch" (0) to "worst imaginable itch" (10), how was your worst itch in the 24 hours?" Scores will range from 0-10 with higher scores indicating worse outcome. |
| Secondary | Mean Change in Pain Symptoms | Baseline to 12 weeks | Subjects will maintain a symptom diary every day for 12 weeks. Specifically, subjects will rate pain and itch separately using a numeric rating scale (NRS) and the questions below. Symptom diaries will be reviewed at study visits 2-6. "On a scale of "no skin pain" (0) to "worst imaginable skin pain" (10), how was your worst skin pain in the 24 hours?" Scores will range from 0-10 with higher scores indicating worse outcome. |
| Secondary | Mean Change in Melanin Index Score | Baseline to 12 weeks | Photographs of all discoid lesions will be taken at baseline and week 12. The Haiku app will be used to directly load photos into the secure Epic medical record system. Images will be extracted from Epic, and analyzed. In brief, a melanin index (MI) will be generated for each lesion using Image J software analysis. The measurement will be a ratio comparing the pigmentation of the lesion to non-lesion skin. The analysis uses perilesional skin to normalize the photograph. Measurements will range from 0 to 10. Scores further from a score of 1 will indicate more severe outcomes. |
| Secondary | Mean Change in Erythema Index Score | Baseline to 12 weeks | Photographs of all discoid lesions will be taken at baseline and week 12. The Haiku app will be used to directly load photos into the secure Epic medical record system. Images will be extracted from Epic, and analyzed. In brief, an erythema index (EI) will be generated for each lesion using Image J software analysis. The measurement will be a ratio comparing the erythema of the lesion to non-lesion skin. The analysis uses perilesional skin to normalize the photograph. Measurements will range from 0 to 10. Scores further from a score of 1 will indicate more severe outcomes. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Severity of Disease as Measured by the Investigator's Global Assessment | 12 weeks | score on a scale | MEAN | |
| SECONDARY | Mean Percentage Change in Disease Activity as Measured by the Cutaneous Lupus Area and Severity Index-A (CLASI) | Baseline to 12 weeks | percentage of change in disease activity | MEAN | |
| SECONDARY | Mean Change in Itch Symptoms | Baseline to 12 weeks | score on a scale | MEAN | |
| SECONDARY | Mean Change in Pain Symptoms | Baseline to 12 weeks | score on a scale | MEAN | |
| SECONDARY | Mean Change in Melanin Index Score | Baseline to 12 weeks | score on a scale | MEAN | |
| SECONDARY | Mean Change in Erythema Index Score | Baseline to 12 weeks | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Severity of Disease as Measured by the Investigator's Global Assessment | Discoid Lupus Erythematosus | 1.4 | Standard Error 0.84 | score on a scale | |
| Mean Percentage Change in Disease Activity as Measured by the Cutaneous Lupus Area and Severity Index-A (CLASI) | Discoid Lupus Erythematosus | -30.2 | Standard Deviation 25.8 | percentage of change in disease activity | |
| Mean Change in Itch Symptoms | Discoid Lupus Erythematosus | 0.67 | Standard Deviation 2.00 | score on a scale | |
| Mean Change in Pain Symptoms | Discoid Lupus Erythematosus | 0.67 | Standard Deviation 2.00 | score on a scale | |
| Mean Change in Melanin Index Score | Discoid Lupus Erythematosus | baseline | 2.28 | Standard Deviation 1.18 | score on a scale |
| Mean Change in Melanin Index Score | Discoid Lupus Erythematosus | 12 weeks | 2.73 | Standard Deviation 2.36 | score on a scale |
| Mean Change in Erythema Index Score | Discoid Lupus Erythematosus | baseline | 1.87 | Standard Deviation 0.74 | score on a scale |
| Mean Change in Erythema Index Score | Discoid Lupus Erythematosus | 12 weeks | 1.18 | Standard Deviation 0.18 | score on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Discoid Lupus Erythematosus | 10 | |
| Overall Study | COMPLETED | Discoid Lupus Erythematosus | 10 | |
| Overall Study | NOT COMPLETED | Discoid Lupus Erythematosus | 0 |
Source ClinicalTrials.gov
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 totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Discoid Lupus Erythematosus | 0 | 10 |
| Total, other adverse events | Discoid Lupus Erythematosus | 0 | 10 |
| Total, serious adverse events | Discoid Lupus Erythematosus | 0 | 10 |
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 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/NCT04908280
GET https://conductscience.org/api/trials/v1/NCT04908280/registered