Trial · NCT01597050
Safety and Efficacy of Topical R333 in Patients With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Lesions
NCT01597050, Phase 2, Completed, Rigel Pharmaceuticals; results first posted 2016-06-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Topical R333 in Patients With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Lesions. Trials, record NCT01597050. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01597050
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Topical R333 in Patients With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Lesions
- NCT number
- NCT01597050
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 54 participants, actual
- Lead sponsor
- Rigel Pharmaceuticals
- Conditions
- Lupus Erythematosus, Discoid, Lupus Erythematosus, Systemic
- Interventions
- R932333, Placebo
- First posted
- 2012-05-11
- Last updated
- 2016-07-14
- Results first posted
- 2016-06-08
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Decrease in the Total Combined Erythema and Scaling Score (Minimum of 0 and Maximum of 65) of All Treated Lesions. | Up to Week 4 | Percentage of patients who achieved at least a 50% decrease from baseline in the total combined Erythema and Scaling score of all treated lesions at Week 4. A decrease is an improvement in measurement of erythema and scaling of the lesions. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Decrease in the Total Combined Erythema and Scaling Score (Minimum of 0 and Maximum of 65) of All Treated Lesions. | Up to Week 4 | Per-protocol population all patients who had no major protocol deviations and were present at all scheduled visits up to and including Week 4. | percentage of subjects | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Decrease in the Total Combined Erythema and Scaling Score (Minimum of 0 and Maximum of 65) of All Treated Lesions. | Drug: R932333 | 22.2 | percentage of subjects | ||
| Decrease in the Total Combined Erythema and Scaling Score (Minimum of 0 and Maximum of 65) of All Treated Lesions. | Placebo | 27.8 | percentage of subjects |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Drug: R932333 | 36 | |
| Overall Study | STARTED | Placebo | 18 | |
| Overall Study | COMPLETED | Drug: R932333 | 35 | |
| Overall Study | COMPLETED | Placebo | 18 | |
| Overall Study | NOT COMPLETED | Drug: R932333 | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events70
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 Track Infection | Infections and infestations | Drug: R932333 | 3 | 36 | 3 |
| other | Upper Respiratory Track Infection | Infections and infestations | Placebo | 3 | 18 | 3 |
| other | Vomiting | Gastrointestinal disorders | Drug: R932333 | 4 | 36 | 4 |
| other | Vomiting | Gastrointestinal disorders | Placebo | 0 | 18 | 0 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Drug: R932333 | 1 | 36 | 1 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Placebo | 2 | 18 | 2 |
| other | Application site pain | General disorders | Drug: R932333 | 1 | 36 | 1 |
| other | Application site pain | General disorders | Placebo | 1 | 18 | 1 |
| other | Headache | Nervous system disorders | Drug: R932333 | 3 | 36 | 3 |
| other | Headache | Nervous system disorders | Placebo | 1 | 18 | 1 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Drug: R932333 | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Drug: R932333 | 16 | 36 |
| Total, other adverse events | Placebo | 10 | 18 |
| Total, serious adverse events | Drug: R932333 | 0 | 36 |
| Total, serious adverse events | Placebo | 0 | 18 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33687069 | DERIVED |
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 |
|---|
| Drug: R932333 vs Placebo: 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/NCT01597050
GET https://conductscience.org/api/trials/v1/NCT01597050/events?page=2