Phase 2
Completed N=54
Safety and Efficacy of Topical R333 in Patients With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Lesions
Lupus Erythematosus, Discoid · Lupus Erythematosus, Systemic
Source: ClinicalTrials.gov NCT01597050 ↗
Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcomePrimary: Decrease in the Total Combined Erythema and Scaling Score (Minimum of 0 and Maximum of 65) of All Treated Lesions. — 22.2; 27.8 percentage of subjects
Summary
The purpose of this study is to determine the safety, efficacy and tolerability of topical R333 ointment in Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) patients with active discoid lesions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Decrease in the Total Combined Erythema and Scaling Score (Minimum of 0 and Maximum of 65) of All Treated Lesions. |
22.2; 27.8 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of SLE or DLE (DLE confirmed histologically prior to randomization).
- At least 2 active discoid lesions secondary to SLE or DLE prior to study entry, each with a minimum Erythema Rating Score of ≥ 2. At least 1 of the active discoid lesions must have been present (by history) for ≥ 3 weeks prior to screening.
- Patients who are taking azathioprine, hydroxychloroquine, chloroquine, quinacrine, methotrexate, and/ or oral glucocorticoids, must be receiving a stable daily dose ≥ 4 weeks prior to randomization and must remain on the same dose throughout the study. Azathioprine, hydroxychloroquine, chloroquine, quinacrine, or methotrexate must be initiated ≥ 8 weeks prior to randomization.
Exclusion Criteria
- Congenital or acquired immunodeficiency including: HIV infection, agammaglobulinemias, T cell deficiencies or HTLV-1 infection at any time prior to the study.
- Lymphoproliferative disease or previous total lymphoid irradiation.
- Uncontrolled or poorly controlled hypertension.
- History of psoriasis, eczema, or relevant atopy.
- Exposure to excessive or chronic UV radiation (e.g., tanning beds, sunbathing, solarium, phototherapy) within 2 weeks prior to randomization or during the study period.
Data sourced from ClinicalTrials.gov (NCT01597050). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.