Safety and Efficacy of Topical R333 in Patients With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Lesions
SKINDLE
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of R333 6% Ointment Administered Topically to Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Patients With Active Cutaneous Discoid Lesions
1 other identifier
interventional
54
2 countries
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2012
Shorter than P25 for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2012
CompletedFirst Posted
Study publicly available on registry
May 11, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedResults Posted
Study results publicly available
June 8, 2016
CompletedJuly 14, 2016
June 1, 2016
1.1 years
May 9, 2012
April 28, 2016
June 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Decrease in the Total Combined Erythema and Scaling Score (Minimum of 0 and Maximum of 65) of All Treated Lesions.
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.
Up to Week 4
Study Arms (2)
Drug: R932333
ACTIVE COMPARATORR333 6% (60 mg/g), bid
Placebo
PLACEBO COMPARATORPlacebo, bid
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Wallace Rheumatic Study Center
Los Angeles, California, 90027, United States
Stanford Dermatology
Redwood City, California, 94063, United States
Memorial Medical Group Clinical Research Institute
South Bend, Indiana, 46601, United States
North Shore Long Island Health System
Lake Success, New York, 11042, United States
Columbia University Medical Center
New York, New York, 10032, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27104, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104, United States
University of Pennsylvania-Dermatology Research Office
Philadelphia, Pennsylvania, 19104, United States
Metroplex Clinical Research Center
Dallas, Texas, 75231, United States
University of Texas Medical School at Houston
Houston, Texas, 77030, United States
University of Utah Department of Dermatology
Salt Lake City, Utah, 84132, United States
Virginia Clinical Research, Inc
Norfolk, Virginia, 23507, United States
University of British Columbia, Vancouver Dermatology Clinical Trials Unit
Vancouver, British Columbia, V5Z 4E8, Canada
Dermadvances Research
Winnipeg, Manitoba, R3C 1R4, Canada
Lynderm Research, Inc
Markham, Ontario, L3P 1A8, Canada
Related Publications (1)
Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
PMID: 33687069DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Anne-Marie Duliege, MD
- Organization
- Rigel
Study Officials
- STUDY DIRECTOR
Daniel Magilavy, MD
Rigel Pharmaceuticals,Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2012
First Posted
May 11, 2012
Study Start
August 1, 2012
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
July 14, 2016
Results First Posted
June 8, 2016
Record last verified: 2016-06