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Trial record 44 of 711 for:    lupus AND Lupus Erythematosus, Systemic

Safety and Efficacy of Topical R333 in Patients With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Lesions (SKINDLE)

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ClinicalTrials.gov Identifier: NCT01597050
Recruitment Status : Completed
First Posted : May 11, 2012
Results First Posted : June 8, 2016
Last Update Posted : July 14, 2016
Sponsor:
Information provided by (Responsible Party):
Rigel Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Lupus Erythematosus, Discoid
Lupus Erythematosus, Systemic
Interventions Drug: R932333
Drug: Placebo
Enrollment 54

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Drug: R932333 Placebo
Hide Arm/Group Description

R333 6% (60 mg/g), bid

R932333: R393233 6% (60 mg/g), bid

Placebo, bid

Placebo: Placebo, bid

Period Title: Overall Study
Started 36 18
Completed 35 18
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Drug: R932333 Placebo Total
Hide Arm/Group Description

R333 6% (60 mg/g), bid

R932333: R393233 6% (60 mg/g), bid

Placebo, bid

Placebo: Placebo, bid

Total of all reporting groups
Overall Number of Baseline Participants 36 18 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 18 participants 54 participants
46.1  (11.3) 48.3  (12.57) 46.8  (11.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 18 participants 54 participants
Female
28
  77.8%
16
  88.9%
44
  81.5%
Male
8
  22.2%
2
  11.1%
10
  18.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 36 participants 18 participants 54 participants
Canada 7 2 9
United States 29 16 45
1.Primary Outcome
Title Decrease in the Total Combined Erythema and Scaling Score (Minimum of 0 and Maximum of 65) of All Treated Lesions.
Hide Description 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.
Time Frame Up to Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population all patients who had no major protocol deviations and were present at all scheduled visits up to and including Week 4.
Arm/Group Title Drug: R932333 Placebo
Hide Arm/Group Description:

R333 6% (60 mg/g), bid

R932333: R393233 6% (60 mg/g), bid

Placebo, bid

Placebo: Placebo, bid

Overall Number of Participants Analyzed 36 18
Measure Type: Number
Unit of Measure: percentage of subjects
22.2 27.8
Time Frame The AE reporting period begins with the first dose of double blind study drug and ends with the final study (follow-up) visit at week 6.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Drug: R932333 Placebo
Hide Arm/Group Description

R333 6% (60 mg/g), bid

R932333: R393233 6% (60 mg/g), bid

Placebo, bid

Placebo: Placebo, bid

All-Cause Mortality
Drug: R932333 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Drug: R932333 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/36 (0.00%)      0/18 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Drug: R932333 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/36 (44.44%)      10/18 (55.56%)    
Blood and lymphatic system disorders     
Leukopenia *  0/36 (0.00%)  0 1/18 (5.56%)  1
Lymphadenopathy *  0/36 (0.00%)  0 1/18 (5.56%)  1
Mean cell volume increased *  1/36 (2.78%)  1 0/18 (0.00%)  0
Neutrophil count increased *  1/36 (2.78%)  1 0/18 (0.00%)  0
White blood cell count increased *  1/36 (2.78%)  1 0/18 (0.00%)  0
Eye disorders     
Eyelid margin crusting *  1/36 (2.78%)  1 0/18 (0.00%)  0
Lacrimation increased *  1/36 (2.78%)  1 0/18 (0.00%)  0
Gastrointestinal disorders     
Vomiting *  4/36 (11.11%)  4 0/18 (0.00%)  0
Nausea *  2/36 (5.56%)  2 0/18 (0.00%)  0
Abdominal distension *  1/36 (2.78%)  1 0/18 (0.00%)  0
Diarrhoea *  1/36 (2.78%)  1 0/18 (0.00%)  0
Gastrooesophageal reflux disease *  1/36 (2.78%)  1 0/18 (0.00%)  0
Stomatitis *  1/36 (2.78%)  1 0/18 (0.00%)  0
General disorders     
Application site pain *  1/36 (2.78%)  1 1/18 (5.56%)  1
Application site pruritus *  2/36 (5.56%)  2 0/18 (0.00%)  0
Chest pain *  1/36 (2.78%)  1 0/18 (0.00%)  0
Fatigue *  0/36 (0.00%)  0 1/18 (5.56%)  1
Pain *  1/36 (2.78%)  1 0/18 (0.00%)  0
Pyrexia *  0/36 (0.00%)  0 1/18 (5.56%)  1
Infections and infestations     
Upper Respiratory Track Infection *  3/36 (8.33%)  3 3/18 (16.67%)  3
Sinusitis *  0/36 (0.00%)  0 2/18 (11.11%)  2
Laryngitis *  0/36 (0.00%)  0 1/18 (5.56%)  1
Investigations     
Blood bilirubin increased *  1/36 (2.78%)  1 0/18 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Musculoskeletal pain *  0/36 (0.00%)  0 1/18 (5.56%)  1
Pain in extremity *  1/36 (2.78%)  1 0/18 (0.00%)  0
Nervous system disorders     
Headache *  3/36 (8.33%)  3 1/18 (5.56%)  1
Migraine *  0/36 (0.00%)  0 1/18 (5.56%)  1
Psychiatric disorders     
Insomnia *  1/36 (2.78%)  1 0/18 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Sinus congestion *  3/36 (8.33%)  3 0/18 (0.00%)  0
Oropharyngeal pain *  2/36 (5.56%)  2 0/18 (0.00%)  0
Respiratory tract congestion *  1/36 (2.78%)  1 0/18 (0.00%)  0
Skin and subcutaneous tissue disorders     
Pruritus *  1/36 (2.78%)  1 2/18 (11.11%)  2
Skin lesion *  0/36 (0.00%)  0 2/18 (11.11%)  2
Erythema *  1/36 (2.78%)  1 0/18 (0.00%)  0
Rash *  0/36 (0.00%)  0 1/18 (5.56%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Anne-Marie Duliege, MD
Organization: Rigel
Phone: 650-624-1100
Responsible Party: Rigel Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01597050     History of Changes
Other Study ID Numbers: C-932333-002
First Submitted: May 9, 2012
First Posted: May 11, 2012
Results First Submitted: April 28, 2016
Results First Posted: June 8, 2016
Last Update Posted: July 14, 2016