Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rigel Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01597050
First received: May 9, 2012
Last updated: June 15, 2016
Last verified: June 2016
Results First Received: April 28, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Lupus Erythematosus, Discoid
Lupus Erythematosus, Systemic
Interventions: Drug: R932333
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Drug: R932333

R333 6% (60 mg/g), bid

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

Placebo

Placebo, bid

Placebo: Placebo, bid


Participant Flow:   Overall Study
    Drug: R932333     Placebo  
STARTED     36     18  
COMPLETED     35     18  
NOT COMPLETED     1     0  
Withdrawal by Subject                 1                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Drug: R932333

R333 6% (60 mg/g), bid

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

Placebo

Placebo, bid

Placebo: Placebo, bid

Total Total of all reporting groups

Baseline Measures
    Drug: R932333     Placebo     Total  
Number of Participants  
[units: participants]
  36     18     54  
Age  
[units: years]
Mean (Standard Deviation)
  46.1  (11.3)     48.3  (12.57)     46.8  (11.69)  
Gender  
[units: participants]
     
Female     28     16     44  
Male     8     2     10  
Region of Enrollment  
[units: participants]
     
Canada     7     2     9  
United States     29     16     45  



  Outcome Measures

1.  Primary:   Decrease in the Total Combined Erythema and Scaling Score (Minimum of 0 and Maximum of 65) of All Treated Lesions.   [ Time Frame: Up to Week 4 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: clinicaltrials@rigel.com



Responsible Party: Rigel Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01597050     History of Changes
Other Study ID Numbers: C-932333-002
Study First Received: May 9, 2012
Results First Received: April 28, 2016
Last Updated: June 15, 2016
Health Authority: United States: Food and Drug Administration
Canada: Health Canada