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Use of Etanercept in the Treatment of Moderate to Severe Lichen Planus

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ClinicalTrials.gov Identifier: NCT00285779
Recruitment Status : Terminated (Slow recruitment)
First Posted : February 2, 2006
Results First Posted : March 3, 2015
Last Update Posted : March 21, 2018
Sponsor:
Collaborators:
Wright State University
Tufts Medical Center
University of Louisville
Wake Forest University Health Sciences
University of Michigan
Emory University
University Hospitals Cleveland Medical Center
Icahn School of Medicine at Mount Sinai
Oregon Health and Science University
The Cleveland Clinic
Fivenson, David, M.D.
Information provided by (Responsible Party):
David Fiorentino, Stanford University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Lichen Planus
Interventions: Drug: Etanercept
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This is a randomized, multi-center interventional trial in which patients were recruited at 11 sites in the United States (10 academic and one private practice). Enrollment was between June, 2006 and December, 2008. The first subject was enrolled in August, 2006 and the last patient was enrolled in November, 2008.

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
Placebo Injection Placebo: Normal saline twice weekly for 12 weeks
Etanercept Etanercept: etanercept 50 mg twice weekly for 12 weeks

Participant Flow for 3 periods

Period 1:   Placebo-controlled Period (wk 1-12)
    Placebo Injection   Etanercept
STARTED   14   13 
COMPLETED   11   12 
NOT COMPLETED   3   1 

Period 2:   Open Label Period (wk 12-24)
    Placebo Injection   Etanercept
STARTED   11   12 
COMPLETED   9   10 
NOT COMPLETED   2   2 

Period 3:   Follow-up Period (wk 24-32)
    Placebo Injection   Etanercept
STARTED   9   10 
COMPLETED   8   10 
NOT COMPLETED   1   0 



  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
Placebo Injection Placebo: Normal saline twice weekly for 12 weeks
Etanercept Etanercept: etanercept 50 mg twice weekly for 12 weeks
Total Total of all reporting groups

Baseline Measures
   Placebo Injection   Etanercept   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   13   27 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.4  (16.9)   57.4  (16.0)   53.7  (16.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      8  57.1%      8  61.5%      16  59.3% 
Male      6  42.9%      5  38.5%      11  40.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      3  21.4%      3  23.1%      6  22.2% 
White      11  78.6%      10  76.9%      21  77.8% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   The Percentage of Patients Achieving a Response in Mucosal Disease (or Cutaneous Disease if no Mucosal Disease) at 12 Weeks   [ Time Frame: 12 weeks ]

2.  Secondary:   Count of Patients Achieving a Response in Cutaneous or Mucosal Disease at 24 Weeks   [ Time Frame: Baseline; Week 24 ]

3.  Secondary:   The Physician Assessment of Surface Area of Disease (PSAD) for Oral Disease at 12 and 24 Weeks   [ Time Frame: Baseline; Week 12; Week 24 ]

4.  Secondary:   The Physician Assessment of Surface Area of Disease (PSAD) for Genital Disease at 12 and 24 Weeks   [ Time Frame: Baseline; Week 12; Week 24 ]

5.  Secondary:   The Physician Assessment of Surface Area of Disease (PSAD) for Skin Disease at 12 and 24 Weeks   [ Time Frame: Baseline; Week 12; Week 24 ]

6.  Secondary:   Cutaneous Target Lesion Scores - Erythema, at 12 and 24 Weeks   [ Time Frame: Week 12; Week 24 ]

7.  Secondary:   Cutaneous Target Lesion Scores - Elevation, at 12 and 24 Weeks   [ Time Frame: Week 12; Week 24 ]

8.  Secondary:   Cutaneous Target Lesion Scores - Scale, at 12 and 24 Weeks   [ Time Frame: Week 12; Week 24 ]

9.  Secondary:   Cutaneous Target Lesion Scores - Total, at 12 and 24 Weeks   [ Time Frame: Week 12; Week 24 ]

10.  Secondary:   Patient Assessment of Pain on a Visual Analogue Scale (VAS) at 12 and 24 Weeks   [ Time Frame: Baseline; Week 12; Week 24 ]

11.  Secondary:   Patient Assessment of Pruritus (Itching) on a Visual Analogue Scale (VAS) at 12 and 24 Weeks   [ Time Frame: Baseline; Week 12; Week 24 ]

12.  Secondary:   Patient Assessment of Overall Disease Severity (Patient Global Assessment) at 12 and 24 Weeks   [ Time Frame: Baseline; Week 12; Week 24 ]

13.  Secondary:   The Count of Subjects Experiencing Serious Adverse Events (SAEs) by Week 12 and Week 24   [ Time Frame: Baseline; Week 12; Week 24 ]

14.  Secondary:   The Count of Placebo Patients Who do Not Have a Complete Response (Defined as a Physician Global Assessment of "Clear") at 12 Weeks   [ Time Frame: 12 weeks ]

15.  Secondary:   The Percentage of Placebo and Study-drug Patients Able to Discontinue Use of Topical Corticosteroids Through Week 24   [ Time Frame: 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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
Trial was terminated early due to low recruitment rates.


  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: David Fiorentino
Organization: Stanford University Department of Dermatology
phone: 650-723-6316
e-mail: fiorentino@stanford.edu



Responsible Party: David Fiorentino, Stanford University
ClinicalTrials.gov Identifier: NCT00285779     History of Changes
Obsolete Identifiers: NCT00568581, NCT00691106
Other Study ID Numbers: 20041132
First Submitted: January 31, 2006
First Posted: February 2, 2006
Results First Submitted: January 28, 2015
Results First Posted: March 3, 2015
Last Update Posted: March 21, 2018