Study of Apremilast in Atopic or Contact Dermatitis

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by:
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT00931242
First received: June 30, 2009
Last updated: November 23, 2010
Last verified: November 2010
Results First Received: October 28, 2010  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Atopic Dermatitis
Allergic Contact Dermatitis
Intervention: Drug: Apremilast

  Participant Flow
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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
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Reporting Groups
  Description
Apremilast Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
Screen Failures Patients who were screened but failed to meet inclusion criteria for the study

Participant Flow:   Overall Study
    Apremilast     Screen Failures  
STARTED     10     2  
COMPLETED     5     0  
NOT COMPLETED     5     2  



  Baseline Characteristics
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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
Apremilast Apremilast is being evaluated at daily doses of 20 mg PO (by mouth) twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type atopic dermatitis or allergic contact dermatitis.
Screen Failures Subjects that were screened but failed to meet inclusion criteria for the study.
Total Total of all reporting groups

Baseline Measures
    Apremilast     Screen Failures     Total  
Number of Participants  
[units: participants]
  10     2     12  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     8     2     10  
>=65 years     2     0     2  
Age  
[units: years]
Mean ± Standard Deviation
  43.3  ± 14.2442971     53.4  ± 4.5     45  ± 13.0384048  
Gender  
[units: participants]
     
Female     5     2     7  
Male     5     0     5  
Region of Enrollment  
[units: participants]
     
United States     10     2     12  



  Outcome Measures
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1.  Primary:   Number of Patients Achieving an Improvement (Decrease) in IGA (Investigator Global Assessment) by Two or More Points   [ Time Frame: 12 weeks ]

2.  Secondary:   Number of Patients Achieving 75% Reduction in Eczema Area and Severity Index (EASI) Score at Week 12 in Reference to Week 0   [ Time Frame: 12 weeks ]

3.  Secondary:   Number of Patients Achieving 50% Reduction in Eczema Area and Severity Index (EASI) Score at Week 12 in Reference to Week 0   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
This was a small, single-arm open-label study with no placebo or comparison group to serve as a control.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Alice B Gottlieb, MD, PhD
Organization: Tufts Medical Center
phone: 617 636 4802
e-mail: agottlieb@tuftsmedicalcenter.org


Publications:


Responsible Party: Alice B. Gottlieb, MD, PhD, Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00931242     History of Changes
Other Study ID Numbers: AD / CD, AP-ECZ-PI-0030
Study First Received: June 30, 2009
Results First Received: October 28, 2010
Last Updated: November 23, 2010
Health Authority: United States: Food and Drug Administration