Alefacept in Patients With Severe Scalp Alopecia Areata

This study has been completed.
Sponsor:
Collaborator:
National Alopecia Areata Foundation
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00167102
First received: September 9, 2005
Last updated: February 27, 2013
Last verified: February 2013
Results First Received: February 27, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator)
Condition: Alopecia Areata
Intervention: Drug: Alefacept

  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
Alefacept No text entered.
Placebo No text entered.

Participant Flow:   Overall Study
    Alefacept     Placebo  
STARTED     23     22  
COMPLETED     23     22  
NOT COMPLETED     0     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
Alefacept No text entered.
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
    Alefacept     Placebo     Total  
Number of Participants  
[units: participants]
  23     22     45  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     23     22     45  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  38.3  ± 10.3     34.2  ± 11.8     36.3  ± 11.1  
Gender  
[units: participants]
     
Female     18     14     32  
Male     5     8     13  
Region of Enrollment  
[units: participants]
     
United States     23     22     45  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Proportion of Subjects Achieving at Least a 50% Reduction in Their Scalp Alopecia Areata Severity Scores (SALT Score) From Baseline Values   [ Time Frame: 12 weeks ]

2.  Primary:   Number of Adverse Events   [ Time Frame: 24 weeks ]

3.  Secondary:   In Those Who Respond to Treatment, the Durability of the Response Will be Assessed Over a 12-week Post-treatment Period of Observation.   [ Time Frame: 12 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   To Qualitatively Assess the Subjects Perception of Their Scalp Disease With Treatment, and Upon Withdrawal of Treatment, in Relation to Baseline.   [ Time Frame: 12 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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
This study was limited by the number of patients randomized to receive treatment.


  More Information
  Hide More Information

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: Dr. Maria Hordinsky
Organization: University of Minnesota
phone: 612-624-5721
e-mail: hordi001@umn.edu


No publications provided


Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00167102     History of Changes
Other Study ID Numbers: 0506M70377
Study First Received: September 9, 2005
Results First Received: February 27, 2013
Last Updated: February 27, 2013
Health Authority: United States: Institutional Review Board