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Alefacept in Patients With Severe Scalp Alopecia Areata

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00167102
First Posted: September 14, 2005
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Alopecia Areata Foundation
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
Results First Submitted: February 27, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Other
Condition: Alopecia Areata
Intervention: Drug: Alefacept

  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
No text entered.

Reporting Groups
  Description
Alefacept Weekly IM administration of alefacept,15 mg, for 12 weeks, followed by a 12-week, posttreatment observation period.
Placebo Weekly IM administration of placebo, for 12 weeks, followed by a 12-week, posttreatment observation period.

Participant Flow:   Overall Study
    Alefacept   Placebo
STARTED   23   22 
COMPLETED   23   22 
NOT COMPLETED   0   0 



  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.
23 participants were allocated to alefacept 22 participants were allocated to placebo

Reporting Groups
  Description
Alefacept No text entered.
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
   Alefacept   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 23   22   45 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      23 100.0%      22 100.0%      45 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.3  (10.3)   34.2  (11.8)   36.3  (11.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      18  78.3%      14  63.6%      32  71.1% 
Male      5  21.7%      8  36.4%      13  28.9% 
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: 24 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 reported.   Anticipated Reporting Date:   No text entered.  

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 reported.   Anticipated Reporting Date:   No text entered.  


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


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



Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00167102     History of Changes
Other Study ID Numbers: 0506M70377
First Submitted: September 9, 2005
First Posted: September 14, 2005
Results First Submitted: February 27, 2013
Results First Posted: April 9, 2013
Last Update Posted: July 13, 2017