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Pilot Study to Evaluate the Efficacy of Ruxolitinib in Alopecia Areata

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.
 
ClinicalTrials.gov Identifier: NCT01950780
Recruitment Status : Completed
First Posted : September 25, 2013
Results First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Sponsor:
Collaborators:
Alopecia Areata Initiative - Gates Foundation
Locks of Love
Information provided by (Responsible Party):
Columbia University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Alopecia Areata
Intervention Drug: Ruxolitinib
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ruxolitinib
Hide Arm/Group Description

A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects.

Ruxolitinib: A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects.

Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title Ruxolitinib
Hide Arm/Group Description

A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects.

Ruxolitinib: A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects.

Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years 0
Between 18 and 65 years 12
>=65 years 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female 7
Male 5
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Hispanic or Latino
3
  25.0%
Not Hispanic or Latino
9
  75.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   8.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  25.0%
White
8
  66.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Change in SALT Score
Hide Description Severity of Alopecia Tool Score (SALT) calculation is based on a scoring system. The scalp is divided into the following 4 areas: 1) Vertex: 40% (0.4) of scalp surface area, 2) Right profile of scalp: 18% (0.18) of scalp surface area, 3) Left profile of scalp: 18% (0.18) of scalp surface area, and 4) Posterior aspect of scalp: 24% (0.24) of scalp surface area. The percentage of hair loss in any of these areas is the percentage hair loss multiplied by percent surface area of the scalp in that area. The SALT score is the sum of percentage of hair loss in all the above-mentioned areas, so a lower number indicates a better outcome. The reported SALT score range is from a minimum of 0 (no hair loss) to a maximum of 100 (100% hair loss).
Time Frame Baseline, 3 months and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ruxolitinib
Hide Arm/Group Description:

A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects.

Ruxolitinib: A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects.

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 65.8  (28.0)
3 months 24.8  (22.9)
6 months 7.3  (13.5)
2.Secondary Outcome
Title Percentage of Regrowth
Hide Description Mean percentage of regrowth was calculated at the end of treatment for all subjects.
Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ruxolitinib
Hide Arm/Group Description:

A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects.

Ruxolitinib: A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects.

No serious adverse effects noted

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: percentage of regrowth
68.9  (42.6)
Time Frame 9 months per patient
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ruxolitinib
Hide Arm/Group Description

A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects.

Ruxolitinib: A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects.

All-Cause Mortality
Ruxolitinib
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Ruxolitinib
Affected / at Risk (%) # Events
Total   0/12 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ruxolitinib
Affected / at Risk (%) # Events
Total   9/12 (75.00%)    
Blood and lymphatic system disorders   
low hemoglobin * 1  1/12 (8.33%)  1
Infections and infestations   
upper respiratory infection * 1  5/12 (41.67%)  7
pneumonia * 1  1/12 (8.33%)  1
Skin and subcutaneous tissue disorders   
acne * 1  2/12 (16.67%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
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
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Research Dermatology
Organization: Columbia University Dept of Dermatology
Phone: 2123056953
EMail: jc299@cumc.columbia.edu
Layout table for additonal information
Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT01950780    
Other Study ID Numbers: AAAL7102
First Submitted: September 23, 2013
First Posted: September 25, 2013
Results First Submitted: July 28, 2017
Results First Posted: May 7, 2019
Last Update Posted: May 7, 2019