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Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants

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ClinicalTrials.gov Identifier: NCT02812342
Recruitment Status : Completed
First Posted : June 24, 2016
Results First Posted : October 10, 2018
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Alopecia Areata
Alopecia Totalis
Alopecia Universalis
Intervention Drug: Tofacitinib ointment
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tofacitinib Ointment
Hide Arm/Group Description

Patients with alopecia areata (AA) (with at least 2 patches of alopecia involving the scalp), alopecia totalis (AT) or alopecia universalis (AU) will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth between baseline and the end of study.

Tofacitinib ointment: Patients with AA (with at least 2 patches of alopecia involving the scalp), AT or AU will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth between baseline and end of study.

Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title Tofacitinib Ointment
Hide Arm/Group Description

Patients with AA (with at least 2 patches of alopecia involving the scalp), AT or AU will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth.

Tofacitinib ointment: Patients with AA (with at least 2 patches of alopecia involving the scalp), AT or AU will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth.

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
36.9  (14.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
4
  40.0%
Male
6
  60.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
  20.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
8
  80.0%
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 10 participants
10
SALT score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 10 participants
77.7  (32.3)
[1]
Measure Description: SALT score range is from 0 (no hair loss) to 100 (100% hair loss)
1.Primary Outcome
Title Percent Change in Severity of Alopecia Tool (SALT) Score
Hide Description SALT score range is from 0 (no hair loss) to 100 (100% hair loss). A positive percent change from baseline corresponds to a reduction in SALT score, and in this study study will be measured between baseline and 6 months.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tofacitinib Ointment
Hide Arm/Group Description:

Patients with AA (with at least 2 patches of alopecia involving the scalp), AT or AU will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth.

Tofacitinib ointment: Patients with AA (with at least 2 patches of alopecia involving the scalp), AT or AU will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth.

Overall Number of Participants Analyzed 10
Mean (Full Range)
Unit of Measure: percent change
10
(0 to 61)
2.Secondary Outcome
Title Treatment Response Assessed as the Number of Participants With Hair Regrowth
Hide Description Clinical photographs will be used to demonstrate presence or absence of hair regrowth. Presented is a count of people that did respond to treatment.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tofacitinib Ointment
Hide Arm/Group Description:

Patients with AA (with at least 2 patches of alopecia involving the scalp), AT or AU will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth.

Tofacitinib ointment: Patients with AA (with at least 2 patches of alopecia involving the scalp), AT or AU will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth.

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
3
  30.0%
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tofacitinib Ointment
Hide Arm/Group Description

Patients with AA (with at least 2 patches of alopecia involving the scalp), AT or AU will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth.

Tofacitinib ointment: Patients with AA (with at least 2 patches of alopecia involving the scalp), AT or AU will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth.

All-Cause Mortality
Tofacitinib Ointment
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Tofacitinib Ointment
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tofacitinib Ointment
Affected / at Risk (%)
Total   7/10 (70.00%) 
General disorders   
Headache   2/10 (20.00%) 
Infections and infestations   
Upper Respiratory Infection   4/10 (40.00%) 
Sinus Infection   1/10 (10.00%) 
Skin and subcutaneous tissue disorders   
Folliculitis   1/10 (10.00%) 
Scalp Skin Irritation   4/10 (40.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Brett King, MD, PhD, BA, Associate Professor of Dermatology
Organization: Yale Dermatology - Middlebury
Phone: (203) 737-4825
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02812342     History of Changes
Other Study ID Numbers: 1510016586
First Submitted: June 21, 2016
First Posted: June 24, 2016
Results First Submitted: September 12, 2018
Results First Posted: October 10, 2018
Last Update Posted: January 30, 2019