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Intralesional Steroids in the Treatment of Alopecia Areata

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ClinicalTrials.gov Identifier: NCT01898806
Recruitment Status : Terminated (The PI left the Columbia University Medical Center. Study was not Completed.)
First Posted : July 12, 2013
Results First Posted : June 6, 2019
Last Update Posted : June 6, 2019
Sponsor:
Collaborator:
University of Minnesota
Information provided by (Responsible Party):
Columbia University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Alopecia Areata
Interventions Drug: Intralesional Triamcinolone 2.5 mg/ml
Drug: Intralesional Triamcinolone 5 mg/ml
Drug: Intralesional Triamcinolone 10 mg/ml
Drug: Intralesional Saline
Enrollment 11
Recruitment Details  
Pre-assignment Details Since the PI left the institution, the only data available at this time is information on the population enrolled that was provided to the IRB. Data was not provided to the IRB per arm, but rather, for as a collective whole
Arm/Group Title All Participants
Hide Arm/Group Description Includes individuals receiving intralesional triamcinolone 2.5, 5 or 10 mg/ml or intralesional placebo.
Period Title: Overall Study
Started 11
Completed 8
Not Completed 3
Reason Not Completed
Withdrawal by Subject             2
Physician Decision             1
Arm/Group Title All Participants
Hide Arm/Group Description Includes individuals receiving intralesional triamcinolone 2.5, 5 or 10 mg/ml or intralesional placebo. Since the PI left the institution, the only data available at this time is information on the population enrolled that was provided to the IRB. Data was not provided to the IRB per arm, but rather, for as a collective whole.
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
8
  72.7%
Male
3
  27.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   9.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   9.1%
White
6
  54.5%
More than one race
0
   0.0%
Unknown or Not Reported
3
  27.3%
1.Primary Outcome
Title Proportion of Responders
Hide Description Comparison of the proportion of responders in each group, with response defined as 50% change (% change NOT absolute change) in SALT score from baseline (50% regrowth at week 24).
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome since enrollment was incomplete and therefore could not be analyzed. The only information available is demographics data that was submitted to the IRB for the whole group, and not stratified per arm.
Arm/Group Title All Participants
Hide Arm/Group Description:
Includes individuals receiving intralesional triamcinolone 2.5, 5 or 10 mg/ml or intralesional placebo.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Number of Adverse Events
Hide Description Incidence and severity of adverse events (AEs) including the presence and degree of skin atrophy, as well as incidence of treatment-emergent laboratory abnormalities.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants
Hide Arm/Group Description:
Includes individuals receiving intralesional triamcinolone 2.5, 5 or 10 mg/ml or intralesional placebo.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: adverse events
0
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Participants
Hide Arm/Group Description Includes individuals receiving intralesional triamcinolone 2.5, 5 or 10 mg/ml or intralesional placebo. Data was not collected per arm, but rather, for as a collective whole.
All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
All Participants
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Participants
Affected / at Risk (%)
Total   0/8 (0.00%) 
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: Grace Ulerio
Organization: Columbia University
Phone: 212-305-6953
EMail: gu2102@cumc.columbia.edu
Layout table for additonal information
Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT01898806     History of Changes
Other Study ID Numbers: AAAI5852
First Submitted: July 10, 2013
First Posted: July 12, 2013
Results First Submitted: March 22, 2019
Results First Posted: June 6, 2019
Last Update Posted: June 6, 2019