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Adrenal Function and Use of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) in Patients With Alopecia Areata

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ClinicalTrials.gov Identifier: NCT00484679
Recruitment Status : Completed
First Posted : June 11, 2007
Results First Posted : June 20, 2014
Last Update Posted : June 29, 2018
Sponsor:
Collaborator:
National Alopecia Areata Foundation
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Condition Alopecia Areata
Intervention Drug: Triamcinolone Acetonide 10 mg/mL (Kenalog-10)
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title (Kenalog-10) Intralesional Injections for Alopecia Areata
Hide Arm/Group Description Patients received Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections every 6 weeks for 6 months. Disease extent and efficacy was assessed along with safety studies involving regularly scheduled ACTH stimulation tests.
Period Title: Overall Study
Started 18
Completed 15
Not Completed 3
Reason Not Completed
Withdrawal by Subject             3
Arm/Group Title (Kenalog-10) Intralesional Injections for Alopecia Areata
Hide Arm/Group Description Patients received Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections every 6 weeks for 6 months. Disease extent and efficacy was assessed along with safety studies involving regularly scheduled ACTH stimulation tests.
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
15 completed the study and were used for analysis.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
  93.3%
>=65 years
1
   6.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
46.6  (14.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
10
  66.7%
Male
5
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Mean Change in Cortisol Levels From Baseline to Week 24
Hide Description Mean change in cortisol levels from baseline to week 24 after four triamcinolone acetonide 10 ml injections 6 weeks apart.
Time Frame baseline, week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed all treatment and follow-up visits
Arm/Group Title (Kenalog-10) Intralesional Injections for Alopecia Areata
Hide Arm/Group Description:
Patients received Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections every 6 weeks for 6 months. Disease extent and efficacy was assessed along with safety studies involving regularly scheduled ACTH stimulation tests.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.187  (6.019)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title (Kenalog-10) Intralesional Injections for Alopecia Areata
Hide Arm/Group Description Patients received Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections every 6 weeks for 6 months. Disease extent and efficacy was assessed along with safety studies involving regularly scheduled ACTH stimulation tests.
All-Cause Mortality
(Kenalog-10) Intralesional Injections for Alopecia Areata
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
(Kenalog-10) Intralesional Injections for Alopecia Areata
Affected / at Risk (%) # Events
Total   0/18 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
(Kenalog-10) Intralesional Injections for Alopecia Areata
Affected / at Risk (%) # Events
Total   17/18 (94.44%)    
Blood and lymphatic system disorders   
anemia *  1/18 (5.56%)  1
Ear and labyrinth disorders   
erythema of ear canal *  2/18 (11.11%)  2
Eye disorders   
conjunctivitis *  1/18 (5.56%)  1
pinguecula *  1/18 (5.56%)  1
Gastrointestinal disorders   
Diarrhea *  1/18 (5.56%)  1
General disorders   
Headaches *  4/18 (22.22%)  6
intermittant nose bleeds *  1/18 (5.56%)  1
tonsilar gland enlargement *  1/18 (5.56%)  1
Infections and infestations   
influenza *  1/18 (5.56%)  1
vaginal yeast infection *  1/18 (5.56%)  1
Musculoskeletal and connective tissue disorders   
Broken left elbow *  1/18 (5.56%)  1
nasal septal fracture *  1/18 (5.56%)  1
Nervous system disorders   
Restless leg syndrome *  1/18 (5.56%)  1
Psychiatric disorders   
feelings of sadness *  1/18 (5.56%)  3
Reproductive system and breast disorders   
Irregular periods *  2/18 (11.11%)  2
vaginal bleeding *  2/18 (11.11%)  2
Respiratory, thoracic and mediastinal disorders   
throat erythema *  2/18 (11.11%)  3
Pneumonia *  1/18 (5.56%)  1
Upper respiratory infection *  3/18 (16.67%)  3
Skin and subcutaneous tissue disorders   
acne *  1/18 (5.56%)  1
atrophy of scalp *  2/18 (11.11%)  2
benign keratosis *  1/18 (5.56%)  1
excoriations *  2/18 (11.11%)  2
facial flushing *  2/18 (11.11%)  3
folliculitis *  1/18 (5.56%)  1
increased number of telantascias along frontal hair line *  1/18 (5.56%)  1
Increase scalp hair loss *  1/18 (5.56%)  1
scale in ear canal *  1/18 (5.56%)  1
worsening ear dermatitis *  1/18 (5.56%)  1
xerotic skin *  1/18 (5.56%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Maria Hordinsky, MD
Organization: University of Minnesota
Phone: 612-624-5721
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00484679     History of Changes
Other Study ID Numbers: 0609M91989
First Submitted: June 8, 2007
First Posted: June 11, 2007
Results First Submitted: February 27, 2013
Results First Posted: June 20, 2014
Last Update Posted: June 29, 2018