Trial Outcomes & Findings for Adrenal Function and Use of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) in Patients With Alopecia Areata (NCT NCT00484679)

NCT ID: NCT00484679

Last Updated: 2018-06-29

Results Overview

Mean change in cortisol levels from baseline to week 24 after four triamcinolone acetonide 10 ml injections 6 weeks apart.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 18 participants
• Primary outcome timeframe: baseline, week 24
• Results posted on: 2018-06-29

Participant Flow

Participant milestones

Measure	(Kenalog-10) Intralesional Injections for Alopecia Areata 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 Study STARTED	18
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	(Kenalog-10) Intralesional Injections for Alopecia Areata 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 Study Withdrawal by Subject	3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	(Kenalog-10) Intralesional Injections for Alopecia Areata n=15 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	46.6 years STANDARD_DEVIATION 14.53 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, week 24

Population: Participants who completed all treatment and follow-up visits

Mean change in cortisol levels from baseline to week 24 after four triamcinolone acetonide 10 ml injections 6 weeks apart.

Outcome measures

Measure	(Kenalog-10) Intralesional Injections for Alopecia Areata n=15 Participants 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.
Mean Change in Cortisol Levels From Baseline to Week 24	0.187 mg/dL Standard Deviation 6.019

Adverse Events

(Kenalog-10) Intralesional Injections for Alopecia Areata

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	(Kenalog-10) Intralesional Injections for Alopecia Areata n=18 participants at risk 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.
Skin and subcutaneous tissue disorders acne	5.6% 1/18 • Number of events 1
Blood and lymphatic system disorders anemia	5.6% 1/18 • Number of events 1
Skin and subcutaneous tissue disorders atrophy of scalp	11.1% 2/18 • Number of events 2
Skin and subcutaneous tissue disorders benign keratosis	5.6% 1/18 • Number of events 1
Musculoskeletal and connective tissue disorders Broken left elbow	5.6% 1/18 • Number of events 1
Gastrointestinal disorders Diarrhea	5.6% 1/18 • Number of events 1
Ear and labyrinth disorders erythema of ear canal	11.1% 2/18 • Number of events 2
Skin and subcutaneous tissue disorders excoriations	11.1% 2/18 • Number of events 2
Skin and subcutaneous tissue disorders facial flushing	11.1% 2/18 • Number of events 3
Psychiatric disorders feelings of sadness	5.6% 1/18 • Number of events 3
Infections and infestations influenza	5.6% 1/18 • Number of events 1
Skin and subcutaneous tissue disorders folliculitis	5.6% 1/18 • Number of events 1
General disorders Headaches	22.2% 4/18 • Number of events 6
Skin and subcutaneous tissue disorders increased number of telantascias along frontal hair line	5.6% 1/18 • Number of events 1
Skin and subcutaneous tissue disorders Increase scalp hair loss	5.6% 1/18 • Number of events 1
Reproductive system and breast disorders Irregular periods	11.1% 2/18 • Number of events 2
Eye disorders conjunctivitis	5.6% 1/18 • Number of events 1
Respiratory, thoracic and mediastinal disorders throat erythema	11.1% 2/18 • Number of events 3
Musculoskeletal and connective tissue disorders nasal septal fracture	5.6% 1/18 • Number of events 1
General disorders intermittant nose bleeds	5.6% 1/18 • Number of events 1
Eye disorders pinguecula	5.6% 1/18 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pneumonia	5.6% 1/18 • Number of events 1
Nervous system disorders Restless leg syndrome	5.6% 1/18 • Number of events 1
Skin and subcutaneous tissue disorders scale in ear canal	5.6% 1/18 • Number of events 1
General disorders tonsilar gland enlargement	5.6% 1/18 • Number of events 1
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	16.7% 3/18 • Number of events 3
Reproductive system and breast disorders vaginal bleeding	11.1% 2/18 • Number of events 2
Infections and infestations vaginal yeast infection	5.6% 1/18 • Number of events 1
Skin and subcutaneous tissue disorders worsening ear dermatitis	5.6% 1/18 • Number of events 1
Skin and subcutaneous tissue disorders xerotic skin	5.6% 1/18 • Number of events 1

Additional Information

Maria Hordinsky, MD

University of Minnesota

Phone: 612-624-5721

Email: hordi001@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place