Trial Outcomes & Findings for Combined Restylane and Triamcinolone Acetonide Injections for the Treatment of Alopecia Areata (NCT NCT01797432)

Last Updated: 2021-01-12

Results Overview

The primary endpoint of evaluating the efficacy of administration of IL triamcinolone acetonide 10 mg/cc and Restylane® in the management of AA is the alopecia areata half head severity score (AAHHSS) comparing week 12 with baseline hair loss. Four discreet areas of the scalp are examined. The percent of terminal hair loss in each area is measured by visual estimation. Those percent figures are multiplied by the total area on one half of the scalp represented by the four respective areas. 1) Left parietal scalp (18% of area), right parietal scalp (18% of area), frontal scalp (40% of area), and occipital scalp (24% of area). Scores range from 0 to 50, with higher scores indicating more hair loss.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

12 weeks

Results posted on

2021-01-12

Participant Flow

Participant milestones

Participant milestones
Measure	Combined IL Kenalog and Restylane Injection of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on whole scalp and Restylane on half of scalp Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10): Intralesional injections of 4mLs Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on the whole scalp Restylane: Intralesional injections of 2mLs of Restylane on one side of the scalp
Overall Study STARTED	14
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Combined IL Kenalog and Restylane Injection of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on whole scalp and Restylane on half of scalp Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10): Intralesional injections of 4mLs Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on the whole scalp Restylane: Intralesional injections of 2mLs of Restylane on one side of the scalp
Overall Study Lost to Follow-up	1
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	1
Overall Study lived too far from study site	1

Baseline Characteristics

Combined Restylane and Triamcinolone Acetonide Injections for the Treatment of Alopecia Areata

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combined IL Kenalog and Restylane n=14 Participants Injection of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on whole scalp and Restylane on half of scalp Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10): Intralesional injections of 4mLs Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on the whole scalp Restylane: Intralesional injections of 2mLs of Restylane on one side of the scalp
Age, Categorical <=18 years	0 Participants n=113 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=113 Participants
Age, Categorical >=65 years	1 Participants n=113 Participants
Age, Continuous	41.43 years STANDARD_DEVIATION 18.98 • n=113 Participants
Sex: Female, Male Female	12 Participants n=113 Participants
Sex: Female, Male Male	2 Participants n=113 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=113 Participants
Race (NIH/OMB) Asian	0 Participants n=113 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=113 Participants
Race (NIH/OMB) Black or African American	0 Participants n=113 Participants
Race (NIH/OMB) White	13 Participants n=113 Participants
Race (NIH/OMB) More than one race	0 Participants n=113 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=113 Participants
Region of Enrollment United States	14 participants n=113 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	Combined IL Kenalog and Restylane n=10 Participants Injection of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on whole scalp and Restylane on half of scalp Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10): Intralesional injections of 4mLs Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on the whole scalp Restylane: Intralesional injections of 2mLs of Restylane on one side of the scalp
Change in Alopecia Areata Half Head Severity Score (AAHHSS) at 12 Weeks Compared to Baseline	-17.75 score on a scale Standard Deviation 23.36

SECONDARY outcome

Timeframe: 12 weeks

To assess the safety of IL triamcinolone acetonide 10 mg/cc and Restylane® in the management of AA.

Outcome measures

Outcome measures
Measure	Combined IL Kenalog and Restylane n=14 Participants Injection of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on whole scalp and Restylane on half of scalp Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10): Intralesional injections of 4mLs Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on the whole scalp Restylane: Intralesional injections of 2mLs of Restylane on one side of the scalp
Number of Adverse Events Reported by Subjects	25 adverse events

Adverse Events

Combined IL Kenalog and Restylane

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Combined IL Kenalog and Restylane n=14 participants at risk Injection of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on whole scalp and Restylane on half of scalp Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10): Intralesional injections of 4mLs Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on the whole scalp Restylane: Intralesional injections of 2mLs of Restylane on one side of the scalp
Respiratory, thoracic and mediastinal disorders Bronchial Infection	14.3% 2/14 • Number of events 3
Infections and infestations Shingles	7.1% 1/14 • Number of events 1
Renal and urinary disorders Bladder Infection	7.1% 1/14 • Number of events 1
General disorders Migraine Headache	7.1% 1/14 • Number of events 1
Immune system disorders Cold Sore	7.1% 1/14 • Number of events 1
General disorders Fatigue	7.1% 1/14 • Number of events 1
Immune system disorders Allergic Reaction	7.1% 1/14 • Number of events 1
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	14.3% 2/14 • Number of events 2
Skin and subcutaneous tissue disorders Pain at Injection Site	7.1% 1/14 • Number of events 1
Reproductive system and breast disorders Irregular Menstrual Cycle	7.1% 1/14 • Number of events 1
Infections and infestations Cold/flu	7.1% 1/14 • Number of events 1
General disorders Headache	7.1% 1/14 • Number of events 1
General disorders Difficulty Concentrating	7.1% 1/14 • Number of events 1
Gastrointestinal disorders Traveler's Diarrhea	7.1% 1/14 • Number of events 1
Skin and subcutaneous tissue disorders Acne	7.1% 1/14 • Number of events 1
Gastrointestinal disorders Vomiting	7.1% 1/14 • Number of events 2
Skin and subcutaneous tissue disorders Eczema	7.1% 1/14 • Number of events 2
Immune system disorders Hives	7.1% 1/14 • Number of events 1
Injury, poisoning and procedural complications Bump on Head	7.1% 1/14 • Number of events 1

Additional Information

Maria Hordinsky, MD

University of Minnesota

Phone: 612-625-6118

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place