Trial Outcomes & Findings for Intralesional Steroids in the Treatment of Alopecia Areata (NCT NCT01898806)

NCT ID: NCT01898806

Last Updated: 2019-06-06

Results Overview

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).

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 11 participants
• Primary outcome timeframe: Up to 48 weeks
• Results posted on: 2019-06-06

Participant Flow

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

Participant milestones

Measure	All Participants Includes individuals receiving intralesional triamcinolone 2.5, 5 or 10 mg/ml or intralesional placebo.
Overall Study STARTED	11
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	All Participants Includes individuals receiving intralesional triamcinolone 2.5, 5 or 10 mg/ml or intralesional placebo.
Overall Study Withdrawal by Subject	2
Overall Study Physician Decision	1

Baseline Characteristics

Intralesional Steroids in the Treatment of Alopecia Areata

Baseline characteristics by cohort

Measure	All Participants n=11 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 48 weeks

Population: 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.

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 weeks

Incidence and severity of adverse events (AEs) including the presence and degree of skin atrophy, as well as incidence of treatment-emergent laboratory abnormalities.

Outcome measures

Measure	All Participants n=8 Participants Includes individuals receiving intralesional triamcinolone 2.5, 5 or 10 mg/ml or intralesional placebo.
Number of Adverse Events	0 adverse events

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Grace Ulerio

Columbia University

Phone: 212-305-6953

Email: gu2102@cumc.columbia.edu

Results disclosure agreements

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