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NCT03899259 · OUTCOME

Change From Baseline in Skindex-16 AA Functioning Domain Score at Week 36

A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata · Source last updated 2026-04-07

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
LEAST_SQUARES_MEAN
Unit
score on a scale
Interval / dispersion
Standard Error
Time frame
Baseline, Week 36

What was measured

Skindex-16 AA was adapted from Skindex-16 for use among adults with alopecia areata. It examines the degree to which the participant is bothered by alopecia (hair loss) and associated symptoms. It is composed of 16 items grouped under 3 domains: Symptoms (4 items), Emotions (7 items), and Functioning (5 items). The score of each item ranges from 0 (never bothered) to 6 (always bothered). Symptoms domain score is sum of 4 items, range 0 to 24; Emotions domain score is sum of 7 items, range 0 to 42; Functioning score is sum of 5 items, range 0 to 30. Higher scores indicate a greater impact on quality of life. LS means was calculated using the ANCOVA model with geographic region, duration of current episode at Baseline (\<4 years vs. ≥ 4years), treatment group, and baseline value as fixed factors.

Analysis population: All randomized participants with baseline and at least one postbaseline Skindex-16 AA functioning domain score who had evaluable data for this outcome measure. The method used to handle missing data was modified last observation carried forward (mLOCF) which used the most recent nonmissing postbaseline assessment.

Groups in this outcome

Placebo

Participants received two placebo tablets matched to baricitinib, administered orally QD to maintain the blind.

2 mg Baricitinib

Participants received one 2 mg Baricitinib tablet administered orally QD and one placebo tablet administered orally QD to maintain the blind.

4 mg Baricitinib

Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Placebo146
2 mg Baricitinib147
4 mg Baricitinib227

Reported measurements

Source class 1
Values in score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Placebo-9.671.913Not reportedNot reportedNot reported
2 mg Baricitinib-14.051.925Not reportedNot reportedNot reported
4 mg Baricitinib-18.001.535Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    -9.65
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.88
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    2.680
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.103
    param Type
    Mean Difference (Final Values)
    param Value
    -4.38
    statistical Method
    ANCOVA
  2. ci Lower Limit
    -13.10
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -3.56
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    2.429
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    param Type
    Mean Difference (Final Values)
    param Value
    -8.33
    statistical Method
    ANCOVA
Complete source fields
analyses
  1. ci Lower Limit
    -9.65
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.88
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    2.680
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.103
    param Type
    Mean Difference (Final Values)
    param Value
    -4.38
    statistical Method
    ANCOVA
  2. ci Lower Limit
    -13.10
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -3.56
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    2.429
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    param Type
    Mean Difference (Final Values)
    param Value
    -8.33
    statistical Method
    ANCOVA
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.913
        value
        -9.67
      2. group Id
        OG001
        spread
        1.925
        value
        -14.05
      3. group Id
        OG002
        spread
        1.535
        value
        -18.00
denoms
  1. counts
    1. group Id
      OG000
      value
      146
    2. group Id
      OG001
      value
      147
    3. group Id
      OG002
      value
      227
    units
    Participants
description
Skindex-16 AA was adapted from Skindex-16 for use among adults with alopecia areata. It examines the degree to which the participant is bothered by alopecia (hair loss) and associated symptoms. It is composed of 16 items grouped under 3 domains: Symptoms (4 items), Emotions (7 items), and Functioning (5 items). The score of each item ranges from 0 (never bothered) to 6 (always bothered). Symptoms domain score is sum of 4 items, range 0 to 24; Emotions domain score is sum of 7 items, range 0 to 42; Functioning score is sum of 5 items, range 0 to 30. Higher scores indicate a greater impact on quality of life. LS means was calculated using the ANCOVA model with geographic region, duration of current episode at Baseline (\<4 years vs. ≥ 4years), treatment group, and baseline value as fixed factors.
dispersion Type
Standard Error
groups
  1. description
    Participants received two placebo tablets matched to baricitinib, administered orally QD to maintain the blind.
    id
    OG000
    title
    Placebo
  2. description
    Participants received one 2 mg Baricitinib tablet administered orally QD and one placebo tablet administered orally QD to maintain the blind.
    id
    OG001
    title
    2 mg Baricitinib
  3. description
    Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind.
    id
    OG002
    title
    4 mg Baricitinib
param Type
LEAST_SQUARES_MEAN
population Description
All randomized participants with baseline and at least one postbaseline Skindex-16 AA functioning domain score who had evaluable data for this outcome measure. The method used to handle missing data was modified last observation carried forward (mLOCF) which used the most recent nonmissing postbaseline assessment.
reporting Status
POSTED
time Frame
Baseline, Week 36
title
Change From Baseline in Skindex-16 AA Functioning Domain Score at Week 36
type
SECONDARY
unit Of Measure
score on a scale

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice