TriangleNCT03899259 · OUTCOME
Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Week 12
What was measured
SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes. SALT50 indicates at least a 50 % improvement from baseline in the SALT score.
Analysis population: All randomized participants who had evaluable data for this outcome measure.
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 | Source count |
|---|---|
| Placebo | 156 |
| 2 mg Baricitinib | 156 |
| 4 mg Baricitinib | 234 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 2.6 | Not reported | 1.0 | 6.4 | Not reported |
| 2 mg Baricitinib | 10.9 | Not reported | 6.9 | 16.8 | Not reported |
| 4 mg Baricitinib | 23.5 | Not reported | 18.5 | 29.3 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.58
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 13.60
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.005
- param Type
- Odds Ratio (OR)
- param Value
- 4.63
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 4.72
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 35.44
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- param Type
- Odds Ratio (OR)
- param Value
- 12.94
- statistical Method
- Regression, Logistic
Complete source fields
- analyses
- ci Lower Limit
- 1.58
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 13.60
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.005
- param Type
- Odds Ratio (OR)
- param Value
- 4.63
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 4.72
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 35.44
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- param Type
- Odds Ratio (OR)
- param Value
- 12.94
- statistical Method
- Regression, Logistic
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.0
- upper Limit
- 6.4
- value
- 2.6
- group Id
- OG001
- lower Limit
- 6.9
- upper Limit
- 16.8
- value
- 10.9
- group Id
- OG002
- lower Limit
- 18.5
- upper Limit
- 29.3
- value
- 23.5
- denoms
- counts
- group Id
- OG000
- value
- 156
- group Id
- OG001
- value
- 156
- group Id
- OG002
- value
- 234
- units
- Participants
- description
- SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes. SALT50 indicates at least a 50 % improvement from baseline in the SALT score.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received two placebo tablets matched to baricitinib, administered orally QD to maintain the blind.
- id
- OG000
- title
- Placebo
- 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
- 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
- NUMBER
- population Description
- All randomized participants who had evaluable data for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Week 12
- title
- Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice