Trial Outcomes & Findings for Benefit of Placebo and Different Concentrations of Triamcinolone Acetonide in Nail Psoriasis (NCT NCT03991936)
NCT ID: NCT03991936
Last Updated: 2024-03-27
Results Overview
The most effective concentration of intralesional triamcinolone acetonide will be determined between 0 mg/mL, 2.5 mg/mL, 5.0 mg/mL, 7.5 mg/mL, and 10.0 mg/mL.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
11 participants
Primary outcome timeframe
24 weeks (end of study)
Results posted on
2024-03-27
Participant Flow
Participants were recruited from one location in the United States
A total of 11 participants passed screening and were randomized.
Unit of analysis: Fingernails
Participant milestones
| Measure |
Placebo
Participants receive an intralesional injection of 0.1-0.2 mL of normal saline in one psoriatic fingernail once per 6 weeks until 24 weeks.
Placebos: Normal saline intralesional injection
|
Triamcinolone Acetonide 2.5 mg/mL
Participants receive an intralesional injection of 0.1-0.2 mL of 2.5 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Triamcinolone Acetonide 2.5 mg/mL: 2.5 mg/mL intralesional injection
|
Triamcinolone Acetonide 5.0 mg/mL
Participants receive an intralesional injection of 0.1-0.2 mL of 5.0 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Triamcinolone Acetonide 5.0 mg/mL: 5.0 mg/mL intralesional injection
|
Triamcinolone Acetonide 7.5 mg/mL
Participants receive an intralesional injection of 0.1-0.2 mL of 7.5 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Triamcinolone Acetonide 7.5 mg/mL: 7.5 mg/mL intralesional injection
|
Triamcinolone Acetonide 10 mg/mL
Participants receive an intralesional injection of 0.1-0.2 mL of 10 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Triamcinolone Acetonide 10 mg/mL: 10 mg/mL intralesional injection
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11 11
|
11 18
|
11 19
|
11 18
|
11 16
|
|
Overall Study
COMPLETED
|
10 10
|
10 16
|
10 17
|
10 16
|
10 14
|
|
Overall Study
NOT COMPLETED
|
1 1
|
1 2
|
1 2
|
1 2
|
1 2
|
Reasons for withdrawal
| Measure |
Placebo
Participants receive an intralesional injection of 0.1-0.2 mL of normal saline in one psoriatic fingernail once per 6 weeks until 24 weeks.
Placebos: Normal saline intralesional injection
|
Triamcinolone Acetonide 2.5 mg/mL
Participants receive an intralesional injection of 0.1-0.2 mL of 2.5 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Triamcinolone Acetonide 2.5 mg/mL: 2.5 mg/mL intralesional injection
|
Triamcinolone Acetonide 5.0 mg/mL
Participants receive an intralesional injection of 0.1-0.2 mL of 5.0 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Triamcinolone Acetonide 5.0 mg/mL: 5.0 mg/mL intralesional injection
|
Triamcinolone Acetonide 7.5 mg/mL
Participants receive an intralesional injection of 0.1-0.2 mL of 7.5 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Triamcinolone Acetonide 7.5 mg/mL: 7.5 mg/mL intralesional injection
|
Triamcinolone Acetonide 10 mg/mL
Participants receive an intralesional injection of 0.1-0.2 mL of 10 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Triamcinolone Acetonide 10 mg/mL: 10 mg/mL intralesional injection
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
1
|
1
|
Baseline Characteristics
The Nail Psoriasis Severity Index (NAPSI) measure is provided for units, and the number of fingernails included in each arm varies. Data is presented per arm, and an additional "Total" row is added.
Baseline characteristics by cohort
| Measure |
All Participants
n=82 Fingernails
Participants receive an intralesional injection of 0.1-0.2 mL of 2.5 mg/mL, 5 mg/mL, 7.5 mg/mL or 10 mg/mL intralesional triamcinolone acetonide, or normal saline in one psoriatic fingernail once per 6 weeks until 24 weeks.
|
|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 13 • n=11 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=11 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=11 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=11 Participants
|
|
Nail Psoriasis Qualify of Life, as Measured by Development and Validation of Nail Psoriasis Quality
|
7 percentage of NPQ10 score
n=11 Participants
|
|
Nail Psoriasis, as Measured by Nail Psoriasis Severity Index (NAPSI)
Triamcinolone acetonide 2.5 mg/mL
|
5.3 score on a scale
n=18 Fingernails • The Nail Psoriasis Severity Index (NAPSI) measure is provided for units, and the number of fingernails included in each arm varies. Data is presented per arm, and an additional "Total" row is added.
|
|
Nail Psoriasis, as Measured by Nail Psoriasis Severity Index (NAPSI)
Triamcinolone acetonide 5.0 mg/mL
|
4.76 score on a scale
n=19 Fingernails • The Nail Psoriasis Severity Index (NAPSI) measure is provided for units, and the number of fingernails included in each arm varies. Data is presented per arm, and an additional "Total" row is added.
|
|
Nail Psoriasis, as Measured by Nail Psoriasis Severity Index (NAPSI)
Triamcinolone acetonide 7.5 mg/mL
|
4.75 score on a scale
n=18 Fingernails • The Nail Psoriasis Severity Index (NAPSI) measure is provided for units, and the number of fingernails included in each arm varies. Data is presented per arm, and an additional "Total" row is added.
|
|
Nail Psoriasis, as Measured by Nail Psoriasis Severity Index (NAPSI)
Triamcinolone acetonide 10 mg/mL
|
5.0 score on a scale
n=16 Fingernails • The Nail Psoriasis Severity Index (NAPSI) measure is provided for units, and the number of fingernails included in each arm varies. Data is presented per arm, and an additional "Total" row is added.
|
|
Nail Psoriasis, as Measured by Nail Psoriasis Severity Index (NAPSI)
Placebo
|
4.7 score on a scale
n=11 Fingernails • The Nail Psoriasis Severity Index (NAPSI) measure is provided for units, and the number of fingernails included in each arm varies. Data is presented per arm, and an additional "Total" row is added.
|
|
Nail Psoriasis, as Measured by Nail Psoriasis Severity Index (NAPSI)
Total
|
4.9 score on a scale
n=82 Fingernails • The Nail Psoriasis Severity Index (NAPSI) measure is provided for units, and the number of fingernails included in each arm varies. Data is presented per arm, and an additional "Total" row is added.
|
PRIMARY outcome
Timeframe: 24 weeks (end of study)Population: Per protocol defined as participants completing 24-week follow-up visit
The most effective concentration of intralesional triamcinolone acetonide will be determined between 0 mg/mL, 2.5 mg/mL, 5.0 mg/mL, 7.5 mg/mL, and 10.0 mg/mL.
Outcome measures
| Measure |
All Groups
n=73 Fingernails
Participants receive an intralesional injection of 0.1-0.2 mL of 2.5 mg/mL, 5 mg/mL, 7.5 mg/mL, or 10 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
|
Triamcinolone Acetonide 2.5 mg/mL
Participants receive an intralesional injection of 0.1-0.2 mL of 2.5 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Triamcinolone Acetonide 2.5 mg/mL: 2.5 mg/mL intralesional injection
|
Triamcinolone Acetonide 5.0 mg/mL
Participants receive an intralesional injection of 0.1-0.2 mL of 5.0 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Triamcinolone Acetonide 5.0 mg/mL: 5.0 mg/mL intralesional injection
|
Triamcinolone Acetonide 7.5 mg/mL
Participants receive an intralesional injection of 0.1-0.2 mL of 7.5 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Triamcinolone Acetonide 7.5 mg/mL: 7.5 mg/mL intralesional injection
|
Triamcinolone Acetonide 10 mg/mL
Participants receive an intralesional injection of 0.1-0.2 mL of 10 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Triamcinolone Acetonide 10 mg/mL: 10 mg/mL intralesional injection
|
|---|---|---|---|---|---|
|
Lowest Effective Concentration of Intralesional Triamcinolone Acetonide for Nail Psoriasis
|
2.5 mg/mL
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 24 weeks (end of study)Population: Per protocol population, defined as participants completing 24-week follow-up visit
The Nail Psoriasis Severity Index (NAPSI) is used to evaluate nail psoriasis. Scores range from 0 to 8 with 0 indicating no nail psoriasis and higher scores indicating worsening nail psoriasis.
Outcome measures
| Measure |
All Groups
n=10 Fingernails
Participants receive an intralesional injection of 0.1-0.2 mL of 2.5 mg/mL, 5 mg/mL, 7.5 mg/mL, or 10 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
|
Triamcinolone Acetonide 2.5 mg/mL
n=16 Fingernails
Participants receive an intralesional injection of 0.1-0.2 mL of 2.5 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Triamcinolone Acetonide 2.5 mg/mL: 2.5 mg/mL intralesional injection
|
Triamcinolone Acetonide 5.0 mg/mL
n=17 Fingernails
Participants receive an intralesional injection of 0.1-0.2 mL of 5.0 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Triamcinolone Acetonide 5.0 mg/mL: 5.0 mg/mL intralesional injection
|
Triamcinolone Acetonide 7.5 mg/mL
n=16 Fingernails
Participants receive an intralesional injection of 0.1-0.2 mL of 7.5 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Triamcinolone Acetonide 7.5 mg/mL: 7.5 mg/mL intralesional injection
|
Triamcinolone Acetonide 10 mg/mL
n=14 Fingernails
Participants receive an intralesional injection of 0.1-0.2 mL of 10 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Triamcinolone Acetonide 10 mg/mL: 10 mg/mL intralesional injection
|
|---|---|---|---|---|---|
|
Change From Baseline in Nail Psoriasis, as Measured by Nail Psoriasis Severity Index (NAPSI)
|
-0.96 score on a scale
Interval -1.81 to -0.11
|
-3.96 score on a scale
Interval -4.64 to -3.27
|
-2.96 score on a scale
Interval -3.62 to -2.31
|
-3.53 score on a scale
Interval -4.2 to -2.85
|
-3.93 score on a scale
Interval -4.62 to -3.24
|
SECONDARY outcome
Timeframe: Baseline, 24 weeks (end of study)Population: Per protocol population, defined as participants completing the 24-week follow-up visit.
The NPQ10 comprises 10 questions gauging the impact of nail psoriasis on daily activities. Each response is scored from 0 to 2, resulting in a total score between 0 and 20, where higher values indicate a more significant impact. The final scores are converted to percentages, reflecting the proportion of questions answered by the patient. The obtained score correlates proportionally with the level of functional difficulty experienced, with 0% indicating no impairment and 100% indicating the worst possible impairment.
Outcome measures
| Measure |
All Groups
n=10 Participants
Participants receive an intralesional injection of 0.1-0.2 mL of 2.5 mg/mL, 5 mg/mL, 7.5 mg/mL, or 10 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
|
Triamcinolone Acetonide 2.5 mg/mL
Participants receive an intralesional injection of 0.1-0.2 mL of 2.5 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Triamcinolone Acetonide 2.5 mg/mL: 2.5 mg/mL intralesional injection
|
Triamcinolone Acetonide 5.0 mg/mL
Participants receive an intralesional injection of 0.1-0.2 mL of 5.0 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Triamcinolone Acetonide 5.0 mg/mL: 5.0 mg/mL intralesional injection
|
Triamcinolone Acetonide 7.5 mg/mL
Participants receive an intralesional injection of 0.1-0.2 mL of 7.5 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Triamcinolone Acetonide 7.5 mg/mL: 7.5 mg/mL intralesional injection
|
Triamcinolone Acetonide 10 mg/mL
Participants receive an intralesional injection of 0.1-0.2 mL of 10 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Triamcinolone Acetonide 10 mg/mL: 10 mg/mL intralesional injection
|
|---|---|---|---|---|---|
|
Change From Baseline in Nail Psoriasis Qualify of Life, as Measured by Development and Validation of Nail Psoriasis Quality of Life Scale (NPQ10)
|
4.5 percentage of NPQ10 score
Interval 0.0 to 15.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 weeks (end of study)Adverse events will only include those that are determined to be related to the study drug.
Outcome measures
| Measure |
All Groups
n=10 Participants
Participants receive an intralesional injection of 0.1-0.2 mL of 2.5 mg/mL, 5 mg/mL, 7.5 mg/mL, or 10 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
|
Triamcinolone Acetonide 2.5 mg/mL
n=10 Participants
Participants receive an intralesional injection of 0.1-0.2 mL of 2.5 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Triamcinolone Acetonide 2.5 mg/mL: 2.5 mg/mL intralesional injection
|
Triamcinolone Acetonide 5.0 mg/mL
n=10 Participants
Participants receive an intralesional injection of 0.1-0.2 mL of 5.0 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Triamcinolone Acetonide 5.0 mg/mL: 5.0 mg/mL intralesional injection
|
Triamcinolone Acetonide 7.5 mg/mL
n=10 Participants
Participants receive an intralesional injection of 0.1-0.2 mL of 7.5 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Triamcinolone Acetonide 7.5 mg/mL: 7.5 mg/mL intralesional injection
|
Triamcinolone Acetonide 10 mg/mL
n=10 Participants
Participants receive an intralesional injection of 0.1-0.2 mL of 10 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Triamcinolone Acetonide 10 mg/mL: 10 mg/mL intralesional injection
|
|---|---|---|---|---|---|
|
Number of Participants With at Least One Adverse Event
|
3 Participants
|
4 Participants
|
7 Participants
|
8 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Triamcinolone Acetonide 2.5 mg/mL
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Triamcinolone Acetonide 5.0 mg/mL
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Triamcinolone Acetonide 7.5 mg/mL
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Triamcinolone Acetonide 10 mg/mL
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=10 participants at risk
Participants receive an intralesional injection of 0.1-0.2 mL of normal saline in one psoriatic fingernail once per 6 weeks until 24 weeks.
Placebos: Normal saline intralesional injection
|
Triamcinolone Acetonide 2.5 mg/mL
n=10 participants at risk
Participants receive an intralesional injection of 0.1-0.2 mL of 2.5 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Triamcinolone Acetonide 2.5 mg/mL: 2.5 mg/mL intralesional injection
|
Triamcinolone Acetonide 5.0 mg/mL
n=10 participants at risk
Participants receive an intralesional injection of 0.1-0.2 mL of 5.0 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Triamcinolone Acetonide 5.0 mg/mL: 5.0 mg/mL intralesional injection
|
Triamcinolone Acetonide 7.5 mg/mL
n=10 participants at risk
Participants receive an intralesional injection of 0.1-0.2 mL of 7.5 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Triamcinolone Acetonide 7.5 mg/mL: 7.5 mg/mL intralesional injection
|
Triamcinolone Acetonide 10 mg/mL
n=10 participants at risk
Participants receive an intralesional injection of 0.1-0.2 mL of 10 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Triamcinolone Acetonide 10 mg/mL: 10 mg/mL intralesional injection
|
|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
20.0%
2/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
0.00%
0/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
20.0%
2/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
10.0%
1/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Subungual hematoma
|
0.00%
0/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
10.0%
1/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
10.0%
1/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
10.0%
1/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
0.00%
0/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Cuticle retraction
|
0.00%
0/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
10.0%
1/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
30.0%
3/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
40.0%
4/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
40.0%
4/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Longitudinal groove
|
0.00%
0/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
0.00%
0/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
0.00%
0/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
10.0%
1/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
0.00%
0/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Beau's line(s)
|
0.00%
0/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
10.0%
1/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
10.0%
1/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
10.0%
1/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
10.0%
1/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Erythronychia
|
0.00%
0/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
10.0%
1/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
10.0%
1/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
10.0%
1/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
20.0%
2/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Nail plate split
|
0.00%
0/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
0.00%
0/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
0.00%
0/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
0.00%
0/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
10.0%
1/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Nail plate concavity
|
0.00%
0/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
0.00%
0/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
0.00%
0/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
0.00%
0/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
10.0%
1/10 • 24 weeks
Adverse events are reported using fingernails as unit. Adverse events were recorded for 10 subjects because one participant was lost to follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place