Trial Outcomes & Findings for Study of TER-101 Topical Ointment in Subjects With Atopic Dermatitis (NCT NCT04753034)
NCT ID: NCT04753034
Last Updated: 2022-07-26
Results Overview
EASI = Eczema Area and Severity Index, EASI combines the assessment of the severity of lesions and the the numerical area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). To calculate the EASI, the sum of the severity rating (0 to 3 with 3 being the most severe) for erythema, induration, lichenification, excoriation are multiplied with value of the area affected and with the percentage of the four body areas.
COMPLETED
PHASE2
63 participants
29 days
2022-07-26
Participant Flow
Participant milestones
| Measure |
TER-101
BID (twice daily) application
TER-101: Active Comparator
|
Vehicle
Vehicle ointment, BID (twice daily) application
Vehicle: Placebo Comparator
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
32
|
|
Overall Study
COMPLETED
|
29
|
31
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of TER-101 Topical Ointment in Subjects With Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
TER-101
n=31 Participants
BID (twice daily) application
TER-101: Active Comparator
|
Vehicle
n=32 Participants
Vehicle ointment, BID (twice daily) application
Vehicle: Placebo Comparator
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
21 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
4 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=99 Participants
|
32 participants
n=107 Participants
|
63 participants
n=206 Participants
|
|
EASI
|
7.97 Scores on a scale
STANDARD_DEVIATION 2.424 • n=99 Participants
|
8.47 Scores on a scale
STANDARD_DEVIATION 3.016 • n=107 Participants
|
8.22 Scores on a scale
STANDARD_DEVIATION 2.730 • n=206 Participants
|
|
Overall IGA score
2 - mild
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Overall IGA score
3 - moderate
|
23 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
WI-NRS
|
5.1 scores on a scale
STANDARD_DEVIATION 2.14 • n=99 Participants
|
5.5 scores on a scale
STANDARD_DEVIATION 2.58 • n=107 Participants
|
5.3 scores on a scale
STANDARD_DEVIATION 2.37 • n=206 Participants
|
|
Total body surface area
|
7.2 Percent of body surface area
STANDARD_DEVIATION 3.58 • n=99 Participants
|
7.8 Percent of body surface area
STANDARD_DEVIATION 3.83 • n=107 Participants
|
7.5 Percent of body surface area
STANDARD_DEVIATION 3.69 • n=206 Participants
|
PRIMARY outcome
Timeframe: 29 daysPopulation: All randomized participants who received at least 1 application of the study treatment and had at least 1 post-baseline efficacy assessment. The treatment group as assigned (randomized) was used for analyses.
EASI = Eczema Area and Severity Index, EASI combines the assessment of the severity of lesions and the the numerical area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). To calculate the EASI, the sum of the severity rating (0 to 3 with 3 being the most severe) for erythema, induration, lichenification, excoriation are multiplied with value of the area affected and with the percentage of the four body areas.
Outcome measures
| Measure |
TER-101
n=31 Participants
BID (twice daily) application
TER-101: Active Comparator
|
Vehicle
n=32 Participants
Vehicle ointment, BID (twice daily) application
Vehicle: Placebo Comparator
|
|---|---|---|
|
Percent Change in EASI From Baseline at Day 29
|
-47.37 percent change
Interval -67.088 to -27.653
|
-42.10 percent change
Interval -61.476 to -22.721
|
SECONDARY outcome
Timeframe: 15 daysPopulation: All randomized participants who received at least 1 application of the study treatment and had at least 1 post-baseline efficacy assessment. The treatment group as assigned (randomized) was used for analyses.
EASI combines the assessment of the severity of lesions and the area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). To calculate the EASI, the sum of the severity rating (0 to 3 with 3 being the most severe) for erythema, induration, lichenification, excoriation are multiplied with the numerical value of the area affected and with the percentage of the four body areas.
Outcome measures
| Measure |
TER-101
n=31 Participants
BID (twice daily) application
TER-101: Active Comparator
|
Vehicle
n=32 Participants
Vehicle ointment, BID (twice daily) application
Vehicle: Placebo Comparator
|
|---|---|---|
|
Changes in EASI Over Time
|
-35.96 percent
Interval -51.842 to -20.081
|
-39.24 percent
Interval -54.739 to -23.742
|
SECONDARY outcome
Timeframe: 29 DaysPopulation: All randomized participants who received at least 1 application of the study treatment and had at least 1 post-baseline efficacy assessment. The treatment group as assigned (randomized) was used for analyses.
IGA = Investigator Global Assessment (Scale 0 - 4) 0 = Clear 1. = Almost Clear 2. = Mild 3. = Moderate 4. = Severe
Outcome measures
| Measure |
TER-101
n=31 Participants
BID (twice daily) application
TER-101: Active Comparator
|
Vehicle
n=32 Participants
Vehicle ointment, BID (twice daily) application
Vehicle: Placebo Comparator
|
|---|---|---|
|
Change in IGA From Baseline Over Time
|
-0.7 score on a scale
Interval -3.0 to 1.0
|
-0.7 score on a scale
Interval -3.0 to 0.0
|
SECONDARY outcome
Timeframe: 29 daysPopulation: All randomized participants who received at least 1 application of the study treatment and had at least 1 post-baseline efficacy assessment. The treatment group as assigned (randomized) was used for analyses.
The WI-NRS asks subjects to report their worst itch (maximal intensity) during the last 24 hours on an 11-point NRS, ranging from 0 = "no itch at all" to 10 = "worst itch you can imagine".
Outcome measures
| Measure |
TER-101
n=31 Participants
BID (twice daily) application
TER-101: Active Comparator
|
Vehicle
n=32 Participants
Vehicle ointment, BID (twice daily) application
Vehicle: Placebo Comparator
|
|---|---|---|
|
Changes in Itch Over Time
|
-2.0 score on a scale
Interval -2.92 to -1.14
|
-1.2 score on a scale
Interval -2.0 to -0.32
|
SECONDARY outcome
Timeframe: 29 daysPopulation: All randomized participants who received at least 1 application of the study treatment. The treatment group for analyses was determined by the treatment received. If any TER-101 was applied, the participant was summarized under the TER-101 treatment group.
Sum of erythema, itch, and burning at the time of visit compared to baseline measured on a 0 - 3 scale for each component. A score of 0 indicates no erythema, itch or burning. Higher scores indicate worsening tolerability: 1 (mild), 2 (moderate), 3 (severe)
Outcome measures
| Measure |
TER-101
n=31 Participants
BID (twice daily) application
TER-101: Active Comparator
|
Vehicle
n=32 Participants
Vehicle ointment, BID (twice daily) application
Vehicle: Placebo Comparator
|
|---|---|---|
|
Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD
Baseline Erythema - none
|
17 Participants
|
15 Participants
|
|
Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD
Baseline Erythema - mild
|
0 Participants
|
2 Participants
|
|
Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD
Baseline Erythema - moderate
|
1 Participants
|
2 Participants
|
|
Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD
Baseline Erythema - Severe
|
0 Participants
|
0 Participants
|
|
Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD
Day 29 Erythema - none
|
15 Participants
|
14 Participants
|
|
Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD
Day 29 Erythema -mild
|
2 Participants
|
5 Participants
|
|
Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD
Day 29 Erythema - moderate
|
7 Participants
|
7 Participants
|
|
Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD
Day 29 Erythema - severe
|
0 Participants
|
0 Participants
|
|
Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD
Burning/Stinging baseline - none
|
22 Participants
|
26 Participants
|
|
Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD
Burning/Stinging baseline - mild
|
3 Participants
|
3 Participants
|
|
Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD
Burning/Stinging baseline - moderate
|
1 Participants
|
1 Participants
|
|
Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD
Burning/Stinging baseline - severe
|
0 Participants
|
0 Participants
|
|
Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD
Burning/Stinging D29 - none
|
20 Participants
|
24 Participants
|
|
Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD
Burning/Stinging D29 - mild
|
0 Participants
|
3 Participants
|
|
Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD
Burning/Stinging D29 - moderate
|
1 Participants
|
2 Participants
|
|
Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD
Burning/Stinging D29 - severe
|
1 Participants
|
0 Participants
|
|
Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD
Pruritis - Baseline - none
|
14 Participants
|
18 Participants
|
|
Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD
Pruritis - Baseline - mild
|
6 Participants
|
3 Participants
|
|
Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD
Pruritis - Baseline - moderate
|
2 Participants
|
2 Participants
|
|
Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD
Pruritis - Baseline - severe
|
1 Participants
|
0 Participants
|
|
Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD
Pruritis - D29 - none
|
13 Participants
|
15 Participants
|
|
Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD
Pruritis - D29 - mild
|
7 Participants
|
3 Participants
|
|
Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD
Pruritis - D29 - moderate
|
6 Participants
|
10 Participants
|
|
Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD
Pruritis - D29 - severe
|
0 Participants
|
0 Participants
|
Adverse Events
TER-101
Vehicle
Serious adverse events
| Measure |
TER-101
n=31 participants at risk
BID (twice daily) application
TER-101: Active Comparator
|
Vehicle
n=32 participants at risk
Vehicle ointment, BID (twice daily) application
Vehicle: Placebo Comparator
|
|---|---|---|
|
Infections and infestations
Kidney infection
|
3.2%
1/31 • 29 days
|
0.00%
0/32 • 29 days
|
|
Infections and infestations
Pneumonia
|
3.2%
1/31 • 29 days
|
0.00%
0/32 • 29 days
|
|
Infections and infestations
Urinary tract infection
|
3.2%
1/31 • 29 days
|
0.00%
0/32 • 29 days
|
Other adverse events
| Measure |
TER-101
n=31 participants at risk
BID (twice daily) application
TER-101: Active Comparator
|
Vehicle
n=32 participants at risk
Vehicle ointment, BID (twice daily) application
Vehicle: Placebo Comparator
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
3.2%
1/31 • 29 days
|
0.00%
0/32 • 29 days
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
3.2%
1/31 • 29 days
|
0.00%
0/32 • 29 days
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
3.2%
1/31 • 29 days
|
0.00%
0/32 • 29 days
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.2%
1/31 • 29 days
|
0.00%
0/32 • 29 days
|
|
General disorders
Application site pain
|
3.2%
1/31 • 29 days
|
3.1%
1/32 • 29 days
|
|
General disorders
Product intolerance
|
3.2%
1/31 • 29 days
|
0.00%
0/32 • 29 days
|
|
General disorders
Application site inflammation
|
0.00%
0/31 • 29 days
|
3.1%
1/32 • 29 days
|
|
General disorders
Hangover
|
0.00%
0/31 • 29 days
|
3.1%
1/32 • 29 days
|
|
Infections and infestations
Pilonidal cyst
|
3.2%
1/31 • 29 days
|
0.00%
0/32 • 29 days
|
|
Cardiac disorders
Bundle branch block right
|
3.2%
1/31 • 29 days
|
0.00%
0/32 • 29 days
|
|
Eye disorders
Eye irritation
|
3.2%
1/31 • 29 days
|
0.00%
0/32 • 29 days
|
|
Gastrointestinal disorders
Diarrhoea
|
3.2%
1/31 • 29 days
|
0.00%
0/32 • 29 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
1/31 • 29 days
|
0.00%
0/32 • 29 days
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
3.2%
1/31 • 29 days
|
0.00%
0/32 • 29 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After database lock, Institution/Investigator may publish trial data generated by Investigator at Institution upon the earlier of: (i) publication of primary Multicenter Publication; or (ii) 18 months after the Trial is completed, if a Multicenter Publication is not submitted by Sponsor for publication within such 18 month period; provided Sponsor has opportunity to review proposed publication or disclosure at least 60 days in advance of its submission to a journal, congress, panel, etc.
- Publication restrictions are in place
Restriction type: OTHER