Trial Outcomes & Findings for Evaluating Treatment Resistant Dermatitis TaroIIR (NCT NCT03050294)
NCT ID: NCT03050294
Last Updated: 2020-05-20
Results Overview
Investigator's Global Assessment of atopic dermatitis integrates all lesions for overall score. This measure is commonly used to quantify disease severity and most resembles assessments performed in the clinic setting. Score ranges from '0' = Clear to '5' = Very Severe Disease
COMPLETED
PHASE4
24 participants
1 week
2020-05-20
Participant Flow
Participant milestones
| Measure |
Control- Atopic Dermatitis
Participants with atopic dermatitis will receive desoximetasone and no calls.
Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily
|
Atopic Dermatitis Intervention
Participants with atopic dermatitis will receive desoximetasone and will be called twice each day, morning and evening, at predetermined times to go over their use of the medication.
Phone calls: Phone calls twice daily
Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily
|
Control- Psoriasis
Participants with psoriasis will receive desoximetasone and no calls.
Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily
|
Psoriasis Intervention
Participants with psoriasis will receive desoximetasone and will be called twice each day, morning and evening, at predetermined times to go over their use of the medication.
Phone calls: Phone calls twice daily
Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating Treatment Resistant Dermatitis TaroIIR
Baseline characteristics by cohort
| Measure |
Control- Atopic Dermatitis
n=6 Participants
Participants with atopic dermatitis will receive desoximetasone and no calls.
Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily
|
Atopic Dermatitis Intervention
n=6 Participants
Participants with atopic dermatitis will receive desoximetasone and will be called twice each day, morning and evening, at predetermined times to go over their use of the medication.
Phone calls: Phone calls twice daily
Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily
|
Control- Psoriasis
n=6 Participants
Participants with psoriasis will receive desoximetasone and no calls.
Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily
|
Psoriasis Intervention
n=6 Participants
Participants with psoriasis will receive desoximetasone and will be called twice each day, morning and evening, at predetermined times to go over their use of the medication.
Phone calls: Phone calls twice daily
Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
52.8 years
n=99 Participants
|
48 years
n=107 Participants
|
58.3 years
n=206 Participants
|
61.8 years
n=7 Participants
|
55.23 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 1 weekInvestigator's Global Assessment of atopic dermatitis integrates all lesions for overall score. This measure is commonly used to quantify disease severity and most resembles assessments performed in the clinic setting. Score ranges from '0' = Clear to '5' = Very Severe Disease
Outcome measures
| Measure |
Control- Atopic Dermatitis
n=6 Participants
Participants with atopic dermatitis will receive desoximetasone and no calls.
Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily
|
Atopic Dermatitis Intervention
n=6 Participants
Participants with atopic dermatitis will receive desoximetasone and will be called twice each day, morning and evening, at predetermined times to go over their use of the medication.
Phone calls: Phone calls twice daily
Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily
|
|---|---|---|
|
Investigator Global Assessment- Atopic Dermatitis
|
1.7 units on a scale
Standard Deviation 0.8
|
1.5 units on a scale
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: 2 weeksInvestigator's Global Assessment of atopic dermatitis integrates all lesions for overall score. This measure is commonly used to quantify disease severity and most resembles assessments performed in the clinic setting. Score ranges from '0' = Clear to '5' = Very Severe Disease
Outcome measures
| Measure |
Control- Atopic Dermatitis
n=6 Participants
Participants with atopic dermatitis will receive desoximetasone and no calls.
Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily
|
Atopic Dermatitis Intervention
n=6 Participants
Participants with atopic dermatitis will receive desoximetasone and will be called twice each day, morning and evening, at predetermined times to go over their use of the medication.
Phone calls: Phone calls twice daily
Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily
|
|---|---|---|
|
Investigator Global Assessment- Psoriasis
|
2.5 units on a scale
Standard Deviation 0.8
|
2.3 units on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 1 weekThe total lesion severity score measures scaling, erythema, and plaque elevation. The score range is 0-15, with higher scores denoting worse outcomes.
Outcome measures
| Measure |
Control- Atopic Dermatitis
n=6 Participants
Participants with atopic dermatitis will receive desoximetasone and no calls.
Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily
|
Atopic Dermatitis Intervention
n=6 Participants
Participants with atopic dermatitis will receive desoximetasone and will be called twice each day, morning and evening, at predetermined times to go over their use of the medication.
Phone calls: Phone calls twice daily
Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily
|
|---|---|---|
|
Total Lesion Severity Score- Atopic Dermatitis
|
3.8 units on a scale
Standard Deviation 2.5
|
4.7 units on a scale
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: 2 weeksThe total lesion severity score measures scaling, erythema, and plaque elevation. The score range is 0-15, with higher scores denoting worse outcomes.
Outcome measures
| Measure |
Control- Atopic Dermatitis
n=6 Participants
Participants with atopic dermatitis will receive desoximetasone and no calls.
Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily
|
Atopic Dermatitis Intervention
n=6 Participants
Participants with atopic dermatitis will receive desoximetasone and will be called twice each day, morning and evening, at predetermined times to go over their use of the medication.
Phone calls: Phone calls twice daily
Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily
|
|---|---|---|
|
Total Lesion Severity Score-Psoriasis
|
6.5 units on a scale
Standard Deviation 3.1
|
5.8 units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 1 weekEczema Area and Severity Index (EASI): Disease severity will be assessed by a physician with the Eczema Area and Severity Index (EASI). This measure is commonly used and well validated instrument of eczema severity. It is weighted for area in each of the four body regions (which differs for adults and children under 7) and scores erythema, excoriation, induration/papulation, and lichenification. The total scores range from 0-72. Higher scores represent more severe eczema.
Outcome measures
| Measure |
Control- Atopic Dermatitis
n=6 Participants
Participants with atopic dermatitis will receive desoximetasone and no calls.
Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily
|
Atopic Dermatitis Intervention
n=6 Participants
Participants with atopic dermatitis will receive desoximetasone and will be called twice each day, morning and evening, at predetermined times to go over their use of the medication.
Phone calls: Phone calls twice daily
Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily
|
|---|---|---|
|
Eczema Area and Severity Index- Atopic Dermatitis
|
3.1 units on a scale
Standard Deviation 5.1
|
1.2 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 1 weekThe Pruritus VAS is a scale consisting of a 10cm long line and a single question. The left end point represents "no itch" (score of 0) and the right end point the "worst imaginable itch" (score of 10).
Outcome measures
| Measure |
Control- Atopic Dermatitis
n=6 Participants
Participants with atopic dermatitis will receive desoximetasone and no calls.
Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily
|
Atopic Dermatitis Intervention
n=6 Participants
Participants with atopic dermatitis will receive desoximetasone and will be called twice each day, morning and evening, at predetermined times to go over their use of the medication.
Phone calls: Phone calls twice daily
Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily
|
|---|---|---|
|
Pruritus Visual Analog Scale- Atopic Dermatitis
|
1.1 units on a scale
Standard Deviation 2.0
|
1.2 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 2 weeksThe Pruritus VAS is a scale consisting of a 10cm long line and a single question. The left end point represents "no itch" (score of 0) and the right end point the "worst imaginable itch" (score of 10).
Outcome measures
| Measure |
Control- Atopic Dermatitis
n=6 Participants
Participants with atopic dermatitis will receive desoximetasone and no calls.
Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily
|
Atopic Dermatitis Intervention
n=6 Participants
Participants with atopic dermatitis will receive desoximetasone and will be called twice each day, morning and evening, at predetermined times to go over their use of the medication.
Phone calls: Phone calls twice daily
Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily
|
|---|---|---|
|
Pruritus Visual Analog Scale- Psoriasis
|
1.4 units on a scale
Standard Deviation 0.9
|
1.3 units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 2 weeksThe Psoriasis Area Severity Index (PASI) is an index used to express the severity of psoriasis. It combines the severity (erythema, induration and desquamation) and percentage of affected areas (head, arms, trunk, and legs). The severity of three clinical signs (erythema, induration and desquamation) are on a scale from 0 to 4 (from absent to very severe). An area and severity score for each region is calculated by multiplying the area score by the severity score. The score range is 0-72, with higher scores denoting worse outcomes.
Outcome measures
| Measure |
Control- Atopic Dermatitis
n=6 Participants
Participants with atopic dermatitis will receive desoximetasone and no calls.
Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily
|
Atopic Dermatitis Intervention
n=6 Participants
Participants with atopic dermatitis will receive desoximetasone and will be called twice each day, morning and evening, at predetermined times to go over their use of the medication.
Phone calls: Phone calls twice daily
Desoximetasone 0.25% spray: Desoximetasone 0.25% spray applied twice daily
|
|---|---|---|
|
Psoriasis Area and Severity Index
|
7.1 units on a scale
Standard Deviation 5.1
|
5.1 units on a scale
Standard Deviation 3.2
|
Adverse Events
Control- Atopic Dermatitis
Atopic Dermatitis Intervention
Control- Psoriasis
Psoriasis Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place