Trial Outcomes & Findings for Topical Steroid Formulation and Wet Wraps (NCT NCT02680301)
NCT ID: NCT02680301
Last Updated: 2019-06-18
Results Overview
Change in atopic dermatitis based on physician global assessment scale: 0=clear; 1=almost clear; 2=mild disease; 3=moderate disease; 4=severe disease; 5- very severe disease Lower scores represent a better outcome.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
3-5 days
Results posted on
2019-06-18
Participant Flow
Participant milestones
| Measure |
Ointment Right/Cream Left
Pt. will use 0.1% triamcinolone OINTMENT with wet-wrap dressing on right side and 0.1% triamcinolone CREAM with wet-wrap dressing on left side of bilateral flare of atopic dermatitis twice daily as instructed.
0.1% triamcinolone CREAM: Patients will be asked to apply a topical steroid in a cream formulation to one extremity using the wet wrap technique.
0.1% triamcinolone OINTMENT: Patients will be asked to apply a topical steroid in a ointment formulation to one extremity using the wet wrap technique.
|
Ointment Left/Cream Right
Pt. will use 0.1% triamcinolone OINTMENT with wet-wrap dressing on left side and 0.1% triamcinolone CREAM with wet-wrap dressing on right side of bilateral flare of atopic dermatitis twice daily as instructed.
0.1% triamcinolone CREAM: Patients will be asked to apply a topical steroid in a cream formulation to one extremity using the wet wrap technique.
0.1% triamcinolone OINTMENT: Patients will be asked to apply a topical steroid in a ointment formulation to one extremity using the wet wrap technique.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
18
|
|
Overall Study
COMPLETED
|
22
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Topical Steroid Formulation and Wet Wraps
Baseline characteristics by cohort
| Measure |
Ointment Right/Cream Left
n=22 Participants
Pt. will use 0.1% triamcinolone OINTMENT with wet-wrap dressing on right side and 0.1% triamcinolone CREAM with wet-wrap dressing on left side of bilateral flare of atopic dermatitis twice daily as instructed.
0.1% triamcinolone CREAM: Patients will be asked to apply a topical steroid in a cream formulation to one extremity using the wet wrap technique.
0.1% triamcinolone OINTMENT: Patients will be asked to apply a topical steroid in a ointment formulation to one extremity using the wet wrap technique.
|
Ointment Left/Cream Right
n=17 Participants
Pt. will use 0.1% triamcinolone OINTMENT with wet-wrap dressing on left side and 0.1% triamcinolone CREAM with wet-wrap dressing on right side of bilateral flare of atopic dermatitis twice daily as instructed.
0.1% triamcinolone CREAM: Patients will be asked to apply a topical steroid in a cream formulation to one extremity using the wet wrap technique.
0.1% triamcinolone OINTMENT: Patients will be asked to apply a topical steroid in a ointment formulation to one extremity using the wet wrap technique.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
22 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
8.14 years
STANDARD_DEVIATION 3.88 • n=99 Participants
|
7.29 years
STANDARD_DEVIATION 3.27 • n=107 Participants
|
7.77 years
STANDARD_DEVIATION 3.61 • n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=99 Participants
|
17 participants
n=107 Participants
|
39 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3-5 daysPopulation: Patients ages 3 to 17 experiencing a symmetric, bilateral flare of atopic dermatitis.
Change in atopic dermatitis based on physician global assessment scale: 0=clear; 1=almost clear; 2=mild disease; 3=moderate disease; 4=severe disease; 5- very severe disease Lower scores represent a better outcome.
Outcome measures
| Measure |
Cream
n=39 Participants
Extremity that was treated with wet wraps and 0.1% triamcinolone in cream formulation
|
Ointment
n=39 Participants
Extremity that was treated with wet wraps and 0.1% triamcinolone in cream formulation
|
|---|---|---|
|
Efficacy of 0.1% Triamcinolone Containing Wet Wrap as an Ointment or as a Cream Formulation in Patients With Moderate to Severe Atopic Dermatitis
|
0.717 units on a scale
Standard Deviation 0.65
|
0.589 units on a scale
Standard Deviation 0.64
|
SECONDARY outcome
Timeframe: 3-5 daysPopulation: Patients ages 3 to 17 experiencing a symmetric, bilateral flare of atopic dermatitis.
Patient report of which topical steroid formulation was more effective
Outcome measures
| Measure |
Cream
n=39 Participants
Extremity that was treated with wet wraps and 0.1% triamcinolone in cream formulation
|
Ointment
Extremity that was treated with wet wraps and 0.1% triamcinolone in cream formulation
|
|---|---|---|
|
Patient Reported Efficacy
Cream
|
9 Participants
|
—
|
|
Patient Reported Efficacy
Ointment
|
16 Participants
|
—
|
|
Patient Reported Efficacy
No Difference
|
14 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3-5 daysPopulation: Patients ages 3 to 17 experiencing a symmetric, bilateral flare of atopic dermatitis.
Patient-reported adherence to wet-wrap protocol. Medication logs were used to evaluate adherence to the treatment protocol for both steroid formulations. Patents were determined to be adhering to the protocol if the number of wet-wraps for each study arm (cream or ointment) were the same. Because the total number of wraps varied between patients (the protocol required 1-2 wraps per day for 3-5 days), we reviewed medication logs to determine that each patient completed an equivalent number of ointment and cream wraps.
Outcome measures
| Measure |
Cream
n=39 Participants
Extremity that was treated with wet wraps and 0.1% triamcinolone in cream formulation
|
Ointment
Extremity that was treated with wet wraps and 0.1% triamcinolone in cream formulation
|
|---|---|---|
|
Number of Patients Adhering to Treatment Protocol
|
39 Participants
|
—
|
Adverse Events
Ointement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cream
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Katherine Sebastian
Seton Family of Hospitals/Ascension
Phone: 801-598-2484
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place