Trial Outcomes & Findings for Steroid-reducing Effects of Crisaborole (NCT NCT03832010)
NCT ID: NCT03832010
Last Updated: 2024-07-19
Results Overview
Steroid usage measured in medication weight (grams)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
24 participants
Primary outcome timeframe
Day 30
Results posted on
2024-07-19
Participant Flow
Participant milestones
| Measure |
Crisaborole
Crisaborole is chosen because it is the newest non-steroid FDA-approved prescription topical medication for treatment of mild to moderate AD in children 2 years of age and older. The FDA-approved dosage is application of a thin layer twice daily to affected areas.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
Crisaborole: Participants will be instructed to apply crisaborole to affected areas with eczema.
In the crisaborole group, the parents will be provided with crisaborole (with unidentifiable packaging) with refills as needed. As for twice daily topical corticosteroid (TCS), triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment will be provided, with refills as needed. Aquaphor is to be applied for maintenance. Crisaborole will be used as the first-line agent for AD lesions. TCS will be used as the second-line agent for AD lesions.
|
Vehicle
Crisaborole vehicle is chosen because this contains only the inactive ingredients found in crisaborole, to serve as placebo.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the vehicle group, parents will be provided vehicle (non-medicated ointment) with unidentifiable packaging, with refills as needed. They will also have triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment provided, with refills as needed. They will be provided identical instructions to the crisaborole group with regard to usage of the vehicle and TCS.
|
Control
Aquaphor is chosen because this is a skin moisturizer which is routinely used by patients with AD.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the control group, parent(s) will be provided control (Aquaphor) in unidentifiable packaging, with refills as needed. They will also be provided triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment, with refills as needed. They will be given identical instructions to the crisaborole and vehicle groups with regard to usage of TCS.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
9
|
|
Overall Study
COMPLETED
|
4
|
5
|
8
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
1
|
Reasons for withdrawal
| Measure |
Crisaborole
Crisaborole is chosen because it is the newest non-steroid FDA-approved prescription topical medication for treatment of mild to moderate AD in children 2 years of age and older. The FDA-approved dosage is application of a thin layer twice daily to affected areas.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
Crisaborole: Participants will be instructed to apply crisaborole to affected areas with eczema.
In the crisaborole group, the parents will be provided with crisaborole (with unidentifiable packaging) with refills as needed. As for twice daily topical corticosteroid (TCS), triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment will be provided, with refills as needed. Aquaphor is to be applied for maintenance. Crisaborole will be used as the first-line agent for AD lesions. TCS will be used as the second-line agent for AD lesions.
|
Vehicle
Crisaborole vehicle is chosen because this contains only the inactive ingredients found in crisaborole, to serve as placebo.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the vehicle group, parents will be provided vehicle (non-medicated ointment) with unidentifiable packaging, with refills as needed. They will also have triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment provided, with refills as needed. They will be provided identical instructions to the crisaborole group with regard to usage of the vehicle and TCS.
|
Control
Aquaphor is chosen because this is a skin moisturizer which is routinely used by patients with AD.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the control group, parent(s) will be provided control (Aquaphor) in unidentifiable packaging, with refills as needed. They will also be provided triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment, with refills as needed. They will be given identical instructions to the crisaborole and vehicle groups with regard to usage of TCS.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
1
|
Baseline Characteristics
Steroid-reducing Effects of Crisaborole
Baseline characteristics by cohort
| Measure |
Crisaborole
n=8 Participants
Participants will be instructed to apply emollient, topical steroid, and or crisaborole (blinded) to affected areas with eczema.
Crisaborole: Participants will be instructed to apply crisaborole to affected areas with eczema.
Hydrocortisone Ointment: Participants will be instructed to apply hydrocortisone to affected areas with eczema on face, armpits or groin.
Triamcinolone ointment: Participants will be instructed to apply triamcinolone to affected areas on the body excluding face, armpits or groin.
Aquaphor: Participants will be instructed to moisturize all over the body with Aquaphor.
|
Vehicle
n=7 Participants
Participants will be instructed to apply emollient, topical steroid, and or vehicle (blinded) to affected areas with eczema.
Hydrocortisone Ointment: Participants will be instructed to apply hydrocortisone to affected areas with eczema on face, armpits or groin.
Triamcinolone ointment: Participants will be instructed to apply triamcinolone to affected areas on the body excluding face, armpits or groin.
Aquaphor: Participants will be instructed to moisturize all over the body with Aquaphor.
|
Control
n=9 Participants
Participants will be instructed to apply emollient, topical steroid, and or emollient (blinded) to affected areas with eczema.
Hydrocortisone Ointment: Participants will be instructed to apply hydrocortisone to affected areas with eczema on face, armpits or groin.
Triamcinolone ointment: Participants will be instructed to apply triamcinolone to affected areas on the body excluding face, armpits or groin.
Aquaphor: Participants will be instructed to moisturize all over the body with Aquaphor.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
7.88 years
STANDARD_DEVIATION 5.17 • n=5 Participants
|
7.86 years
STANDARD_DEVIATION 3.93 • n=7 Participants
|
6.56 years
STANDARD_DEVIATION 3.81 • n=5 Participants
|
7.375 years
STANDARD_DEVIATION 4.20 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 30Population: 3 withdrew, 7 lost to followup
Steroid usage measured in medication weight (grams)
Outcome measures
| Measure |
Crisaborole
n=4 Participants
Crisaborole is chosen because it is the newest non-steroid FDA-approved prescription topical medication for treatment of mild to moderate AD in children 2 years of age and older. The FDA-approved dosage is application of a thin layer twice daily to affected areas.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
Crisaborole: Participants will be instructed to apply crisaborole to affected areas with eczema.
In the crisaborole group, the parents will be provided with crisaborole (with unidentifiable packaging) with refills as needed. As for twice daily topical corticosteroid (TCS), triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment will be provided, with refills as needed. Aquaphor is to be applied for maintenance. Crisaborole will be used as the first-line agent for AD lesions. TCS will be used as the second-line agent for AD lesions.
|
Vehicle
n=5 Participants
Crisaborole vehicle is chosen because this contains only the inactive ingredients found in crisaborole, to serve as placebo.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the vehicle group, parents will be provided vehicle (non-medicated ointment) with unidentifiable packaging, with refills as needed. They will also have triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment provided, with refills as needed. They will be provided identical instructions to the crisaborole group with regard to usage of the vehicle and TCS.
|
Control
n=5 Participants
Aquaphor is chosen because this is a skin moisturizer which is routinely used by patients with AD.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the control group, parent(s) will be provided control (Aquaphor) in unidentifiable packaging, with refills as needed. They will also be provided triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment, with refills as needed. They will be given identical instructions to the crisaborole and vehicle groups with regard to usage of TCS.
|
|---|---|---|---|
|
Steroid Usage Quantity
|
7.27 grams
Standard Deviation 10.00
|
10.78 grams
Standard Deviation 20.77
|
8.22 grams
Standard Deviation 10.39
|
PRIMARY outcome
Timeframe: Day 90Population: 3 withdrew, 9 lost to followup
Steroid usage measured in medication weight (grams)
Outcome measures
| Measure |
Crisaborole
n=2 Participants
Crisaborole is chosen because it is the newest non-steroid FDA-approved prescription topical medication for treatment of mild to moderate AD in children 2 years of age and older. The FDA-approved dosage is application of a thin layer twice daily to affected areas.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
Crisaborole: Participants will be instructed to apply crisaborole to affected areas with eczema.
In the crisaborole group, the parents will be provided with crisaborole (with unidentifiable packaging) with refills as needed. As for twice daily topical corticosteroid (TCS), triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment will be provided, with refills as needed. Aquaphor is to be applied for maintenance. Crisaborole will be used as the first-line agent for AD lesions. TCS will be used as the second-line agent for AD lesions.
|
Vehicle
n=4 Participants
Crisaborole vehicle is chosen because this contains only the inactive ingredients found in crisaborole, to serve as placebo.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the vehicle group, parents will be provided vehicle (non-medicated ointment) with unidentifiable packaging, with refills as needed. They will also have triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment provided, with refills as needed. They will be provided identical instructions to the crisaborole group with regard to usage of the vehicle and TCS.
|
Control
n=6 Participants
Aquaphor is chosen because this is a skin moisturizer which is routinely used by patients with AD.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the control group, parent(s) will be provided control (Aquaphor) in unidentifiable packaging, with refills as needed. They will also be provided triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment, with refills as needed. They will be given identical instructions to the crisaborole and vehicle groups with regard to usage of TCS.
|
|---|---|---|---|
|
Steroid Usage Quantity
|
37.82 grams
Standard Deviation 27.49
|
16.15 grams
Standard Deviation 18.79
|
5.43 grams
Standard Deviation 11.13
|
PRIMARY outcome
Timeframe: Day 30Steroid usage measured in diary entries. Weekly average frequency of steroid use is reported.
Outcome measures
| Measure |
Crisaborole
n=5 Participants
Crisaborole is chosen because it is the newest non-steroid FDA-approved prescription topical medication for treatment of mild to moderate AD in children 2 years of age and older. The FDA-approved dosage is application of a thin layer twice daily to affected areas.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
Crisaborole: Participants will be instructed to apply crisaborole to affected areas with eczema.
In the crisaborole group, the parents will be provided with crisaborole (with unidentifiable packaging) with refills as needed. As for twice daily topical corticosteroid (TCS), triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment will be provided, with refills as needed. Aquaphor is to be applied for maintenance. Crisaborole will be used as the first-line agent for AD lesions. TCS will be used as the second-line agent for AD lesions.
|
Vehicle
n=5 Participants
Crisaborole vehicle is chosen because this contains only the inactive ingredients found in crisaborole, to serve as placebo.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the vehicle group, parents will be provided vehicle (non-medicated ointment) with unidentifiable packaging, with refills as needed. They will also have triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment provided, with refills as needed. They will be provided identical instructions to the crisaborole group with regard to usage of the vehicle and TCS.
|
Control
n=8 Participants
Aquaphor is chosen because this is a skin moisturizer which is routinely used by patients with AD.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the control group, parent(s) will be provided control (Aquaphor) in unidentifiable packaging, with refills as needed. They will also be provided triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment, with refills as needed. They will be given identical instructions to the crisaborole and vehicle groups with regard to usage of TCS.
|
|---|---|---|---|
|
Steroid Usage Frequency
|
1.81 steroids used per week
Standard Deviation 1.41
|
1.27 steroids used per week
Standard Deviation 1.21
|
1.85 steroids used per week
Standard Deviation 1.09
|
PRIMARY outcome
Timeframe: Day 90Population: Participants lost to follow-up in recording diaries, data not collected.
Steroid usage measured in diary entries. Weekly average frequency of steroid use is reported.
Outcome measures
| Measure |
Crisaborole
n=3 Participants
Crisaborole is chosen because it is the newest non-steroid FDA-approved prescription topical medication for treatment of mild to moderate AD in children 2 years of age and older. The FDA-approved dosage is application of a thin layer twice daily to affected areas.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
Crisaborole: Participants will be instructed to apply crisaborole to affected areas with eczema.
In the crisaborole group, the parents will be provided with crisaborole (with unidentifiable packaging) with refills as needed. As for twice daily topical corticosteroid (TCS), triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment will be provided, with refills as needed. Aquaphor is to be applied for maintenance. Crisaborole will be used as the first-line agent for AD lesions. TCS will be used as the second-line agent for AD lesions.
|
Vehicle
n=5 Participants
Crisaborole vehicle is chosen because this contains only the inactive ingredients found in crisaborole, to serve as placebo.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the vehicle group, parents will be provided vehicle (non-medicated ointment) with unidentifiable packaging, with refills as needed. They will also have triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment provided, with refills as needed. They will be provided identical instructions to the crisaborole group with regard to usage of the vehicle and TCS.
|
Control
n=8 Participants
Aquaphor is chosen because this is a skin moisturizer which is routinely used by patients with AD.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the control group, parent(s) will be provided control (Aquaphor) in unidentifiable packaging, with refills as needed. They will also be provided triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment, with refills as needed. They will be given identical instructions to the crisaborole and vehicle groups with regard to usage of TCS.
|
|---|---|---|---|
|
Steroid Usage Frequency
|
2.74 steroids used per week
Standard Deviation 3.62
|
1.71 steroids used per week
Standard Deviation 1.80
|
1.38 steroids used per week
Standard Deviation 1.11
|
SECONDARY outcome
Timeframe: Day 0Clinical assessment using SCORAD score: minimum score = 0, maximum score = 103. Highest score corresponds with highest severity of eczema. Lowest score corresponds with lowest severity of eczema.
Outcome measures
| Measure |
Crisaborole
n=8 Participants
Crisaborole is chosen because it is the newest non-steroid FDA-approved prescription topical medication for treatment of mild to moderate AD in children 2 years of age and older. The FDA-approved dosage is application of a thin layer twice daily to affected areas.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
Crisaborole: Participants will be instructed to apply crisaborole to affected areas with eczema.
In the crisaborole group, the parents will be provided with crisaborole (with unidentifiable packaging) with refills as needed. As for twice daily topical corticosteroid (TCS), triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment will be provided, with refills as needed. Aquaphor is to be applied for maintenance. Crisaborole will be used as the first-line agent for AD lesions. TCS will be used as the second-line agent for AD lesions.
|
Vehicle
n=7 Participants
Crisaborole vehicle is chosen because this contains only the inactive ingredients found in crisaborole, to serve as placebo.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the vehicle group, parents will be provided vehicle (non-medicated ointment) with unidentifiable packaging, with refills as needed. They will also have triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment provided, with refills as needed. They will be provided identical instructions to the crisaborole group with regard to usage of the vehicle and TCS.
|
Control
n=9 Participants
Aquaphor is chosen because this is a skin moisturizer which is routinely used by patients with AD.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the control group, parent(s) will be provided control (Aquaphor) in unidentifiable packaging, with refills as needed. They will also be provided triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment, with refills as needed. They will be given identical instructions to the crisaborole and vehicle groups with regard to usage of TCS.
|
|---|---|---|---|
|
Eczema Severity as Assessed by SCORing Atopic Dermatitis (SCORAD) Score
|
29.15 score on a scale
Standard Deviation 10.79
|
28.75 score on a scale
Standard Deviation 9.68
|
29.04 score on a scale
Standard Deviation 14.43
|
SECONDARY outcome
Timeframe: Day 30Population: There were some lost-to-follow up after Day 0.
Clinical assessment using SCORAD score: minimum score = 0, maximum score = 103. Higher score corresponds with increased severity of eczema. Lowest score corresponds with lowest severity of eczema.
Outcome measures
| Measure |
Crisaborole
n=5 Participants
Crisaborole is chosen because it is the newest non-steroid FDA-approved prescription topical medication for treatment of mild to moderate AD in children 2 years of age and older. The FDA-approved dosage is application of a thin layer twice daily to affected areas.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
Crisaborole: Participants will be instructed to apply crisaborole to affected areas with eczema.
In the crisaborole group, the parents will be provided with crisaborole (with unidentifiable packaging) with refills as needed. As for twice daily topical corticosteroid (TCS), triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment will be provided, with refills as needed. Aquaphor is to be applied for maintenance. Crisaborole will be used as the first-line agent for AD lesions. TCS will be used as the second-line agent for AD lesions.
|
Vehicle
n=5 Participants
Crisaborole vehicle is chosen because this contains only the inactive ingredients found in crisaborole, to serve as placebo.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the vehicle group, parents will be provided vehicle (non-medicated ointment) with unidentifiable packaging, with refills as needed. They will also have triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment provided, with refills as needed. They will be provided identical instructions to the crisaborole group with regard to usage of the vehicle and TCS.
|
Control
n=7 Participants
Aquaphor is chosen because this is a skin moisturizer which is routinely used by patients with AD.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the control group, parent(s) will be provided control (Aquaphor) in unidentifiable packaging, with refills as needed. They will also be provided triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment, with refills as needed. They will be given identical instructions to the crisaborole and vehicle groups with regard to usage of TCS.
|
|---|---|---|---|
|
Eczema Severity Assessed by SCORAD Score
|
26.88 score on a scale
Standard Deviation 9.64
|
25.40 score on a scale
Standard Deviation 17.49
|
22.66 score on a scale
Standard Deviation 8.21
|
SECONDARY outcome
Timeframe: Day 90Clinical assessment using SCORAD score: minimum score = 0, maximum score = 103. Higher score corresponds with increased severity of eczema. Lowest score corresponds with lowest severity of eczema.
Outcome measures
| Measure |
Crisaborole
n=4 Participants
Crisaborole is chosen because it is the newest non-steroid FDA-approved prescription topical medication for treatment of mild to moderate AD in children 2 years of age and older. The FDA-approved dosage is application of a thin layer twice daily to affected areas.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
Crisaborole: Participants will be instructed to apply crisaborole to affected areas with eczema.
In the crisaborole group, the parents will be provided with crisaborole (with unidentifiable packaging) with refills as needed. As for twice daily topical corticosteroid (TCS), triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment will be provided, with refills as needed. Aquaphor is to be applied for maintenance. Crisaborole will be used as the first-line agent for AD lesions. TCS will be used as the second-line agent for AD lesions.
|
Vehicle
n=5 Participants
Crisaborole vehicle is chosen because this contains only the inactive ingredients found in crisaborole, to serve as placebo.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the vehicle group, parents will be provided vehicle (non-medicated ointment) with unidentifiable packaging, with refills as needed. They will also have triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment provided, with refills as needed. They will be provided identical instructions to the crisaborole group with regard to usage of the vehicle and TCS.
|
Control
n=8 Participants
Aquaphor is chosen because this is a skin moisturizer which is routinely used by patients with AD.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the control group, parent(s) will be provided control (Aquaphor) in unidentifiable packaging, with refills as needed. They will also be provided triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment, with refills as needed. They will be given identical instructions to the crisaborole and vehicle groups with regard to usage of TCS.
|
|---|---|---|---|
|
Eczema Severity Assessed by SCORAD Score
|
25.78 score on a scale
Standard Deviation 7.90
|
17.20 score on a scale
Standard Deviation 8.74
|
18.99 score on a scale
Standard Deviation 10.66
|
SECONDARY outcome
Timeframe: Day 0Population: Some participants were lost to follow-up, data not collected.
Children's Dermatology Life Quality Index (ages 15 or younger). The minimum score is 0, maximum score is 30. The highest score corresponds with most severe impairment of quality of life. The lowest score corresponds with lowest impairment of quality of life.
Outcome measures
| Measure |
Crisaborole
n=6 Participants
Crisaborole is chosen because it is the newest non-steroid FDA-approved prescription topical medication for treatment of mild to moderate AD in children 2 years of age and older. The FDA-approved dosage is application of a thin layer twice daily to affected areas.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
Crisaborole: Participants will be instructed to apply crisaborole to affected areas with eczema.
In the crisaborole group, the parents will be provided with crisaborole (with unidentifiable packaging) with refills as needed. As for twice daily topical corticosteroid (TCS), triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment will be provided, with refills as needed. Aquaphor is to be applied for maintenance. Crisaborole will be used as the first-line agent for AD lesions. TCS will be used as the second-line agent for AD lesions.
|
Vehicle
n=6 Participants
Crisaborole vehicle is chosen because this contains only the inactive ingredients found in crisaborole, to serve as placebo.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the vehicle group, parents will be provided vehicle (non-medicated ointment) with unidentifiable packaging, with refills as needed. They will also have triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment provided, with refills as needed. They will be provided identical instructions to the crisaborole group with regard to usage of the vehicle and TCS.
|
Control
n=9 Participants
Aquaphor is chosen because this is a skin moisturizer which is routinely used by patients with AD.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the control group, parent(s) will be provided control (Aquaphor) in unidentifiable packaging, with refills as needed. They will also be provided triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment, with refills as needed. They will be given identical instructions to the crisaborole and vehicle groups with regard to usage of TCS.
|
|---|---|---|---|
|
Quality of Life for Participant as Assessed by Children's Dermatology Life Quality Index
|
10.67 score on a scale
Standard Deviation 5.65
|
4.67 score on a scale
Standard Deviation 4.50
|
8.89 score on a scale
Standard Deviation 5.99
|
SECONDARY outcome
Timeframe: Day 30Population: Some participants were lost to follow-up, data not collected.
Children's Dermatology Life Quality Index (ages 15 or younger). The minimum score is 0, maximum score is 30. The highest score corresponds with most severe impairment of quality of life. The lowest score corresponds with lowest impairment of quality of life.
Outcome measures
| Measure |
Crisaborole
n=4 Participants
Crisaborole is chosen because it is the newest non-steroid FDA-approved prescription topical medication for treatment of mild to moderate AD in children 2 years of age and older. The FDA-approved dosage is application of a thin layer twice daily to affected areas.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
Crisaborole: Participants will be instructed to apply crisaborole to affected areas with eczema.
In the crisaborole group, the parents will be provided with crisaborole (with unidentifiable packaging) with refills as needed. As for twice daily topical corticosteroid (TCS), triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment will be provided, with refills as needed. Aquaphor is to be applied for maintenance. Crisaborole will be used as the first-line agent for AD lesions. TCS will be used as the second-line agent for AD lesions.
|
Vehicle
n=6 Participants
Crisaborole vehicle is chosen because this contains only the inactive ingredients found in crisaborole, to serve as placebo.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the vehicle group, parents will be provided vehicle (non-medicated ointment) with unidentifiable packaging, with refills as needed. They will also have triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment provided, with refills as needed. They will be provided identical instructions to the crisaborole group with regard to usage of the vehicle and TCS.
|
Control
n=8 Participants
Aquaphor is chosen because this is a skin moisturizer which is routinely used by patients with AD.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the control group, parent(s) will be provided control (Aquaphor) in unidentifiable packaging, with refills as needed. They will also be provided triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment, with refills as needed. They will be given identical instructions to the crisaborole and vehicle groups with regard to usage of TCS.
|
|---|---|---|---|
|
Quality of Life for Participant as Assessed by Children's Dermatology Life Quality Index
|
5 score on a scale
Standard Deviation 2.83
|
3.17 score on a scale
Standard Deviation 5.38
|
4.63 score on a scale
Standard Deviation 4.93
|
SECONDARY outcome
Timeframe: Day 90Children's Dermatology Life Quality Index (ages 15 or younger). The minimum score is 0, maximum score is 30. The highest score corresponds with most severe impairment of quality of life. The lowest score corresponds with lowest impairment of quality of life.
Outcome measures
| Measure |
Crisaborole
n=4 Participants
Crisaborole is chosen because it is the newest non-steroid FDA-approved prescription topical medication for treatment of mild to moderate AD in children 2 years of age and older. The FDA-approved dosage is application of a thin layer twice daily to affected areas.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
Crisaborole: Participants will be instructed to apply crisaborole to affected areas with eczema.
In the crisaborole group, the parents will be provided with crisaborole (with unidentifiable packaging) with refills as needed. As for twice daily topical corticosteroid (TCS), triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment will be provided, with refills as needed. Aquaphor is to be applied for maintenance. Crisaborole will be used as the first-line agent for AD lesions. TCS will be used as the second-line agent for AD lesions.
|
Vehicle
n=5 Participants
Crisaborole vehicle is chosen because this contains only the inactive ingredients found in crisaborole, to serve as placebo.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the vehicle group, parents will be provided vehicle (non-medicated ointment) with unidentifiable packaging, with refills as needed. They will also have triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment provided, with refills as needed. They will be provided identical instructions to the crisaborole group with regard to usage of the vehicle and TCS.
|
Control
n=8 Participants
Aquaphor is chosen because this is a skin moisturizer which is routinely used by patients with AD.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the control group, parent(s) will be provided control (Aquaphor) in unidentifiable packaging, with refills as needed. They will also be provided triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment, with refills as needed. They will be given identical instructions to the crisaborole and vehicle groups with regard to usage of TCS.
|
|---|---|---|---|
|
Quality of Life for Participant as Assessed by Children's Dermatology Life Quality Index
|
5.75 score on a scale
Standard Deviation 2.5
|
2 score on a scale
Standard Deviation 1.58
|
3.625 score on a scale
Standard Deviation 4.37
|
SECONDARY outcome
Timeframe: Day 0Population: Some participants were lost to follow-up, data not collected.
Dermatitis Family Impact Questionnaire. Minimum score is 0, maximum score is 30. The highest score corresponds with most severe impairment of quality of life. The lowest score corresponds with lowest impairment of quality of life.
Outcome measures
| Measure |
Crisaborole
n=6 Participants
Crisaborole is chosen because it is the newest non-steroid FDA-approved prescription topical medication for treatment of mild to moderate AD in children 2 years of age and older. The FDA-approved dosage is application of a thin layer twice daily to affected areas.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
Crisaborole: Participants will be instructed to apply crisaborole to affected areas with eczema.
In the crisaborole group, the parents will be provided with crisaborole (with unidentifiable packaging) with refills as needed. As for twice daily topical corticosteroid (TCS), triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment will be provided, with refills as needed. Aquaphor is to be applied for maintenance. Crisaborole will be used as the first-line agent for AD lesions. TCS will be used as the second-line agent for AD lesions.
|
Vehicle
n=6 Participants
Crisaborole vehicle is chosen because this contains only the inactive ingredients found in crisaborole, to serve as placebo.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the vehicle group, parents will be provided vehicle (non-medicated ointment) with unidentifiable packaging, with refills as needed. They will also have triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment provided, with refills as needed. They will be provided identical instructions to the crisaborole group with regard to usage of the vehicle and TCS.
|
Control
n=9 Participants
Aquaphor is chosen because this is a skin moisturizer which is routinely used by patients with AD.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the control group, parent(s) will be provided control (Aquaphor) in unidentifiable packaging, with refills as needed. They will also be provided triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment, with refills as needed. They will be given identical instructions to the crisaborole and vehicle groups with regard to usage of TCS.
|
|---|---|---|---|
|
Quality of Life for Family as Assessed by Dermatitis Family Impact Questionnaire
|
11.17 score on a scale
Standard Deviation 5.12
|
6.67 score on a scale
Standard Deviation 6.83
|
7.89 score on a scale
Standard Deviation 6.72
|
SECONDARY outcome
Timeframe: Day 30Population: Some participants were lost to follow-up, data not collected.
Dermatitis Family Impact Questionnaire. Minimum score is 0, maximum score is 30. The highest score corresponds with most severe impairment of quality of life. The lowest score corresponds with lowest impairment of quality of life.
Outcome measures
| Measure |
Crisaborole
n=4 Participants
Crisaborole is chosen because it is the newest non-steroid FDA-approved prescription topical medication for treatment of mild to moderate AD in children 2 years of age and older. The FDA-approved dosage is application of a thin layer twice daily to affected areas.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
Crisaborole: Participants will be instructed to apply crisaborole to affected areas with eczema.
In the crisaborole group, the parents will be provided with crisaborole (with unidentifiable packaging) with refills as needed. As for twice daily topical corticosteroid (TCS), triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment will be provided, with refills as needed. Aquaphor is to be applied for maintenance. Crisaborole will be used as the first-line agent for AD lesions. TCS will be used as the second-line agent for AD lesions.
|
Vehicle
n=6 Participants
Crisaborole vehicle is chosen because this contains only the inactive ingredients found in crisaborole, to serve as placebo.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the vehicle group, parents will be provided vehicle (non-medicated ointment) with unidentifiable packaging, with refills as needed. They will also have triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment provided, with refills as needed. They will be provided identical instructions to the crisaborole group with regard to usage of the vehicle and TCS.
|
Control
n=8 Participants
Aquaphor is chosen because this is a skin moisturizer which is routinely used by patients with AD.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the control group, parent(s) will be provided control (Aquaphor) in unidentifiable packaging, with refills as needed. They will also be provided triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment, with refills as needed. They will be given identical instructions to the crisaborole and vehicle groups with regard to usage of TCS.
|
|---|---|---|---|
|
Quality of Life for Family as Assessed by Dermatitis Family Impact Questionnaire
|
7 score on a scale
Standard Deviation 4.97
|
5.5 score on a scale
Standard Deviation 9.18
|
3.125 score on a scale
Standard Deviation 2.75
|
SECONDARY outcome
Timeframe: Day 90Dermatitis Family Impact Questionnaire. Minimum score is 0, maximum score is 30. The highest score corresponds with most severe impairment of quality of life. The lowest score corresponds with lowest impairment of quality of life.
Outcome measures
| Measure |
Crisaborole
n=4 Participants
Crisaborole is chosen because it is the newest non-steroid FDA-approved prescription topical medication for treatment of mild to moderate AD in children 2 years of age and older. The FDA-approved dosage is application of a thin layer twice daily to affected areas.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
Crisaborole: Participants will be instructed to apply crisaborole to affected areas with eczema.
In the crisaborole group, the parents will be provided with crisaborole (with unidentifiable packaging) with refills as needed. As for twice daily topical corticosteroid (TCS), triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment will be provided, with refills as needed. Aquaphor is to be applied for maintenance. Crisaborole will be used as the first-line agent for AD lesions. TCS will be used as the second-line agent for AD lesions.
|
Vehicle
n=5 Participants
Crisaborole vehicle is chosen because this contains only the inactive ingredients found in crisaborole, to serve as placebo.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the vehicle group, parents will be provided vehicle (non-medicated ointment) with unidentifiable packaging, with refills as needed. They will also have triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment provided, with refills as needed. They will be provided identical instructions to the crisaborole group with regard to usage of the vehicle and TCS.
|
Control
n=8 Participants
Aquaphor is chosen because this is a skin moisturizer which is routinely used by patients with AD.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the control group, parent(s) will be provided control (Aquaphor) in unidentifiable packaging, with refills as needed. They will also be provided triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment, with refills as needed. They will be given identical instructions to the crisaborole and vehicle groups with regard to usage of TCS.
|
|---|---|---|---|
|
Quality of Life for Family as Assessed by Dermatitis Family Impact Questionnaire
|
10.25 score on a scale
Standard Deviation 11.53
|
2.6 score on a scale
Standard Deviation 3.71
|
3.125 score on a scale
Standard Deviation 3.72
|
SECONDARY outcome
Timeframe: Day 0Population: Some participants were lost to follow-up, data not collected.
Pruritus score determined using Numerical Rating Scale. Minimum score is 0. Maximum score is 10. Lowest score means no itching. Highest score corresponds to the most severe itching imaginable by patient.
Outcome measures
| Measure |
Crisaborole
n=8 Participants
Crisaborole is chosen because it is the newest non-steroid FDA-approved prescription topical medication for treatment of mild to moderate AD in children 2 years of age and older. The FDA-approved dosage is application of a thin layer twice daily to affected areas.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
Crisaborole: Participants will be instructed to apply crisaborole to affected areas with eczema.
In the crisaborole group, the parents will be provided with crisaborole (with unidentifiable packaging) with refills as needed. As for twice daily topical corticosteroid (TCS), triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment will be provided, with refills as needed. Aquaphor is to be applied for maintenance. Crisaborole will be used as the first-line agent for AD lesions. TCS will be used as the second-line agent for AD lesions.
|
Vehicle
n=7 Participants
Crisaborole vehicle is chosen because this contains only the inactive ingredients found in crisaborole, to serve as placebo.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the vehicle group, parents will be provided vehicle (non-medicated ointment) with unidentifiable packaging, with refills as needed. They will also have triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment provided, with refills as needed. They will be provided identical instructions to the crisaborole group with regard to usage of the vehicle and TCS.
|
Control
n=8 Participants
Aquaphor is chosen because this is a skin moisturizer which is routinely used by patients with AD.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the control group, parent(s) will be provided control (Aquaphor) in unidentifiable packaging, with refills as needed. They will also be provided triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment, with refills as needed. They will be given identical instructions to the crisaborole and vehicle groups with regard to usage of TCS.
|
|---|---|---|---|
|
Severity of Itching as Assessed by Pruritus Score
|
5.25 score on a scale
Standard Deviation 2.71
|
5.71 score on a scale
Standard Deviation 3.35
|
5.25 score on a scale
Standard Deviation 2.60
|
SECONDARY outcome
Timeframe: Day 30Population: Some participants were lost to follow-up, data not collected.
Pruritus score determined using Numerical Rating Scale. Minimum score is 0. Maximum score is 10. Lowest score means no itching. Highest score corresponds to the most severe itching imaginable by patient.
Outcome measures
| Measure |
Crisaborole
n=5 Participants
Crisaborole is chosen because it is the newest non-steroid FDA-approved prescription topical medication for treatment of mild to moderate AD in children 2 years of age and older. The FDA-approved dosage is application of a thin layer twice daily to affected areas.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
Crisaborole: Participants will be instructed to apply crisaborole to affected areas with eczema.
In the crisaborole group, the parents will be provided with crisaborole (with unidentifiable packaging) with refills as needed. As for twice daily topical corticosteroid (TCS), triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment will be provided, with refills as needed. Aquaphor is to be applied for maintenance. Crisaborole will be used as the first-line agent for AD lesions. TCS will be used as the second-line agent for AD lesions.
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Vehicle
n=6 Participants
Crisaborole vehicle is chosen because this contains only the inactive ingredients found in crisaborole, to serve as placebo.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the vehicle group, parents will be provided vehicle (non-medicated ointment) with unidentifiable packaging, with refills as needed. They will also have triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment provided, with refills as needed. They will be provided identical instructions to the crisaborole group with regard to usage of the vehicle and TCS.
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Control
n=8 Participants
Aquaphor is chosen because this is a skin moisturizer which is routinely used by patients with AD.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the control group, parent(s) will be provided control (Aquaphor) in unidentifiable packaging, with refills as needed. They will also be provided triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment, with refills as needed. They will be given identical instructions to the crisaborole and vehicle groups with regard to usage of TCS.
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|---|---|---|---|
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Severity of Itching as Assessed by Pruritus Score
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5.2 score on a scale
Standard Deviation 1.30
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4.17 score on a scale
Standard Deviation 2.93
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3.125 score on a scale
Standard Deviation 1.89
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SECONDARY outcome
Timeframe: Day 90Population: Some participants were lost to follow-up, data not collected.
Pruritus score determined using Numerical Rating Scale. Minimum score is 0. Maximum score is 10. Lowest score means no itching. Highest score corresponds to the most severe itching imaginable by patient.
Outcome measures
| Measure |
Crisaborole
n=3 Participants
Crisaborole is chosen because it is the newest non-steroid FDA-approved prescription topical medication for treatment of mild to moderate AD in children 2 years of age and older. The FDA-approved dosage is application of a thin layer twice daily to affected areas.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
Crisaborole: Participants will be instructed to apply crisaborole to affected areas with eczema.
In the crisaborole group, the parents will be provided with crisaborole (with unidentifiable packaging) with refills as needed. As for twice daily topical corticosteroid (TCS), triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment will be provided, with refills as needed. Aquaphor is to be applied for maintenance. Crisaborole will be used as the first-line agent for AD lesions. TCS will be used as the second-line agent for AD lesions.
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Vehicle
n=5 Participants
Crisaborole vehicle is chosen because this contains only the inactive ingredients found in crisaborole, to serve as placebo.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the vehicle group, parents will be provided vehicle (non-medicated ointment) with unidentifiable packaging, with refills as needed. They will also have triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment provided, with refills as needed. They will be provided identical instructions to the crisaborole group with regard to usage of the vehicle and TCS.
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Control
n=8 Participants
Aquaphor is chosen because this is a skin moisturizer which is routinely used by patients with AD.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the control group, parent(s) will be provided control (Aquaphor) in unidentifiable packaging, with refills as needed. They will also be provided triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment, with refills as needed. They will be given identical instructions to the crisaborole and vehicle groups with regard to usage of TCS.
|
|---|---|---|---|
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Severity of Itching as Assessed by Pruritus Score
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4 score on a scale
Standard Deviation 1.73
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2.8 score on a scale
Standard Deviation 2.17
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2.125 score on a scale
Standard Deviation 2.42
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Adverse Events
Crisaborole
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Crisaborole
n=8 participants at risk
Crisaborole is chosen because it is the newest non-steroid FDA-approved prescription topical medication for treatment of mild to moderate AD in children 2 years of age and older. The FDA-approved dosage is application of a thin layer twice daily to affected areas.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
Crisaborole: Participants will be instructed to apply crisaborole to affected areas with eczema.
In the crisaborole group, the parents will be provided with crisaborole (with unidentifiable packaging) with refills as needed. As for twice daily topical corticosteroid (TCS), triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment will be provided, with refills as needed. Aquaphor is to be applied for maintenance. Crisaborole will be used as the first-line agent for AD lesions. TCS will be used as the second-line agent for AD lesions.
|
Vehicle
n=7 participants at risk
Crisaborole vehicle is chosen because this contains only the inactive ingredients found in crisaborole, to serve as placebo.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the vehicle group, parents will be provided vehicle (non-medicated ointment) with unidentifiable packaging, with refills as needed. They will also have triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment provided, with refills as needed. They will be provided identical instructions to the crisaborole group with regard to usage of the vehicle and TCS.
|
Control
n=9 participants at risk
Aquaphor is chosen because this is a skin moisturizer which is routinely used by patients with AD.
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to affected areas.
In the control group, parent(s) will be provided control (Aquaphor) in unidentifiable packaging, with refills as needed. They will also be provided triamcinolone acetonide 0.1% ointment and hydrocortisone 2.5% ointment, with refills as needed. They will be given identical instructions to the crisaborole and vehicle groups with regard to usage of TCS.
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|---|---|---|---|
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Skin and subcutaneous tissue disorders
burning sensation after the first application of the assigned study medication.
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12.5%
1/8 • Number of events 1 • Up to 104 days
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0.00%
0/7 • Up to 104 days
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0.00%
0/9 • Up to 104 days
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60