Atopic Dermatitis, Eczema
Conditions
Keywords
Topical steroid, Crisaborole, Topical calcineurin inhibitor
Brief summary
Atopic dermatitis, or eczema, is a chronic skin condition affecting many children. Crisaborole is a non-steroid topical medication which is FDA approved for children aged 2 and older for eczema. This research study seeks to investigate whether crisaborole reduces topical steroid use in children with atopic dermatitis.
Detailed description
Atopic dermatitis (AD) is a chronic skin disease and a common affliction among children. Twice daily topical corticosteroid (TCS) use over several weeks is recommended for active inflammatory disease. Side effects of TCS range from cutaneous atrophy to hypothalamic-pituitary-adrenal axis suppression. Steroid phobia and misunderstanding often lead to poor compliance and inadequate disease control. Topical calcineurin inhibitors (TCIs) are currently recommended as steroid-reducing agents, especially on sensitive areas such as the face and skin folds. However, TCis are associated with burning reactions and come with black box warnings. Crisaborole (Eucrisa), the newest topical prescription option for AD, is a phosphodiesterase-4 inhibitor with demonstrated efficacy in patients aged 2 and older with mild to moderate AD. Given the good tolerability and favorable safety profile, crisaborole makes for an alternative topical option to its predecessors. However, corresponding data are lacking. It would be of great interest to patients, patients' families and providers if crisaborole can be shown to reduce the amount of TCS necessary for control of AD. The investigators therefore propose a proof-of-concept study to investigate whether crisaborole can serve as an effective steroid-reducing agent.
Interventions
DRUGCrisaborole
Participants will be instructed to apply crisaborole to affected areas with eczema.
Participants will be instructed to apply hydrocortisone to affected areas with eczema on face, armpits or groin.
DRUGTriamcinolone ointment
Participants will be instructed to apply triamcinolone to affected areas on the body excluding face, armpits or groin.
DRUGAquaphor
Participants will be instructed to moisturize all over the body with Aquaphor.
Sponsors
Pfizer
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Children aged 2 or older (\<18). * Diagnosed with atopic dermatitis. * At baseline, AD is mild to moderate (score of 2 \[mild\] to 3 \[moderate\]) on the Investigator's Global Assessment scale (IGA; scores range 0-4, higher indicates greater severity).
Exclusion criteria
* Known allergy to a constituent of the studied products (crisaborole, vehicle, Aquaphor, topical steroids \[hydrocortisone 2.5% ointment and triamcinolone acetonide 0.1% ointment\]). * At baseline, AD is severe (score of 4 \[severe\] on the IGA scale). * Medical problems which interfere with completion of protocols in this study. * Pregnant or lactating females. (Females who have experienced menarche will be required to take a urine pregnancy test.) * Participant is enrolled in another research study. * Participant or participant's guardian(s) are unable to follow instructions as required in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Steroid Usage Quantity | Day 30 | Steroid usage measured in medication weight (grams) |
| Steroid Usage Frequency | Day 30 | Steroid usage measured in diary entries. Weekly average frequency of steroid use is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life for Participant as Assessed by Children's Dermatology Life Quality Index | Day 0 | 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. |
| Eczema Severity as Assessed by SCORing Atopic Dermatitis (SCORAD) Score | Day 0 | Clinical 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. |
| Severity of Itching as Assessed by Pruritus Score | Day 0 | 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. |
| Quality of Life for Family as Assessed by Dermatitis Family Impact Questionnaire | Day 0 | 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. |
| Eczema Severity Assessed by SCORAD Score | Day 30 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Crisaborole 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. | 8 |
| Vehicle 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. | 7 |
| Control 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. | 9 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | Crisaborole | Vehicle | Control | Total |
|---|---|---|---|---|
| Age, Continuous | 7.88 years STANDARD_DEVIATION 5.17 | 7.86 years STANDARD_DEVIATION 3.93 | 6.56 years STANDARD_DEVIATION 3.81 | 7.375 years STANDARD_DEVIATION 4.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 7 Participants | 2 Participants | 5 Participants | 14 Participants |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 6 Participants | 15 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 3 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 7 | 0 / 9 |
| other Total, other adverse events | 1 / 8 | 0 / 7 | 0 / 9 |
| serious Total, serious adverse events | 0 / 8 | 0 / 7 | 0 / 9 |
Outcome results
Primary
Steroid Usage Frequency
Steroid usage measured in diary entries. Weekly average frequency of steroid use is reported.
Time frame: Day 90
Population: Participants lost to follow-up in recording diaries, data not collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crisaborole | Steroid Usage Frequency | 2.74 steroids used per week | Standard Deviation 3.62 |
| Vehicle | Steroid Usage Frequency | 1.71 steroids used per week | Standard Deviation 1.8 |
| Control | Steroid Usage Frequency | 1.38 steroids used per week | Standard Deviation 1.11 |
Primary
Steroid Usage Frequency
Steroid usage measured in diary entries. Weekly average frequency of steroid use is reported.
Time frame: Day 30
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crisaborole | Steroid Usage Frequency | 1.81 steroids used per week | Standard Deviation 1.41 |
| Vehicle | Steroid Usage Frequency | 1.27 steroids used per week | Standard Deviation 1.21 |
| Control | Steroid Usage Frequency | 1.85 steroids used per week | Standard Deviation 1.09 |
Primary
Steroid Usage Quantity
Steroid usage measured in medication weight (grams)
Time frame: Day 90
Population: 3 withdrew, 9 lost to followup
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crisaborole | Steroid Usage Quantity | 37.82 grams | Standard Deviation 27.49 |
| Vehicle | Steroid Usage Quantity | 16.15 grams | Standard Deviation 18.79 |
| Control | Steroid Usage Quantity | 5.43 grams | Standard Deviation 11.13 |
Primary
Steroid Usage Quantity
Steroid usage measured in medication weight (grams)
Time frame: Day 30
Population: 3 withdrew, 7 lost to followup
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crisaborole | Steroid Usage Quantity | 7.27 grams | Standard Deviation 10 |
| Vehicle | Steroid Usage Quantity | 10.78 grams | Standard Deviation 20.77 |
| Control | Steroid Usage Quantity | 8.22 grams | Standard Deviation 10.39 |
Secondary
Eczema Severity as Assessed by SCORing Atopic Dermatitis (SCORAD) Score
Clinical 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.
Time frame: Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crisaborole | Eczema Severity as Assessed by SCORing Atopic Dermatitis (SCORAD) Score | 29.15 score on a scale | Standard Deviation 10.79 |
| Vehicle | Eczema Severity as Assessed by SCORing Atopic Dermatitis (SCORAD) Score | 28.75 score on a scale | Standard Deviation 9.68 |
| Control | Eczema Severity as Assessed by SCORing Atopic Dermatitis (SCORAD) Score | 29.04 score on a scale | Standard Deviation 14.43 |
Secondary
Eczema Severity Assessed by SCORAD Score
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.
Time frame: Day 90
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crisaborole | Eczema Severity Assessed by SCORAD Score | 25.78 score on a scale | Standard Deviation 7.9 |
| Vehicle | Eczema Severity Assessed by SCORAD Score | 17.20 score on a scale | Standard Deviation 8.74 |
| Control | Eczema Severity Assessed by SCORAD Score | 18.99 score on a scale | Standard Deviation 10.66 |
Secondary
Eczema Severity Assessed by SCORAD Score
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.
Time frame: Day 30
Population: There were some lost-to-follow up after Day 0.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crisaborole | Eczema Severity Assessed by SCORAD Score | 26.88 score on a scale | Standard Deviation 9.64 |
| Vehicle | Eczema Severity Assessed by SCORAD Score | 25.40 score on a scale | Standard Deviation 17.49 |
| Control | Eczema Severity Assessed by SCORAD Score | 22.66 score on a scale | Standard Deviation 8.21 |
Secondary
Quality of Life for Family as Assessed by Dermatitis Family Impact Questionnaire
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.
Time frame: Day 90
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crisaborole | Quality of Life for Family as Assessed by Dermatitis Family Impact Questionnaire | 10.25 score on a scale | Standard Deviation 11.53 |
| Vehicle | Quality of Life for Family as Assessed by Dermatitis Family Impact Questionnaire | 2.6 score on a scale | Standard Deviation 3.71 |
| Control | Quality of Life for Family as Assessed by Dermatitis Family Impact Questionnaire | 3.125 score on a scale | Standard Deviation 3.72 |
Secondary
Quality of Life for Family as Assessed by Dermatitis Family Impact Questionnaire
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.
Time frame: Day 0
Population: Some participants were lost to follow-up, data not collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crisaborole | Quality of Life for Family as Assessed by Dermatitis Family Impact Questionnaire | 11.17 score on a scale | Standard Deviation 5.12 |
| Vehicle | Quality of Life for Family as Assessed by Dermatitis Family Impact Questionnaire | 6.67 score on a scale | Standard Deviation 6.83 |
| Control | Quality of Life for Family as Assessed by Dermatitis Family Impact Questionnaire | 7.89 score on a scale | Standard Deviation 6.72 |
Secondary
Quality of Life for Family as Assessed by Dermatitis Family Impact Questionnaire
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.
Time frame: Day 30
Population: Some participants were lost to follow-up, data not collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crisaborole | Quality of Life for Family as Assessed by Dermatitis Family Impact Questionnaire | 7 score on a scale | Standard Deviation 4.97 |
| Vehicle | Quality of Life for Family as Assessed by Dermatitis Family Impact Questionnaire | 5.5 score on a scale | Standard Deviation 9.18 |
| Control | Quality of Life for Family as Assessed by Dermatitis Family Impact Questionnaire | 3.125 score on a scale | Standard Deviation 2.75 |
Secondary
Quality of Life for Participant as Assessed by Children's Dermatology Life Quality Index
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.
Time frame: Day 30
Population: Some participants were lost to follow-up, data not collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crisaborole | Quality of Life for Participant as Assessed by Children's Dermatology Life Quality Index | 5 score on a scale | Standard Deviation 2.83 |
| Vehicle | Quality of Life for Participant as Assessed by Children's Dermatology Life Quality Index | 3.17 score on a scale | Standard Deviation 5.38 |
| Control | Quality of Life for Participant as Assessed by Children's Dermatology Life Quality Index | 4.63 score on a scale | Standard Deviation 4.93 |
Secondary
Quality of Life for Participant as Assessed by Children's Dermatology Life Quality Index
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.
Time frame: Day 90
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crisaborole | Quality of Life for Participant as Assessed by Children's Dermatology Life Quality Index | 5.75 score on a scale | Standard Deviation 2.5 |
| Vehicle | Quality of Life for Participant as Assessed by Children's Dermatology Life Quality Index | 2 score on a scale | Standard Deviation 1.58 |
| Control | Quality of Life for Participant as Assessed by Children's Dermatology Life Quality Index | 3.625 score on a scale | Standard Deviation 4.37 |
Secondary
Quality of Life for Participant as Assessed by Children's Dermatology Life Quality Index
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.
Time frame: Day 0
Population: Some participants were lost to follow-up, data not collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crisaborole | Quality of Life for Participant as Assessed by Children's Dermatology Life Quality Index | 10.67 score on a scale | Standard Deviation 5.65 |
| Vehicle | Quality of Life for Participant as Assessed by Children's Dermatology Life Quality Index | 4.67 score on a scale | Standard Deviation 4.5 |
| Control | Quality of Life for Participant as Assessed by Children's Dermatology Life Quality Index | 8.89 score on a scale | Standard Deviation 5.99 |
Secondary
Severity of Itching as Assessed by Pruritus Score
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.
Time frame: Day 90
Population: Some participants were lost to follow-up, data not collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crisaborole | Severity of Itching as Assessed by Pruritus Score | 4 score on a scale | Standard Deviation 1.73 |
| Vehicle | Severity of Itching as Assessed by Pruritus Score | 2.8 score on a scale | Standard Deviation 2.17 |
| Control | Severity of Itching as Assessed by Pruritus Score | 2.125 score on a scale | Standard Deviation 2.42 |
Secondary
Severity of Itching as Assessed by Pruritus Score
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.
Time frame: Day 30
Population: Some participants were lost to follow-up, data not collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crisaborole | Severity of Itching as Assessed by Pruritus Score | 5.2 score on a scale | Standard Deviation 1.3 |
| Vehicle | Severity of Itching as Assessed by Pruritus Score | 4.17 score on a scale | Standard Deviation 2.93 |
| Control | Severity of Itching as Assessed by Pruritus Score | 3.125 score on a scale | Standard Deviation 1.89 |
Secondary
Severity of Itching as Assessed by Pruritus Score
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.
Time frame: Day 0
Population: Some participants were lost to follow-up, data not collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crisaborole | Severity of Itching as Assessed by Pruritus Score | 5.25 score on a scale | Standard Deviation 2.71 |
| Vehicle | Severity of Itching as Assessed by Pruritus Score | 5.71 score on a scale | Standard Deviation 3.35 |
| Control | Severity of Itching as Assessed by Pruritus Score | 5.25 score on a scale | Standard Deviation 2.6 |