Phase 4
N=24
Steroid-reducing Effects of Crisaborole
Atopic Dermatitis · Eczema
Bottom Line
View on ClinicalTrials.gov: NCT03832010 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Steroid Usage Quantity — 7.27; 10.78; 8.22 grams
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Crisaborole (Drug); Hydrocortisone Ointment (Drug); Triamcinolone ointment (Drug); Aquaphor (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Steroid Usage Quantity |
37.82; 16.15; 5.43 | — |
| PRIMARY Steroid Usage Quantity |
37.82; 16.15; 5.43 | — |
| PRIMARY Steroid Usage Frequency |
2.74; 1.71; 1.38 | — |
| PRIMARY Steroid Usage Frequency |
2.74; 1.71; 1.38 | — |
| SECONDARY Eczema Severity as Assessed by SCORing Atopic Dermatitis (SCORAD) Score |
29.15; 28.75; 29.04 | — |
| SECONDARY Eczema Severity Assessed by SCORAD Score |
25.78; 17.20; 18.99 | — |
| SECONDARY Eczema Severity Assessed by SCORAD Score |
25.78; 17.20; 18.99 | — |
| SECONDARY Quality of Life for Participant as Assessed by Children's Dermatology Life Quality Index |
5.75; 2; 3.625 | — |
| SECONDARY Quality of Life for Participant as Assessed by Children's Dermatology Life Quality Index |
5.75; 2; 3.625 | — |
| SECONDARY Quality of Life for Participant as Assessed by Children's Dermatology Life Quality Index |
5.75; 2; 3.625 | — |
| SECONDARY Quality of Life for Family as Assessed by Dermatitis Family Impact Questionnaire |
10.25; 2.6; 3.125 | — |
| SECONDARY Quality of Life for Family as Assessed by Dermatitis Family Impact Questionnaire |
10.25; 2.6; 3.125 | — |
| SECONDARY Quality of Life for Family as Assessed by Dermatitis Family Impact Questionnaire |
10.25; 2.6; 3.125 | — |
| SECONDARY Severity of Itching as Assessed by Pruritus Score |
4; 2.8; 2.125 | — |
| SECONDARY Severity of Itching as Assessed by Pruritus Score |
4; 2.8; 2.125 | — |
| SECONDARY Severity of Itching as Assessed by Pruritus Score |
4; 2.8; 2.125 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03832010). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.