Atopic DermatitisPhase 3NCT03645057
ASPIRE: PROs & Caregiver Burden in Children With Atopic Dermatitis
A Phase 3 study testing Crisaborole and Tacrolimus 0.03% Ointment in people with Atopic Dermatitis, run by University of Rochester at 1 site in United States.
Trial summary
This is an open-label, randomized, cross-sectional study to monitor the effects of crisaborole and tacrolimus 0.03% on patient-reported outcomes and caregiver burden in children (ages 2 to 15 years, inclusive) with ≤ moderate atopic dermatitis over a 12 week period of time. Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Crisaborole and Tacrolimus 0.03% Ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2019to 1 Aug 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric Subjects:
- Male and female subjects of inclusive ages of 2 to 15 years (inclusive) at screening visit.
- Diagnosis of ≤moderate atopic dermatitis or eczema (ISGA 2 or 3 and ≥3% BSA, excluding scalp).
- If subject is taking or prescribed antihistamines, subject must be on stable dose of antihistamines.
- If subject is taking or prescribed topical steroids, subject must be on stable dose of topical steroids.
- If taking a systemic anti-inflammatory medication for atopic dermatitis or other condition, subject must be on stable dose of the systemic anti-inflammatory medication for six weeks prior to enrollment.
Show all 13Show fewer
- If subject is currently taking or prescribed tacrolimus or crisaborole, or other steroid-sparring medication, subject must agree to two week (i.e., 14 days) washout period prior to randomization and Baseline Assessment for study.
- Caregiver (i.e., adult parent or guardian) must agree to participate in the study with the patient.
- Subject must be able to read and speak English. f) Subject ages ≥8 years, is able to give assent.
- Caregiver Subjects:
- Subject must be at least 18 years old and the parent or guardian of the eligible pediatric subject.
- Subject must be able to read and speak English.
- Subject must be able to give informed consent.
Who cannot join
- Pediatric subjects <2 years old or >15 years old are not eligible for participation in this study.
- Pediatric subjects with a diagnosis with another skin disease (i.e., not atopic dermatitis or eczema) are excluded to prevent confounding of results.
- Pediatric subjects currently on systemic anti-inflammatory therapy for atopic dermatitis or other indication are excluded.
- Caregiver subject <18 years old are excluded.
- Pediatric subject participation without caregiver participation is not allowed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Dermatology
Rochester, New York, 14642
About this study
Official title: ASPIRE: DETERIMINING THE IMPACT OF CRISABOROLE (Eucrisa) AND TACROLIMUS 0.03% ON PATIENT-REPORTED OUTCOMES AND CAREGIVER BURDEN IN CHILDREN WITH ATOPIC DERMATITIS
This is an open-label, randomized, cross-sectional study to monitor the effects of crisaborole and tacrolimus 0.03% on patient-reported outcomes and caregiver burden in children (ages 2 to 15 years, inclusive) with ≤ moderate atopic dermatitis over a 12 week period of time. The goal of this study is to detect changes in PROs and caregiver burden during treatment for atopic dermatitis of moderate or less severity. The study design will allow us to correlate PROs and caregiver burden with treatment response and disease improvement in children.
Read the detailed description
Atopic dermatitis (AD) is a common, chronic skin disease affecting 20% of children and 10% of adults worldwide (1-3). Children with AD often develop the disease within the first five years of life, which is a critical time for physical and psychosocial development (4). AD impacts an individual's physical, mental, and social health. Anxiety, itch, sleep disturbance, and depression have been associated with low quality of life scores. Childhood AD also affects the emotional, financial, physical, and social well-being of parents or caregivers (4). Individuals caring for a child with AD report sleep deprivation, poor social support, and stress about parenting (1, 4). Utilizing patient-reported outcomes (PROs) in clinic can provide meaningful data to monitor disease activity and response to different interventions, with the ultimate goal to improve quality of life for the patient and their family members or caregivers. Additionally, PROs can help us better understand the burden of AD. It is still unclear which PROs are most relevant for atopic dermatitis. This study will evaluate the utility of several PROs to monitor response to two different topical ointments, crisaborole (Eucrisa™) and tacrolimus 0.03%, to better understand the impact of these two non-steroidal topical treatments on overall health of children with AD of moderate or less severity and their caregivers.
- Conditions
- Atopic Dermatitis
- Being tested
- Crisaborole, Tacrolimus 0.03% Ointment
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrisaboroleDrug
Also called Eucrisa
This topical ointment is FDA-approved to treat atopic dermatitis of moderate or less severity in children. Subjects will apply the topical ointment to all affected areas twice daily for 12 weeks.
Tacrolimus 0.03% OintmentDrug
Also called Protopic
This topical ointment is FDA-approved to treat atopic dermatitis in children. Subjects will apply the topical ointment to all affected areas twice daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Crisaborole | Experimental | The topical treatment will be applied to all affected areas twice daily for 12 weeks. Receives: Drug: Crisaborole |
| Tacrolimus 0.03% | Active comparator | The topical treatment will be applied to all affected areas twice daily for 12 weeks. Receives: Drug: Tacrolimus 0.03% Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Children's PROMIS Pediatric Itch Short-Form
This is a patient-reported outcome measure for Itch in pediatric patients that consists of 8 fixed items items, spanning four domains (general, activity, mood/sleep, and scratching behavior). Each item is scored on using 1 = No Itch, 2 = Mild, 3 = Moderate, 4 = Severe, and 5 = Very Severe. The range of the scale is 1 to 5 with higher numbers indicating worse outcome. A total score, representing overall itch-related quality of life, is scored by taking the average (i.e., divide by 8) of the sum of all 8 items. Therefore, total itch scores range between 1 and 5, with higher scores indicating worse impact of itch on quality of life. The measure was completed electronically on an iPad using REDCap.
Measured: baseline to 12 weeks
Mean Change in PROMIS Pain Interference-Children (Adaptive Test)
This is a patient reported outcome measure for pain interference in pediatric patients. This is a computer adaptive test consisting of 4-12 questions related to how pain interferes with daily activities. The number of questions a patient answers depends on how he or she answers each question. The overall domain score ranges from 0 to100 with a score of 50 representing the average score for the general population. Higher scores indicate greater pain interference. A score above 55 is considered "clinically significant" for each domain. A score change of 5 or more is considered a clinically important change in domain severity. This measure was completed electronically on an iPad using REDCap.
Measured: baseline to 12 weeks
Secondary outcomes (5)
Mean Change in Children's Dermatology Life Quality Index
This patient-reported outcome measure will be completed using an iPad. The 10-item questionnaire designed for use in parents of children (i.e., ages 4-17) to obtain information on children's quality of life. Each question relates to a component of quality of life: Symptoms/Feelings (items 1-2); Leisure (items 4-6); School (item 7); Relationships (items 3-8); Sleep (item 9), and Treatment (item 10). Children answer each question using a 4-point scale: Not at all = 0, A Little = 1, Quite A Lot = 2, Very Much = 3. The scores from each item are summed to create a severity burden score (i.e., minimum score = 0; maximum score = 30). Higher the scores, the greater burden on quality of life. The scores represent degree of severity burden on quality of life: No effect = 0-1; Small effect = 2-6; Moderate effect = 7-12; Very large effect = 13-18; and Extremely large effect = 19-30.
Measured: baseline to 12 weeks
Mean Change in Children's Sleep Habits Questionnaire
This patient-reported outcome measure was completed by the caregiver using an iPad. This is a validated 22 item questionnaire consisting of 4 subscales: Bedtime, Sleep Behavior, Waking During the Night, and Morning Wake Up. The patient/parent will answer each item choosing from: "Always" if something occurs every night; "Usually" if it occurs 5 or 6 times a week; "Sometimes" if it occurs 2 to 4 times a week; "Rarely" if it occurs once a week; and "Never" if it occurs less than once a week. Each question is scored on a 3-point scale as 1 = Usually and Always (5-7 times/week); 2 = Sometimes" (2-4 times/week); or 3 = Rarely and Never (0-1 time/week). The scores are combined from each subscale to generate a Total Sleep Disturbance Score, which can range from 22 (minimum) to 66 (maximum). The higher the score, the greater the sleep disturbance. A Total Sleep Disturbances score over 28 represent clinically significant sleep disturbance.
Measured: Baseline to 12 Weeks
Mean Change in PROMIS Anxiety-children (Adaptive Test)
This patient-reported outcome measure will be completed by the child patient electronically on an iPad using computer adaptive test (CAT). The CAT consists of 4-12 questions on feelings related to anxiety. The number of questions a patient answers depends on how he or she answers each question. The domain score is a t-score ranging from 0 to 100 with a score of 50 representing the average score for the general population. Higher scores indicate greater anxiety. A score above 55 is considered "clinically significant" for each domain. A score change of 5 or more is considered a clinically important change in domain severity. This PRO was completed electronically on an iPad using REDCap.
Measured: baseline to 12 weeks
Mean Change in PROMIS Depressive Symptoms-Pediatric (Adaptive Test)
This patient-reported outcome measure s will be completed by the child patient electronically on an iPad using computer adaptive test (CAT). The CAT consists of 4-12 questions on feelings related to depressive symptoms. The number of questions a patient answers depends on how he or she answers each question. The domain score is a t-score ranging from 0 to 100 with a score of 50 representing the average score for the general population. Higher scores indicate greater depressive symptoms. A score above 55 is considered "clinically significant" for each domain. A score change of 5 or more is considered a clinically important change in domain severity. This PRO was completed electronically on an iPad using REDCap.
Measured: baseline to 12 weeks
Mean Change in Children's Eczema Area & Severity Index (EASI)
Clinician rated the severity of atopic dermatitis using the EASI. The EASI is a tool used to measure the extent (area) and severity of AD. It does not include a grade for dryness or scaling and includes only inflamed areas. The area score is a 7-point scale representing the percentage of skin affected by AD for each body region. The severity score is recorded for each of the four regions of the body and is the sum of the intensity scores for four signs. The four signs include redness, thickness, scratching, and lichenification. The intensity scores are performed using a 4-pont scale. The final EASI score is the sum of the total scores for each region. Add up the total scores for each region to determine the final EASI score. The minimum EASI score is 0 and the maximum EASI score is 72. Higher scores represent worse AD severity.
Measured: baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start20 Feb 2019
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an open-label, randomized, cross-sectional study to monitor the effects of crisaborole and tacrolimus 0.03% on patient-reported outcomes and caregiver burden in children (ages 2 to 15 years, inclusive) with ≤ moderate atopic dermatitis over a 12 week period of time.
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Ryan Wolf, University of Rochester
- Investigators
- Julie R Wolf, PhD, MPH, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645057
- Sponsor's protocol ID
- RSRB73062
- Status last verified
- Oct 2022
- First submitted
- 22 Aug 2018
- Last updated
- 31 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASPIRE: DETERIMINING THE IMPACT OF CRISABOROLE (Eucrisa) AND TACROLIMUS 0.03% ON PATIENT-REPORTED OUTCOMES AND CAREGIVER BURDEN IN CHILDREN WITH ATOPIC DERMATITIS
- ClinicalTrials.gov ID
- NCT03645057
- Acronym / sponsor ID
- RSRB73062
- Conditions
- Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Posted 31 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, randomized, cross-sectional study to monitor the effects of crisaborole and tacrolimus 0.03% on patient-reported outcomes and caregiver burden in children (ages 2 to 15 years, inclusive) with ≤ moderate atopic dermatitis over a 12 week period of time. The goal of this study is to detect changes in PROs and caregiver burden during treatment for atopic dermatitis of moderate or less severity. The study design will allow us to correlate PROs and caregiver burden with treatment response and disease improvement in children.
Detailed description
Atopic dermatitis (AD) is a common, chronic skin disease affecting 20% of children and 10% of adults worldwide (1-3). Children with AD often develop the disease within the first five years of life, which is a critical time for physical and psychosocial development (4). AD impacts an individual's physical, mental, and social health. Anxiety, itch, sleep disturbance, and depression have been associated with low quality of life scores. Childhood AD also affects the emotional, financial, physical, and social well-being of parents or caregivers (4). Individuals caring for a child with AD report sleep deprivation, poor social support, and stress about parenting (1, 4). Utilizing patient-reported outcomes (PROs) in clinic can provide meaningful data to monitor disease activity and response to different interventions, with the ultimate goal to improve quality of life for the patient and their family members or caregivers. Additionally, PROs can help us better understand the burden of AD. It is still unclear which PROs are most relevant for atopic dermatitis. This study will evaluate the utility of several PROs to monitor response to two different topical ointments, crisaborole (Eucrisa™) and tacrolimus 0.03%, to better understand the impact of these two non-steroidal topical treatments on overall health of children with AD of moderate or less severity and their caregivers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an open-label, randomized, cross-sectional study to monitor the effects of crisaborole and tacrolimus 0.03% on patient-reported outcomes and caregiver burden in children (ages 2 to 15 years, inclusive) with ≤ moderate atopic dermatitis over a 12 week period of time.
| Arm | Type | Receives |
|---|---|---|
| Crisaborole | Experimental | Drug: CrisaboroleThe topical treatment will be applied to all affected areas twice daily for 12 weeks. |
| Tacrolimus 0.03% | Active comparator | Drug: Tacrolimus 0.03% OintmentThe topical treatment will be applied to all affected areas twice daily for 12 weeks. |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Male and female subjects of inclusive ages of 2 to 15 years (inclusive) at screening visit.
- Diagnosis of ≤moderate atopic dermatitis or eczema (ISGA 2 or 3 and ≥3% BSA, excluding scalp).
- If subject is taking or prescribed antihistamines, subject must be on stable dose of antihistamines.
- If subject is taking or prescribed topical steroids, subject must be on stable dose of topical steroids.
- If taking a systemic anti-inflammatory medication for atopic dermatitis or other condition, subject must be on stable dose of the systemic anti-inflammatory medication for six weeks prior to enrollment.
Key exclusion criteria (5 listed)
- Pediatric subjects <2 years old or >15 years old are not eligible for participation in this study.
- Pediatric subjects with a diagnosis with another skin disease (i.e., not atopic dermatitis or eczema) are excluded to prevent confounding of results.
- Pediatric subjects currently on systemic anti-inflammatory therapy for atopic dermatitis or other indication are excluded.
- Caregiver subject <18 years old are excluded.
- Pediatric subject participation without caregiver participation is not allowed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CrisaboroleAlso: EucrisaThis topical ointment is FDA-approved to treat atopic dermatitis of moderate or less severity in children. Subjects will apply the topical ointment to all affected areas twice daily for 12 weeks. | Drug | Crisaborole |
| Tacrolimus 0.03% OintmentAlso: ProtopicThis topical ointment is FDA-approved to treat atopic dermatitis in children. Subjects will apply the topical ointment to all affected areas twice daily for 12 weeks. | Drug | Tacrolimus 0.03% |
Primary outcome
Mean Change in Children's PROMIS Pediatric Itch Short-Form
Time frame: baseline to 12 weeks
This is a patient-reported outcome measure for Itch in pediatric patients that consists of 8 fixed items items, spanning four domains (general, activity, mood/sleep, and scratching behavior). Each item is scored on using 1 = No Itch, 2 = Mild, 3 = Moderate, 4 = Severe, and 5 = Very Severe. The range of the scale is 1 to 5 with higher numbers indicating worse outcome. A total score, representing overall itch-related quality of life, is scored by taking the average (i.e., divide by 8) of the sum of all 8 items. Therefore, total itch scores range between 1 and 5, with higher scores indicating worse impact of itch on quality of life. The measure was completed electronically on an iPad using REDCap.
Mean Change in PROMIS Pain Interference-Children (Adaptive Test)
Time frame: baseline to 12 weeks
This is a patient reported outcome measure for pain interference in pediatric patients. This is a computer adaptive test consisting of 4-12 questions related to how pain interferes with daily activities. The number of questions a patient answers depends on how he or she answers each question. The overall domain score ranges from 0 to100 with a score of 50 representing the average score for the general population. Higher scores indicate greater pain interference. A score above 55 is considered "clinically significant" for each domain. A score change of 5 or more is considered a clinically important change in domain severity. This measure was completed electronically on an iPad using REDCap.
5 secondary outcomes
Mean Change in Children's Dermatology Life Quality Index
Time frame: baseline to 12 weeks
Mean Change in Children's Sleep Habits Questionnaire
Time frame: Baseline to 12 Weeks
Mean Change in PROMIS Anxiety-children (Adaptive Test)
Time frame: baseline to 12 weeks
Mean Change in PROMIS Depressive Symptoms-Pediatric (Adaptive Test)
Time frame: baseline to 12 weeks
Mean Change in Children's Eczema Area & Severity Index (EASI)
Time frame: baseline to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie R Wolf, PhD, MPH principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Crisaborole and Tacrolimus 0.03% Ointment in people with Atopic Dermatitis, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Children's PROMIS Pediatric Itch Short-Form (time frame: baseline to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022.