ASPIRE: PROs & Caregiver Burden in Children With Atopic Dermatitis

NCT03645057 | Completed Phase 3 Results FDA Drug

• 1 other identifier: RSRB73062
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  baseline to 12 weeks

Secondary Outcomes (5)

• Mean Change in Children's Dermatology Life Quality Index

  baseline to 12 weeks

• Mean Change in Children's Sleep Habits Questionnaire

  Baseline to 12 Weeks

• Mean Change in PROMIS Anxiety-children (Adaptive Test)

  baseline to 12 weeks

• Mean Change in PROMIS Depressive Symptoms-Pediatric (Adaptive Test)

  baseline to 12 weeks

• Mean Change in Children's Eczema Area & Severity Index (EASI)

  baseline to 12 weeks

Other Outcomes (2)

• Mean Change in Caregiver Burden Inventory

  baseline to 12 weeks

• Mean Change in Family Dermatology Life Quality Index

  baseline to 12 weeks

Study Arms (2)

Crisaborole

EXPERIMENTAL

The topical treatment will be applied to all affected areas twice daily for 12 weeks.

Drug: Crisaborole

Tacrolimus 0.03%

ACTIVE COMPARATOR

The topical treatment will be applied to all affected areas twice daily for 12 weeks.

Drug: Tacrolimus 0.03% Ointment

Interventions

Crisaborole DRUG

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.

Also known as: Eucrisa

Crisaborole

Tacrolimus 0.03% Ointment DRUG

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.

Also known as: Protopic

Tacrolimus 0.03%

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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.
• e) 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Dermatology

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

crisaborole; Tacrolimus; Ointments

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Julie Ryan
• Organization: University of Rochester

Julie_Ryan@URMC.Rochester.edu

(585) 276-3862

Study Officials

• Julie R Wolf, PhD, MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Dermatology & Radiation Oncology

Model Details: 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.

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 24, 2018
• Study Start: February 20, 2019
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: October 31, 2022
• Results First Posted: October 31, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)