Improvement In Scratch Behavior And Sleep In Patients With Atopic Dermatitis

NCT05200403 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: H-42240
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This single blind study is to primarily evaluate wearable devices and Observer Reported Itch Assessment in children to assess reduction of itch and night-time scratch in response to Crisaborole treatment vs. vehicle treatment (active control comparator without crisaborole) in children with atopic dermatitis (AD). Participants, age 3 months to 11 years with symptomatic mild to moderate AD, along with their primary caregivers will be recruited. The goal of this study is to more fully evaluate the rapid onset of night-time itch and scratch relief, as well as improvements in sleep following treatment with Crisaborole in comparison to vehicle treatment in children with AD. the study will also assess the quality of life (QoL) and sleep within the associated caregivers.

Conditions

Atopic Dermatitis

Keywords

Night-time itch; Night-time scratch; Crisaborole; Children 3 months to ≤ 11 years; Accelerometry; Actigraphy; Quality of life; Vehicle

Outcome Measures

Primary Outcomes (3)

• Number of Children's Nighttime Scratching Episodes

  The number of nighttime scratching episodes will be recorded on by accelerometry.

  2 weeks

• Duration of Children's Nighttime Scratching Episodes

  The duration of nighttime scratching episodes will be recorded on by accelerometry.

  2 weeks

• Scratch Assessment by Adult Caregiver

  Adult caregivers will fill out the Observer Reported Itch Assessment (ORIA) which is a single question assessment to assess the severity of the child participant's itch. The minimum score of "0" indicates "no itch" and the maximum score of "10" indicates "worst itch imaginable."

  2 weeks

Study Arms (2)

Crisaborole 2%

EXPERIMENTAL

Adult caregivers of children participants will be asked to apply a thin even-layer of Crisaborole (2%) twice daily for 2 weeks.

Drug: Crisaborole 2%; Device: Accelerometry device for children; Device: Accelerometry device for adult caregivers

Vehicle Arm

ACTIVE COMPARATOR

Adult caregivers of children participants will be asked to apply a thin even-layer of vehicle treatment twice daily for 2 weeks.

Drug: Vehicle treatment; Device: Accelerometry device for children; Device: Accelerometry device for adult caregivers

Interventions

Crisaborole 2% DRUG

The adult caregiver will apply a thin layer of Crisaborole 2% topically on their child participant twice a day for 2 weeks.

Also known as: EUCRISA

Crisaborole 2%

Vehicle treatment DRUG

The adult caregiver will apply a thin layer of the vehicle treatment topically on their child participant twice a day for 2 weeks. The vehicle treatment is made of excipients of crisaborole ointment (non-medicated ointment).

Also known as: Nonmedicated ointment

Vehicle Arm

Accelerometry device for children DEVICE

Children participants will wear two wrist worn (or wrist worn AND ankle worn for 3 months up to \<2 years) accelerometry devices. Devices will be optional for child participants who have active AD on location of device placement, with a minimum of at least one wrist device needed for enrollment.

Crisaborole 2%; Vehicle Arm

Accelerometry device for adult caregivers DEVICE

Adult caregiver participants will wear two accelerometry devices (one on each wrist) and complete daily assessments related to scratching, sleeping habits, pain, AD severity, quality of life, and device comfort questionnaires.

Crisaborole 2%; Vehicle Arm

Eligibility Criteria

• Age: 3 Months - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants aged between ≥3 months of age and ≤ 11 years of age at Day -7.
• Written informed consent from participant/parent(s)/guardian(s).
• Native English speakers or demonstrated fluency in English (as age appropriate).
• Participants and parent(s)/guardian(s) are willing and able to comply with study instructions, study visits, procedures, and device placement (devices will be optional for those who have active AD on location of device placement, with a minimum of at least one wrist device needed for enrollment).
• Have a clinical diagnosis of AD according to the criteria of Hanifin and Rajka.
• Have AD involvement ≥ 5% Treatable % Body Surface Area (BSA) excluding the scalp and less than 40% BSA.
• Have an Investigator's Static Global Assessment (ISGA) score of Mild (2) or Moderate (3) at the baseline visit.
• Have an Eczema Area and Severity Index (EASI) total score of ≥3 at Day -7.
• Have a minimum Observer Reported Itch Assessment score of 2 at Day -7 (ages 3 months - ≤ 5 years only) or a minimum Patient Reported Itch Severity Scale score of 2 (ages 6 years - ≤ 11 years old) at Day -7.
• Participant/parent(s)/guardian(s) agrees to refrain from applying diaper rash creams, lotions, ointments, powders, etc. where AD lesions are present, unless AD lesions are present where crisaborole cannot be applied (face within 1 or 2 fingers away from the mouth and hands/fingers).
• Participants must agree to refrain from applying crisaborole/vehicle to AD lesions on the fingers or hands or within 1 or 2 fingers away from the the mouth to prevent inadvertent ingestion of ointment.
• Primary caregiver of the enrolled child participant, between ≥18 years of age and ≤75 years of age.
• Able to understand and cooperate with study procedures and give informed consent.
• Native English speakers or demonstrated fluency in English
• Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.

You may not qualify if:

• Has any clinically significant medical disorder, condition, disease (including active or potentially recurrent non-AD dermatological conditions and known genetic dermatological conditions that overlap with AD, such as Netherton syndrome) or clinically significant finding at baseline that precludes participant's participation in study activities.
• Participants who are on systemic corticosteroids or immunosuppressive agents within 28 days of Day -7 (V01).
• \. Participants who are on topical AD treatment such as low-to-high-potency corticosteroids, TCIs, antihistamines, antibiotics, sodium hypochlorite-based products, antibacterial soaps, bleach baths, diaper rash creams, lotions, ointments, powders, light therapy, and use of bland emollients on or overlapping with treatable AD-involved areas within 7 days of Day -7 (V01), unless AD lesions are present where crisaborole cannot be applied (face within 1 or 2 fingers away from the of mouth and hands/fingers).
• Participants who are or have been on crisaborole treatment regimen in the past.
• Allergy to polyurethane resin (strap/wristband component), skin nickel allergy, silicone, and/or adhesives.
• Has documented non-AD related insomnia, sleep apnea or other sleep-related disorders (e.g., narcolepsy, restless legs syndrome, circadian rhythm disorder).
• Participant has a known lack of efficacy to crisaborole.
• Participant scores \<20 on the Childhood Asthma Control Test (ages 4-≤ 11) indicating poorly controlled asthma.
• If participant has a history of angioedema or anaphylaxis.
• Has a significant active systemic or localized infection, including actively infected.
• Has any planned surgical or medical procedure that would overlap with study participation.
• Participants with cardiac pacemakers, electronic pumps or any other implanted medical devices.
• Participants who are unable to wear at least one wrist device (one accelerometry device on at least one wrist).
• Has any clinically significant medical disorder, condition, disease or clinically significant finding at screening that precludes Caregivers participation in study activities (e.g., sleep apnea, narcolepsy, etc.)
• History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1drink=5ounces (150mL) wine, 12 ounces (360mL) of beer, or 1.5 ounces (45mL) of hard liquor) within 6 months of screening as disclosed by participant during evaluation.

Sponsors & Collaborators

• Boston University: lead
• Pfizer: collaborator

Study Sites (1)

BU CAMed Laboratory for Human Neurobiology

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

crisaborole

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

Limitations and Caveats

Funding was stopped by grantor.

Results Point of Contact

• Title: Kevin Thomas, PhD, MBA
• Organization: Boston University School of Medicine

kipthoma@bu.edu

617-358-9787

Study Officials

• Kevin C Thomas, PhD

  BU School of Medicine, Anatomy and Neurobiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: January 20, 2022
• Study Start: July 26, 2022
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: March 14, 2025
• Results First Posted: March 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)