Improvement In Scratch Behavior And Sleep In Patients With Atopic Dermatitis

NCT ID: NCT05200403

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-26
• Study Completion Date: 2024-02-15

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.

Detailed Description

Approximately 270 children participants, age 3 months to ≤ 11 years, and their primary caregiver participants, for a total of 540 participants (270 pairs) will be randomized in 1:1 ratio to either Crisaborole (2% BID) or vehicle treatment and will be followed for 2 weeks. Participants will be asked to apply a thin even-layer of Crisaborole (2%) or vehicle twice daily (BID), excluding mouth, eyes, and vagina, per label, to all locations with active lesions (except for hands/fingers or within 1 to 2 fingers of the mouth to avoid inadvertent ingestion of ointment) and record location and time of application on the daily dosing form (provided by study staff, and as identified on the Dosing Record Sheet, breastfeeding women will be instructed to use the provided gloves when applying Crisaborole/vehicle). The study will be comprised of an initial screening/baseline visit for children participants who have an existing diagnosis of symptomatic AD, screened and enrolled in the study along with their primary caregivers after signing an informed consent (for parents/guardians and assent when appropriate).

Primary Objective:

1. Evaluate the effects of Crisaborole on itch and night-time scratch (as measured by accelerometry/actigraphy and Observer Reported Itch Assessment (3 months to ≤ 11 years old)) in children with mild to moderate AD between the ages of 3 months to ≤ 11 years old.

Secondary Objectives:

1. Evaluate the effects of Crisaborole on sleep in children ages 3 months to ≤ 11 years with mild to moderate AD.

2. Evaluate sleep in primary caregivers.

3. Evaluate the QoL measures in response to Crisaborole treatment (children 3 months to ≤ 11 years).

4. Evaluate QoL measures in response to the child's treatment, to the parents/caregivers/families.

5. Evaluate the effect of crisaborole treatment on AD signs, symptoms and severity in children ages 3 months to ≤ 11 years with mild to moderate AD.

The study will consist of a screening/baseline (in-laboratory) visit on Day -7 (V01), an in-laboratory visit Day 1 (V02), an in-laboratory visit on Day 2 (V03) for tape-striping, and Day 8 (V04) for a clinical assessment of the severity of the AD and a final in-laboratory visit on Day 15 (V05) for an assessment of the AD, tape-stripping, completion of ObsROs and return devices. Throughout the study, the participants and caregivers will wear accelerometry devices continuously (optional for those who have active AD on location of device placement, with a minimum of at least one wrist device needed for enrollment; devices may be removed for short periods of time for such things as the purposes of bathing, etc.). Enrolled participants will be randomly assigned to each arm of the study. Participants may come in for an unscheduled visit as needed (i.e., to replace compound, etc.). All in-person study activities, including informed consent and pregnancy testing, will be completed at the Laboratory for Human Neurobiology, 650 Albany St X140, Boston, MA, 02118. All activities performed in the laboratory are accomplished in private rooms. Primary caregivers will be provided with ample time and a privacy curtain to change into a gown during assessment for exclusion of Atopic Dermatitis, and primary caregivers will accompany children during all activities to ensure participant privacy. All at-home study activities will be completed in the participants' home.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Crisaborole 2%

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

Group Type: EXPERIMENTAL

Crisaborole 2%

Intervention Type: DRUG

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

Accelerometry device for children

Intervention Type: 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.

Accelerometry device for adult caregivers

Intervention Type: 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.

Vehicle Arm

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

Group Type: ACTIVE_COMPARATOR

Vehicle treatment

Intervention Type: 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).

Accelerometry device for children

Intervention Type: 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.

Accelerometry device for adult caregivers

Intervention Type: 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.

Interventions

Crisaborole 2%

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

Intervention Type: DRUG

Vehicle treatment

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).

Intervention Type: DRUG

Accelerometry device for children

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.

Intervention Type: DEVICE

Accelerometry device for adult caregivers

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.

Intervention Type: DEVICE

Other Intervention Names

EUCRISA; Nonmedicated ointment

Eligibility Criteria

Inclusion Criteria

1. Male or female participants aged between ≥3 months of age and ≤ 11 years of age at Day -7.

2. Written informed consent from participant/parent(s)/guardian(s).

3. Native English speakers or demonstrated fluency in English (as age appropriate).

4. 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).

5. Have a clinical diagnosis of AD according to the criteria of Hanifin and Rajka.

6. Have AD involvement ≥ 5% Treatable % Body Surface Area (BSA) excluding the scalp and less than 40% BSA.

7. Have an Investigator's Static Global Assessment (ISGA) score of Mild (2) or Moderate (3) at the baseline visit.

8. Have an Eczema Area and Severity Index (EASI) total score of ≥3 at Day -7.

9. 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.

10. 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).

11. 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.

1. Primary caregiver of the enrolled child participant, between ≥18 years of age and ≤75 years of age.

2. Able to understand and cooperate with study procedures and give informed consent.

3. Native English speakers or demonstrated fluency in English

4. Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.

5. ISGA score of 0 or 1 of AD at the screening visit, and no reported diagnosis of Atopic Dermatitis

6. WRAT-4 Word Reading Subtest equivalent to 8th grade reading level or greater.

Exclusion Criteria

1. 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.

2. Participants who are on systemic corticosteroids or immunosuppressive agents within 28 days of Day -7 (V01).

3. 3. 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).

4. Participants who are or have been on crisaborole treatment regimen in the past.

5. Allergy to polyurethane resin (strap/wristband component), skin nickel allergy, silicone, and/or adhesives.

6. Has documented non-AD related insomnia, sleep apnea or other sleep-related disorders (e.g., narcolepsy, restless legs syndrome, circadian rhythm disorder).

7. Participant has a known lack of efficacy to crisaborole.

8. Participant scores <20 on the Childhood Asthma Control Test (ages 4-≤ 11) indicating poorly controlled asthma.

9. If participant has a history of angioedema or anaphylaxis.

10. Has a significant active systemic or localized infection, including actively infected.

11. Has any planned surgical or medical procedure that would overlap with study participation.

12. Participants with cardiac pacemakers, electronic pumps or any other implanted medical devices.

13. Participants who are unable to wear at least one wrist device (one accelerometry device on at least one wrist).

1. 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.)

2. 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.

3. Current shift worker or travel across more than two time zones in the past 2 weeks, and/or during the study period.

4. Has any planned surgical or medical procedure that would overlap with study participation.

5. Participants who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are Boston University (BU)/Boston Medical Center (BMC) employees directly involved in the conduct of the study.

6. Allergy to polyurethane resin (strap/wristband component), skin nickel allergy, silicone, and/or adhesives.

7. A female who is pregnant.

8. The primary caregiver or share the same domicile of another child who has previously been or is currently enrolled in the study.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin C Thomas, PhD

Role: PRINCIPAL_INVESTIGATOR

BU School of Medicine, Anatomy and Neurobiology

Locations

BU CAMed Laboratory for Human Neurobiology

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

H-42240

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H-42240

Identifier Type: -

Identifier Source: org_study_id