Improvement In Scratch Behavior And Sleep In Patients With Atopic Dermatitis (NCT05200403) | Clinical Trial Compass
TerminatedPhase 4
Improvement In Scratch Behavior And Sleep In Patients With Atopic Dermatitis
Stopped: Funding was stoppped by grantor.
United States72 participantsStarted 2022-07-26
Plain-language 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.
Who can participate
Age range3 Months – 75 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
What they're measuring
1
Number of Children's Nighttime Scratching Episodes
Timeframe: 2 weeks
2
Duration of Children's Nighttime Scratching Episodes
✕. 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).
✕. 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).
✕. Participants who are or have been on crisaborole treatment regimen in the past.
✕. 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.