Obtaining Descriptive Classifications of Pruritus and Assessing Change in Pruritus Over Time in Aā¦ (NCT07560618) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Obtaining Descriptive Classifications of Pruritus and Assessing Change in Pruritus Over Time in Atopic Dermatitis Patients Using Topical Roflumilast Cream.
United States40 participantsStarted 2026-04
Plain-language summary
This study is being done to obtain descriptive classifications of pruritus using a patient directed survey system and assess change in pruritus over time in patients with Atopic Dermatitis over 4 weeks with use of topical Roflumilast cream 0.15% QD.
Who can participate
Age range12 Years
SexALL
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Inclusion criteria
ā. Male or female subjects aged 12 years or older
ā. Participants and/or legal guardians are legally competent to sign and give informed consent.
ā. Clinically confirmed diagnosis of active mild to moderate AD according to Hanifin and Rajka criteria (1980).
ā. History of AD for at least 6 months as determined by the Investigator using information from the subject's medical chart, from the subject's physician, or through subject/caregiver interview. Stable disease for the past 4 weeks with no significant flares in atopic dermatitis before screening
ā. At least 3 months of chronic pruritus related to AD before the screening visit.
ā. EASI Score ā„5 at Baseline. EASI is evaluated for the entire body except the scalp, palms, and soles.
ā. vIGA-AD score of 'Mild' (2') or 'Moderate' (3') at Baseline. The vIGA-AD is evaluated for the entire body except the scalp, palms, and soles.
ā. Has AD involvement of ā„3% BSA (excluding the scalp, palms, soles) at Baseline.
Exclusion criteria
ā. Subjects with any medical condition or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.
ā. Subjects who cannot discontinue medications and treatments prior to the Baseline visit and during the study according to Excluded Medications and Treatments.
What they're measuring
1
Number of descriptors (besides itch) used to describe skin sensations associated with AD
Timeframe: From enrollment to end of treatment at 4 weeks.
. Participant had significant flares or unstable course in AD (i.e., condition worsened significantly or required significant change in medications, as per medical judgment) in the previous 4 weeks before screening or any consistent requirement for high potency topical steroids to manage AD signs or symptoms.
ā. Participant has significant active systemic or localized infection, like clinically infected AD, or has used antibiotics (systemic or topical), antifungal or antiviral agents within 2 weeks prior to the run-in period.
ā. Participant with a history or presence of a condition that, in the opinion of the investigator, would interfere with the study assessments (e.g., generalized erythroderma, Netherton syndrome, psoriasis, or any skin condition other than AD that may risk inducing a pruritus flare/worsening).
ā. Subjects who are unwilling to refrain from prolonged sun exposure and from using a tanning bed or other artificial light emitting devices (LEDs) for 4 weeks prior to Baseline/Day 1 and during the study.
ā. Participants have tattoos, scratches, open sores, excessive hair, or skin damage that, in the opinion of the investigator, may interfere with study evaluations.
ā. Subjects with known genetic dermatological conditions that overlap with AD, such as Netherton syndrome.