Obtaining Descriptive Classifications of Pruritus and Assessing Change in Pruritus Over Time in Atopic Dermatitis Patients Using Topical Roflumilast Cream.

Official title

A Phase 4, Open Label Study to Assess Descriptive Classification of Pruritus Over Time With Roflumilast 0.15% Cream in Patients With Atopic Dermatitis

Overview

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.

Interventions

• Drug Roflumilast Cream 0.15%
  topically applied to the affected areas once daily

Primary outcome measures

• Number of descriptors (besides itch) used to describe skin sensations associated with AD [Time frame: From enrollment to end of treatment at 4 weeks.]

Secondary outcome measures (6)

• Change from baseline in modified Itch Numeric Rating Scale (mItch-NRS) on first day of application. [Time frame: Day of baseline visit]
• Change from baseline in Worst Itch Numeric Rating Scale (WI-NRS) at 4 weeks [Time frame: From enrollment to end of treatment at 4 weeks]
• Change from baseline in Dermatology Life Quality Index (DLQI) [Time frame: From enrollment to end of treatment at 4 weeks]
• Change from baseline in Validated Investigator Global Assessment of Atopic Dermatitis (vIGA-AD) [Time frame: From enrollment to the end of treatment at 4 weeks]
• Change from baseline in Eczema Area and Severity Index (EASI) [Time frame: From enrollment to the end of treatment at 4 weeks]
• Change from baseline in Body Surface Area (BSA) [Time frame: From enrollment to the end of treatment at 4 weeks]

Eligibility criteria

Inclusion criteria

• Male or female subjects aged 12 years or older
• Participants and/or legal guardians are legally competent to sign and give informed consent.
• Clinically confirmed diagnosis of active mild to moderate AD according to Hanifin and Rajka criteria (1980).
• 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
• At least 3 months of chronic pruritus related to AD before the screening visit.
• EASI Score ≥5 at Baseline. EASI is evaluated for the entire body except the scalp, palms, and soles.
• 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.
• Has AD involvement of ≥3% BSA (excluding the scalp, palms, soles) at Baseline.
• Participants must have access to a device and be willing to download the ExpiWell app and able to complete the associated questionnaires once daily at approximately the same time each day throughout participation in the study.
• Prior to the first application of study drug, participant has a baseline WI-NRS (24-hour recall period) and mItch-NRS score ≥ 4.0.
• Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at Screening and Baseline/Day 1. In addition, sexually active FOCBP must agree to use at least one form of a highly effective or barrier method of contraception throughout the trial. The use of abstinence as a contraceptive measure is acceptable if this is a consistent part of a lifestyle choice and an acceptable backup method has been identified if the subject becomes sexually active.
• Females of non-childbearing potential should be post-menopausal with spontaneous amenorrhea for at least 12 months (post-menopausal status should be confirmed with FSH testing) or have undergone surgical sterilization (permanent sterilization methods include hysterectomy, bilateral oophorectomy, hysteroscopic sterilization, bilateral tubal ligation or bilateral salpingectomy).
• In good health as judged by the Investigator, based on medical history, targeted physical examination, and vital signs. Subjects and parent(s)/legal guardian(s) are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.

Exclusion criteria

• 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.
• Subjects who cannot discontinue medications and treatments prior to the Baseline visit and during the study according to Excluded Medications and Treatments.
• 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.
• 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.
• 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).
• 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.
• Participants have tattoos, scratches, open sores, excessive hair, or skin damage that, in the opinion of the investigator, may interfere with study evaluations.
• Subjects with known genetic dermatological conditions that overlap with AD, such as Netherton syndrome.
• Known allergies to roflumilast or to the excipients in Roflumilast cream (petrolatum, isopropyl palmitate, methylparaben, propylparaben, diethylene glycol monoethyl ether, hexylene glycol, cetylstearyl alcohol, dicetyl phosphase and ceteth-10 phosphate).
• Participant has a clearly defined etiology for pruritus other than AD, including but not limited to urticaria, psoriasis, or other nonatopic dermatologic conditions; hepatic or renal disease; psychogenic pruritus; drug reaction; uncontrolled hyperthyroidism; and infection.
• Subjects who have received oral roflumilast (Daxas®, Daliresp®) within 4 weeks prior to Baseline/ Day 1.
• History of severe depression, suicidal ideation or behavior at Baseline/Screening indicative of suicidal ideation or behavior, whether lifetime or recent/current.
• Subjects currently undergoing allergy testing (eg, food allergy testing or skin prick testing), patch testing, food challenges, or allergy desensitization, or plan to do so during the study.
• Subjects with any serious medical condition (eg, uncontrolled hypo- or hyper-thyroidism) or clinically significant laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
• Previous treatment with Roflumilast cream or foam (any potency) or current Roflumilast use for any indication at the baseline visit that would be expected to continue during the trial.
• Subjects with a history of major surgery within 4 weeks prior to Baseline/Day 1 or subjects who have major surgery planned during the study.
• Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
• Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects living in the same house.
• Subjects with known or suspected severe renal insufficiency or moderate to severe liver impairment (Child-Pugh B or C) as determined by the clinical investigator based upon subject's medical history and physical exam.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Integrative Skin Science and Research — Sacramento

Identifiers

NCT: NCT07560618 · ARQ-MA-000251

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗