ITCH study: Roflumilast Cream
Official title Obtaining Descriptive Classifications of Pruritus and Assessing Change in Pruritus Over Time in Atopic Dermatitis Patients Using Topical Roflumilast Cream.
ClinicalTrials.gov ID: NCT07560618
What this study is testing
What is Roflumilast Cream 0.15%?
An investigational topical cream being studied as a potential treatment for itch in atopic dermatitis. It is designed to inhibit phosphodiesterase‑4 (PDE4), which may reduce inflammatory signaling in the skin.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether using roflumilast cream changes itch over time.
- Who it's for
- You may be able to join if you have atopic dermatitis and itchy skin.
- What's involved
- You will put a small amount of roflumilast cream on the itchy area once each day for four weeks. You will also fill out a short survey about your itch.
- Time commitment
- The study lasts about four weeks with daily cream use and periodic surveys.
- Phase 4: studies an already-approved treatment
- Time commitment: about 4 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Male or female people 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...
- At least 3 months of chronic pruritus related to AD before the screening visit.
You likely can't join if
- people with any medical condition or physical examination abnormality that would prevent study participation or place the subject at significant...
- people who cannot discontinue medications and treatments prior to the Baseline visit and during the study according to Excluded Medications and...
- Participant had significant flares or unstable course in AD (i.e., condition worsened significantly or required significant change in medications, as...
- Participant has significant active systemic or localized infection, like clinically infected AD, or has used antibiotics (systemic or topical)...
- Participant with a history or presence of a condition that, in the opinion of the investigator, would interfere with the study assessments (e.g...
- people who are unwilling to refrain from prolonged sun exposure and from using a tanning bed or other artificial light emitting devices (LEDs) for 4...
See the full eligibility criteria
Who can join
- Male or female people 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.
- 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...
- 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.
- 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...
- In good health as judged by the Investigator, based on medical history, targeted physical examination, and vital signs.
What rules you out
- people 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.
- people 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...
- 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...
- people 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.
- people 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...
- 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
- people 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.
- people 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.
- people 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...
- 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.
- people with a history of major surgery within 4 weeks prior to Baseline/Day 1 or people who have major surgery planned during the study.
- people with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
- people who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled people living in the same house.
- people 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Sacramento, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Sacramento, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.