ITCHPhase 4NCT07560618
Obtaining Descriptive Classifications of Pruritus and Assessing Change in Pruritus Over Time in Atopic Dermatitis Patients Using Topical Roflumilast Cream.
A Phase 4 study testing Roflumilast Cream 0.15% in people with ITCH and Atopic Dermatitis, run by Integrative Skin Science and Research at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- ITCH, Atopic Dermatitis
- What is being tested?
- Roflumilast Cream 0.15%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2026to Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Integrative Skin Science and Research
Sacramento, California, 95815
Nasima Afzal, 9165241216, nasima@integrativeskinresearch.com
Raja Sivamani, MD
About this study
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
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.
- Conditions
- ITCH, Atopic Dermatitis
- Being tested
- Roflumilast Cream 0.15%
- Keywords
- Eczema, Itch, Pruritus, Atopic Dermatitis, Topical
- Medical subject headings
- Dermatitis, Atopic, Eczema, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roflumilast Cream 0.15%Drug
topically applied to the affected areas once daily
| Study group | Role | What they receive |
|---|---|---|
| Roflumilast Group | Experimental | Not described Receives: Drug: Roflumilast Cream 0.15% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of descriptors (besides itch) used to describe skin sensations associated with AD
Participants will download and install the ExpiWell app. Descriptive classification of itch will be captured in the app. The number of descriptions selected by the participant will be tabulated to assess if there is more than just a description of itch for their skin sensation.
Measured: From enrollment to end of treatment at 4 weeks.
Secondary outcomes (6)
Change from baseline in modified Itch Numeric Rating Scale (mItch-NRS) on first day of application.
Change from baseline in mItch-NRS at 5, 10, 15, 20, 25, 30, 45, 60, 90, and 120 minutes, and 4, 6, and 8 hours
Measured: Day of baseline visit
Change from baseline in Worst Itch Numeric Rating Scale (WI-NRS) at 4 weeks
Change in the Worst Itch Numeric Rating Scale (WI-NRS) response from baseline to week 4
Measured: From enrollment to end of treatment at 4 weeks
Change from baseline in Dermatology Life Quality Index (DLQI)
Change from baseline in DLQI at week 2 and week 4
Measured: From enrollment to end of treatment at 4 weeks
Change from baseline in Validated Investigator Global Assessment of Atopic Dermatitis (vIGA-AD)
Change from baseline in vIGA-AD at week 2 and week 4
Measured: From enrollment to the end of treatment at 4 weeks
Change from baseline in Eczema Area and Severity Index (EASI)
Change from baseline in EASI at week 2 and week 4
Measured: From enrollment to the end of treatment at 4 weeks
Change from baseline in Body Surface Area (BSA)
Change from baseline in BSA at week 2 and week 4
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start21 Jul 2026
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ITCHStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrative Skin Science and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Arcutis Biotherapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- Raja K Sivamani, MD MS AP, Principal investigator, Integrative Skin Science and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560618
- Sponsor's protocol ID
- ARQ-MA-000251
- Status last verified
- Aug 2026
- First submitted
- 23 Apr 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07560618
- Acronym / sponsor ID
- ARQ-MA-000251
- Conditions
- ITCH, Atopic Dermatitis
- Keywords
- Eczema, Itch, Pruritus, Atopic Dermatitis, Topical
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Integrative Skin Science and ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Arcutis Biotherapeutics, Inc.
- Study start
- 21 Jul 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Roflumilast Group | Experimental | Drug: Roflumilast Cream 0.15% |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (19 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roflumilast Cream 0.15%topically applied to the affected areas once daily | Drug | Roflumilast Group |
Primary outcome
Number of descriptors (besides itch) used to describe skin sensations associated with AD
Time frame: From enrollment to end of treatment at 4 weeks.
Participants will download and install the ExpiWell app. Descriptive classification of itch will be captured in the app. The number of descriptions selected by the participant will be tabulated to assess if there is more than just a description of itch for their skin sensation.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals
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Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
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Topographical Distribution of Itch and Pain Receptors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raja K Sivamani, MD MS AP principal investigator
Integrative Skin Science and Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Roflumilast Cream 0.15% in people with ITCH and Atopic Dermatitis, run by Integrative Skin Science and Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nasima Afzal Chief Operating Officer (916-775-5080, nasima@integrativeskinresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of descriptors (besides itch) used to describe skin sensations associated with AD (time frame: From enrollment to end of treatment at 4 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.