ClinicalTrials.gg
RecruitingNCT07560618Updated Aug 13, 2026

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

A Phase 4 interventional study of Roflumilast Cream 0.15% in ITCH and Atopic Dermatitis, sponsored by Integrative Skin Science and Research. Recruiting at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Integrative Skin Science and Research · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
12 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 13 studies testing roflumilast in Dermatitis, Atopic — 4 open to participants now, 4 under way, 1 of them phase 3. Roflumilast · Dermatitis, Atopic.

Planned enrollment
10th of 13
40 · median 136
Started
2026
with 2 others
Phase 4
2 of 13
2 open now
Registered
12th of 13
by date
Lead sponsor
1 of 13
Integrative Skin Science and Research

Among the 13 studies testing roflumilast in Dermatitis, Atopic, this one is the 10th largest by planned enrollment, is one of 3 that started in 2026, is one of 2 in phase 4, and was the 12th registered.

By phase

13 studies; the count open now beside each. This study's row is marked.

Phase 36 · 1 open
Phase 24 · 1 open
Phase 4this study2 · 2 open
Phase 11 · 0 open

By the year they started

First in 2013; this study’s year is marked. 3 started in 2026.

Size and results

Median enrollment 136 across the 13 interventional studies. Of the 9 that completed or were terminated, 6 (67%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 13 studies testing roflumilast in Dermatitis, Atopic, or all of them as a file.
02

Study 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.

03

Conditions studied

  • ITCH
  • Atopic Dermatitis

Keywords

  • Eczema
  • Itch
  • Pruritus
  • Atopic Dermatitis
  • Topical
04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female subjects aged 12 years or older
  2. Participants and/or legal guardians are legally competent to sign and give .
  3. Clinically confirmed diagnosis of active mild to moderate AD according to Hanifin and Rajka criteria (1980).
  4. 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
  5. At least 3 months of chronic pruritus related to AD before the screening visit.
  6. EASI Score ≥5 at Baseline. EASI is evaluated for the entire body except the scalp, palms, and soles.
  7. 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.
  8. Has AD involvement of ≥3% BSA (excluding the scalp, palms, soles) at Baseline.
  9. 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.
  10. Prior to the first application of study drug, participant has a baseline WI-NRS (24-hour recall period) and mItch-NRS score ≥ 4.0.
  11. Females of (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 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.
  12. Females of non-childbearing potential should be 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).
  13. 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

Exclusion Criteria:

  1. 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.
  2. Subjects who cannot discontinue medications and treatments prior to the Baseline visit and during the study according to Excluded Medications and Treatments.
  3. 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 to manage AD signs or symptoms.
  4. 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.
  5. 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).
  6. 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.
  7. Participants have tattoos, scratches, open sores, excessive hair, or skin damage that, in the opinion of the investigator, may interfere with study evaluations.
  8. Subjects with known genetic dermatological conditions that overlap with AD, such as Netherton syndrome.
  9. Known allergies to roflumilast or to the in Roflumilast cream (petrolatum, isopropyl palmitate, methylparaben, propylparaben, diethylene glycol monoethyl ether, hexylene glycol, cetylstearyl alcohol, dicetyl phosphase and ceteth-10 phosphate).
  10. 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.
  11. Subjects who have received oral roflumilast (Daxas®, Daliresp®) within 4 weeks prior to Baseline/ Day 1.
  12. History of severe depression, suicidal ideation or behavior at Baseline/Screening indicative of suicidal ideation or behavior, whether lifetime or recent/current.
  13. 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.
  14. Subjects with any serious medical condition (eg, uncontrolled hypo- or hyper-thyroidism) or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
  15. 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.
  16. 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.
  17. Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
  18. 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.
  19. Subjects with known or suspected severe renal insufficiency or moderate to severe liver impairment ( B or C) as determined by the clinical investigator based upon subject's medical history and physical exam.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Roflumilast Group

    Drug: Roflumilast Cream 0.15%

Interventions

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From enrollment to end of treatment at 4 weeks.

Secondary outcomes

  1. 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

    Time frame: Day of baseline visit

  2. 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

    Time frame: From enrollment to end of treatment at 4 weeks

  3. Change from baseline in Dermatology Life Quality Index (DLQI)

    Change from baseline in DLQI at week 2 and week 4

    Time frame: From enrollment to end of treatment at 4 weeks

  4. 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

    Time frame: From enrollment to the end of treatment at 4 weeks

  5. Change from baseline in Eczema Area and Severity Index (EASI)

    Change from baseline in EASI at week 2 and week 4

    Time frame: From enrollment to the end of treatment at 4 weeks

  6. Change from baseline in Body Surface Area (BSA)

    Change from baseline in BSA at week 2 and week 4

    Time frame: From enrollment to the end of treatment at 4 weeks

Other outcomes

  1. Change from baseline in Treatment Satisfaction Questionnaire (TSQ) outcomes

    Change from baseline in TSQ outcomes at week 2 and week 4

    Time frame: From enrollment to the end of treatment at 4 weeks

  2. Impact assessment question outcome trends

    Assessing Impact assessment question outcomes at baseline and week 4

    Time frame: From enrollment to the end of treatment at 4 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07560618
Responsible party
Sponsor
First posted
May 1, 2026
Start date
Jul 21, 2026
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Aug 13, 2026

Study contacts

Nasima Afzal Chief Operating Officer
Contact
nasima@integrativeskinresearch.com
916-775-5080
Raja K Sivamani, MD MS AP
principal investigator · Integrative Skin Science and Research

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Roflumilast

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