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
Among 13 studies testing roflumilast in Dermatitis, Atopic — 4 open to participants now, 4 under way, 1 of them phase 3. Roflumilast · Dermatitis, Atopic.
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.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's planned enrollment of 40 is below the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →4 of the 13 studies testing roflumilast in Dermatitis, Atopic are open now, in 2 countries. Each count lists the studies.
Roflumilast: first FDA approval 2011 (DALIRESP), first EMA approval 2010. What it is approved for, and how studies give it, is on its page →
Of the 193 Dermatitis, Atopic studies recruiting now, 83 (43%) set no upper age limit and 94 (49%) stop at 75 or younger; 93 take children under 18; 51 take healthy volunteers.
This study: 12 Years and older · all sexes · no healthy volunteers.
The full table on the hub →13 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 3 started in 2026.
Median enrollment 136 across the 13 interventional studies. Of the 9 that completed or were terminated, 6 (67%) have results posted.
11 of 13 have an industry lead sponsor. The 6 most frequent:
Integrative Skin Science and Research is the lead sponsor of 35 studies on the registry; 12 are open to participants now.
Integrative Skin Science and Research has 3 studies filed under Dermatitis, Atopic — fewer than ten, so there is no comparison to draw.
1 of the studies testing roflumilast in Dermatitis, Atopic that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07560618Integrative Skin Science and ResearchObtaining Descriptive Classifications of Pruritus and Assessing Change in Pruritus Over Time in Atopic Dermatitis Patients Using Topical Roflumilast Cream. | 2027-08 |
Among the 13 studies testing roflumilast in Dermatitis, Atopic, from their registry updates:
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.
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.
Exclusion Criteria:
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.
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.
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.
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.
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).
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.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Roflumilast Cream 0.15%
topically applied to the affected areas once daily
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.
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
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
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
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
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
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
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
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
Plan to share: No
No publications or documents are linked to this record.
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Studies of the drug tested here: Roflumilast
Integrative Skin Science and Research →