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| Name | Class |
|---|---|
| Arcutis Biotherapeutics, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Roflumilast Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roflumilast Cream 0.15% | Drug | topically applied to the affected areas once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to end of treatment at 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day of baseline visit |
| Change from baseline in Worst Itch Numeric Rating Scale (WI-NRS) at 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Treatment Satisfaction Questionnaire (TSQ) outcomes | Change from baseline in TSQ outcomes at week 2 and week 4 | From enrollment to the end of treatment at 4 weeks |
| Impact assessment question outcome trends |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nasima Afzal Chief Operating Officer | Contact | 916-775-5080 | nasima@integrativeskinresearch.com |
| Name | Affiliation | Role |
|---|---|---|
| Raja K Sivamani, MD MS AP | Integrative Skin Science and Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integrative Skin Science and Research | Sacramento | California | 95815 | United States |
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Change in the Worst Itch Numeric Rating Scale (WI-NRS) response from baseline to week 4 |
| 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 | 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 | 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 | 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 | From enrollment to the end of treatment at 4 weeks |
Assessing Impact assessment question outcomes at baseline and week 4
| From enrollment to the end of treatment at 4 weeks |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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