Atopic dermatitis
Conditions
Interventions
None listed
Sponsors
Kyushu University Department of Dermatology, Graduate School of Medical SciencesDepartment of Dermatology, Graduate School of Medical Sciences, Kyushu University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Chronic atopic dermatitis that has been present for >=3 years at enrollment. (2) Mild-to-severe patients with EASI score of >=16, IGA score of >=3, and BSA >=10% at enrollment (excluded if inflammation is limited to the head and neck region). (3) No treatment history of dupilumab. (4) Patients in whom topical steroid treatment provides insufficient inhibition or is medically inadvisable. (5) Patients aged >=18 years and <=70 years at enrollment. (6) Patients who are able to completely understand the study plan and to provide signed informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients treated with oral immunosuppressive drugs, oral steroid, or phototherapy within 4 weeks before dupilumab administration. (2) Female patients who are breastfeeding, pregnant, or have the possibility of being pregnant. (3) Any other patients who are regarded as unsuitable for this study by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Association between "baseline levels of 18 biomarkers" and "% change from baseline of EASI at 16w of dupilumab treatment." | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Association between "baseline levels of potential proteomic markers" and "% change from baseline of EASI at 16w," (2) Association between "baseline levels of 18 biomarkers" and "% change from baseline of POEM at 16w," (3) Association between "baseline levels of potential proteomic markers" and "% change from baseline of POEM at 16w," (4) Association between "baseline levels of 18 biomarkers" and "% change from baseline of Pruritus-NRS at 16w," (5) Association between "baseline levels of potential proteomic markers" and "% change from baseline of Pruritus-NRS at 16w," (6) Association between "baseline levels of 18 biomarkers" and "% change from baseline of Skin Comfort-NRS at 16w," (7) Association between "baseline levels of potential proteomic markers" and "% change from baseline of Skin Comfort-NRS at 16w," (8) Association between "baseline levels of 18 biomarkers" and "% change from baseline of Treatment Satisfaction-NRS at 16w," (9) Association between "baseline levels of potential proteomic markers" and "% change from baseline of Treatment Satisfaction-NRS at 16w." | — |
Countries
Japan
Contacts
Public ContactTakeshi Nakahara
Kyushu University Division of Skin Surface Sensing
Outcome results
None listed