Atopic Dermatitis Clinical Trial
Official title:
Single Center, Pilot Study to Evaluate the Effectiveness and Safety of Dupilumab in Combination With Narrowband UVB (nUVB) Phototherapy in the Treatment of Moderate-to-Severe Atopic Dermatitis
24 weeks open-label study with dupilumab and narrowband UVB phototherapy three times weekly for 12 weeks followed by 12 weeks of dupilumab monotherapy.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | December 15, 2024 |
| Est. primary completion date | December 1, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Male or female adult = 18 years of age; - Diagnosis of moderate to severe atopic dermatitis as defined at baseline by: - EASI score of 16 or greater, - IGA score of 3 or greater - BSA of 10% or greater, Exclusion Criteria: - Subjects with previous exposure to dupilumab. - Known or suspected hypersensitivity to dupilumab or any of its excipients. - History of photosensitivity. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Eczema Treatment Center of New Jersey | East Windsor | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Psoriasis Treatment Center of Central New Jersey | Regeneron Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Investigators Global Assessment Score of score of 0 or 1 | Proportion of subjects achieving an IGA score of 0 or 1 with at least a 2 grade improvement at week 12 | 12 weeks |
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|---|---|---|---|
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