A study to assess the safety and efficacy of ZPL389 with concomitant or intermittent use of TCS and/or TCI in atopic dermatitis patients.
Phase 2
Completed
- Conditions
- Atopic dermatitis
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
*Subjects must give a written, signed and dated informed consent
*Subjects with atopic dermatitis who have participated in and completed 16 weeks of treatment in CZPL389A2203 study.
*Willing and able to comply with scheduled visits, treatment plan, laboratory tests, diary completion and other study procedures.
Exclusion Criteria
*Inability to use TCS and/or TCI due to history of important side effects of topical medication (e.g., intolerance or hypersensitivity reactions).
*Treatment discontinued subject from CZPL389A2203 study.
*Any skin disease that would confound the diagnosis or evaluation of atopic dermatitis disease activity.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>*Frequency of AEs at Week 32 and Week 116.
- Secondary Outcome Measures
Name Time Method efficacy<br>*Investigator's global assessment response.[ Time Frame: Investigator's global assessment rating score up to Week 120 ]<br><br>*Eczema Area and Severity Index (EASI) score. [ Time Frame: EASI-50/EASI-75 response up to Week 120 ]