A study to assess the safety and efficacy of ZPL389 with concomitant or intermittent use of TCS and/or TCI in atopic dermatitis patients

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 123

Inclusion Criteria

1. Signed informed consent must be obtained before any assessment is performed.
2. Female and male subjects with atopic dermatitis who have participated in and completed 16 weeks of treatment in CZPL389A2203 study.
3. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, diary
completion and other study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 215
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1. Inability to use TCS and/or TCI concomitantly or intermittently due to history of
important side effects of topical medication (e.g., intolerance to treatment, hypersensitivity reactions, significant skin atrophy, systemic effects), as assessed by the investigator or subject’s treating physician.
2. Subjects who met any study and/or treatment discontinuation criteria during the
CZPL389A2203 study (Section 9.1).
3. Any active skin disease that, in the opinion of the investigator, would confound the diagnosis or evaluation of AD disease activity (e.g., Netherton Syndrome, Cutaneous T-Cell
Lymphoma, extensive contact dermatitis, chronic actinic dermatitis)
4. Subjects taking medications prohibited by the protocol (see Section 6.2.2)
5. Pregnant or nursing (lactating) women
6. Women of child-bearing potential (WOCBP), defined as all women physiologically
capable of becoming pregnant, unless they use required methods of contraception during
dosing and for 4 weeks after stopping of investigational medication.
7. Sexually active males unless they use a condom during intercourse while taking drug and for 4 weeks after stopping investigational medication and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent
delivery of the drug via seminal fluid.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

A study to assess the safety and efficacy of ZPL389 with concomitant or intermittent use of TCS and/or TCI in atopic dermatitis patients

Recruitment & Eligibility

Study & Design

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