A Study to Determine the Efficacy of ZPL-3893787 in Subjects With Atopic Dermatitis
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT02424253 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ZPL-3893787 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ziarco Pharma Ltd
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Numerical Rating Score (NRS) for Pruritus (Worst Itch) |
7.3; 7.26; 4.27; 4.6; -3.03; -2.66 | = 0.249 |
| SECONDARY Change From Baseline in Eczema Area and Severity Index (EASI) Score |
21.39; 20.44; 10.67; 15.06; -10.72; -5.38 | = 0.01 sig |
Summary
Eligibility Criteria
Inclusion Criteria
Males and females aged 18-65 years inclusive with physician documented history or diagnosis of atopic dermatitis for at least 12 months prior to screening. Chronic AD should be diagnosed by the Eichenfield revised criteria of Hanifin and Rajka (Eichenfield, 2004)
Eczema Area and Severity Index (EASI) of ≥12 and 48) that the subject could not comply with the demands of the study and/or the subject is not a suitable candidate for a placebo-controlled study
Have concurrent skin disease (e.g. acne) of such severity in the study area that it could interfere with the study evaluation or presence of skin comorbidities that may interfere with study assessments.
Have an active skin infection or any other clinically apparent infections.
Hypersensitivity to mometasone or to any other ingredients contained by the topical corticosteroid product used as rescue medication in the study.
Have received phototherapy (e.g. UVA, UVB), or systemic therapy (e.g. immunosuppressants, cytostatics) known or suspected to have an effect on AD, within 4 weeks of the start of the Run In.
Have received systemic corticosteroids ([CS] e.g. oral, intravenous, intraarticular, rectal) within 4 weeks of the start of the Run in. Subjects on a stable maintenance dose (over the preceding 3 months) of inhaled or intranasal CS may participate.
Were treated with oral antihistamines or topical calcineurin inhibitors or topical steroids within 7 days of starting Run In; intranasal antihistamines for the treatment of allergic rhinitis are acceptable.
Data sourced from ClinicalTrials.gov (NCT02424253). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.