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E6005 in Pediatric Atopic Dermatitis

NCT02094235Phase 2

Key facts

Status: Completed
Start: Jan 2014
Primary completion: Dec 2014
Countries: 1
Sponsor: Organon & Co.
Modality: Small Molecules

Drugs: lotamilast
Conditions: atopic dermatitis (AD)

Overview

Phase 2, randomised, double-blind trial of lotamilast in atopic dermatitis (AD) (3 arms), sponsored by Organon & Co. Primary endpoints: Pharmacokinetics of E6005 up to 21 Days and Number of participants with adverse events up to 21 Days. Started Jan 2014; status: completed.

Design

3 arms

Study design: RandomizedDouble-blind

E6005 0.2%
E6005 0.2% ointment twice daily
E6005 0.05%
E6005 0.05% ointment twice daily
Placebo
Placebo ointment twice daily

Who it enrols

Pediatric patients (2-15 years) with mild to moderate atopic dermatitis, having evaluable skin lesions (25-100 cm2), and using moisturizers. Excludes patients with active infections, serious allergies, or recent use of biologics/other AD treatments.

Endpoints

Primary

Pharmacokinetics of E6005Up to 21 Days
Number of participants with adverse eventsUp to 21 Days

Secondary

Change from Baseline in severity score of targeted eczemaDay 15
Change from Baseline in severity assessment by Investigator's Global Assessment (IGA)Day 15
Change from Baseline in intensity of pruritusDay 15

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