Conditions: Atopic Dermatitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 41
Healthy volunteers: no

Brief summary:
The primary objective of this study was to evaluate microbial density in eczematous lesions during two weeks of twice daily therapy with the investigational product, DPK-060 1% ointment, compared with placebo in patients with atopic dermatitis. This randomized, double-blind, placebo-controlled part of the study was preceded with an open-label investigation in a small group of patients (n=5) treated with two applications of DPK-060 1% ointment per day for four days to assess safety, local tolerability and systemic absorption of DPK-060.

The secondary objectives were to evaluate severity of eczema and pruritus, to assess the tolerability and safety of the treatment and to assess the degree of systemic absorption of DPK-060 in blood on Day 7 and Day 21 in a sub-set of 10 patients.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: DPK-060 1% ointment intervention 2: Placebo for DPK-060 ointment
Intervention descriptions: intervention 1: DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2 intervention 2: Placebo for DPK-060 ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2

Protocol document: