Efficacy and Safety of Different Concentrations of ZK245186 in Atopic Dermatitis (AD)

Double-blind, Randomized, Vehicle-controlled, Multicenter, Multinational, Parallel-group Study of the Efficacy and Safety of ZK245186 Ointment in Concentrations of 0.01, 0.03, and 0.1% Over 4 Weeks in Patients With Atopic Dermatitis (AD)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01228513

Enrollment

263

Registered

2010-10-26

Start date

2010-11-30

Completion date

2012-04-30

Last updated

2016-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Brief summary

The purpose of this study is to evaluate the efficacy and safety of three concentrations of a development drug compared to placebo in the treatment of atopic dermatitis.

Interventions

DRUGZK245186

Daily topical application

DRUGPlacebo (vehicle without active ingredient)

Daily topical application

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

* Diagnosis of atopic dermatitis according to Hanifin and Rajka criteria * Body surface area affected by atopic dermatitis at or less than 15% at start of treatment

Exclusion criteria

* Pregnancy and breast-feeding * Conditions that may pose a threat to the patient or effect the outcome of the study * Wide-spread atopic dermatitis (AD) requiring systemic treatment * Immuno-compromized conditions * At least 2 weeks after local AD treatment and treatment with systemic antibiotics * At least 1 month after systemic AD treatment

Design outcomes

Primary

Measure	Time frame	Description
Eczema Area and Severity Index (EASI)	At baseline	Eczema area and severity index
EASI	Measured after one week of treatment	Ezcema area and severity index

Secondary

Measure	Time frame	Description
Subjects' assessment of pruritus	Measured at baseline	Subjective measurement on a point scale
Subject's assessment of pruritus	Measured after one week of treatment	Subjective measurement on a point scale

Countries

Japan, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026