Dose Escalation of Different Concentrations of ZK 245186 in Atopic Dermatitis

Double-blind, Randomized, Dose Escalation Study of the Efficacy and Safety of ZK 245186 Ointment in Concentrations of 0.01%, 0.03%, and 0.1% Over 4 Weeks in Patients With Atopic Dermatitis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00944632

Enrollment

Registered

2009-07-23

Start date

2009-07-15

Completion date

2010-09-15

Last updated

2023-06-07

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 determine the safety and efficacy of three concentrations of ZK 245186 ointment and vehicle on increasing body surface areas for the treatment of atopic dermatitis and to obtain dose-response information for the three concentrations.

Interventions

DRUGZK 245186

Once daily topical non-occlusive application for up to 4 weeks

DRUGPlacebo (vehicle ointment)

Once daily topical non-occlusive application for up to 4 weeks

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 (Hanifin and Rajka criteria) * mild to moderate atopic dermatitis at beginning of study * wash-out periods for systemic and topical treatments for atopic dermatitis * females must use effective contraception

Exclusion criteria

* pregnant or lactating women * conditions that in the opinion of the investigator may pose a risk or interfere with the evaluation of the study * wide-spread atopic dermatitis requiring systemic treatment * diagnosed with immunocompromised status * skin diseases - other than atopic dermatitis - in the treatment area * mental handicap or legally incompetent

Design outcomes

Primary

Measure	Time frame
Assessment of the severity of atopic dermatitis at target lesion, based on clinical signs of inflammation	up to 4 weeks

Secondary

Measure	Time frame
Investigator's Global Assessment of target area	up to 4 weeks

Countries

South Africa

Outcome results

None listed

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