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

Bayer

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: ZK245186; Drug: Placebo (vehicle without active ingredient)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01228513

15267

1403380 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 263 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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263 participants in 4 patient groups, including a placebo group

0.01% ointment

Active Comparator group

Description:

Lowest concentration

Treatment:

Drug: ZK245186

0.03% ointment

Active Comparator group

Description:

Middle concentration

Treatment:

Drug: ZK245186

0.1% ointment

Active Comparator group

Description:

Highest concentration

Treatment:

Drug: ZK245186

Placebo (vehicle without active)

Placebo Comparator group

Description:

No active ingredient

Treatment:

Drug: Placebo (vehicle without active ingredient)