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Dose Escalation of Different Concentrations of ZK 245186 in Atopic Dermatitis

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Bayer

Status and phase

Completed
Phase 2

Conditions

Atopic Dermatitis

Treatments

Drug: Placebo (vehicle ointment)
Drug: ZK 245186

Study type

Interventional

Funder types

Industry

Identifiers

NCT00944632
1402942 (Other Identifier)
14501

Details and patient eligibility

About

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.

Enrollment

64 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

64 participants in 4 patient groups, including a placebo group

Zk 245186 0.01% ointment
Active Comparator group
Description:
Active treatment, lowest dose
Treatment:
Drug: ZK 245186
ZK 245186 0.03% ointment
Active Comparator group
Description:
Active comparator middle dose
Treatment:
Drug: ZK 245186
ZK 245186 0.1% ointment
Active Comparator group
Description:
Active comparator highest dose
Treatment:
Drug: ZK 245186
Vehicle ointment
Placebo Comparator group
Description:
Placebo comparator
Treatment:
Drug: Placebo (vehicle ointment)

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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