Trial Condition(s):
Atopic dermatitis
Dose Escalation of Different Concentrations of ZK 245186 in Atopic Dermatitis
Bayer Identifier:
14501
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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 Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations PAREXEL International (Bloemfontein) Bloemfontein, South Africa, 9301 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations PAREXEL International (George) George, South Africa, 6529 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations PAREXEL International (Port Elizabeth) Newton Park, South Africa, 6045 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
4
Primary Outcome
- Assessment of the severity of atopic dermatitis at target lesion, based on clinical signs of inflammationTimeframe: up to 4 weeks
Secondary Outcome
- Investigator's Global Assessment of target areaTimeframe: up to 4 weeks
Additional Information
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