Dose Escalation of Different Concentrations of ZK 245186 in Atopic Dermatitis
This study has been completed.
Sponsor:
Intendis GmbH
Information provided by:
Intendis GmbH
ClinicalTrials.gov Identifier:
NCT00944632
First received: July 22, 2009
Last updated: October 5, 2010
Last verified: October 2010
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Atopic Dermatitis |
Drug: ZK 245186 Drug: Placebo (vehicle ointment) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
Further study details as provided by Intendis GmbH:
Primary Outcome Measures:
- Assessment of the severity of atopic dermatitis at target lesion, based on clinical signs of inflammation [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Investigator's Global Assessment of target area [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 64 |
| Study Start Date: | July 2009 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Zk 245186 0.01% ointment
Active treatment, lowest dose
|
Drug: ZK 245186
Once daily topical non-occlusive application for up to 4 weeks
|
|
Active Comparator: ZK 245186 0.03% ointment
Active comparator middle dose
|
Drug: ZK 245186
Once daily topical non-occlusive application for up to 4 weeks
|
|
Active Comparator: ZK 245186 0.1% ointment
Active comparator highest dose
|
Drug: ZK 245186
Once daily topical non-occlusive application for up to 4 weeks
|
|
Placebo Comparator: Vehicle ointment
Placebo comparator
|
Drug: Placebo (vehicle ointment)
Once daily topical non-occlusive application for up to 4 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Dr Kathrin Vick, Intendis GmbH |
| ClinicalTrials.gov Identifier: | NCT00944632 History of Changes |
| Other Study ID Numbers: | 1402942 |
| Study First Received: | July 22, 2009 |
| Last Updated: | October 5, 2010 |
| Health Authority: | South Africa: Department of Health |
Additional relevant MeSH terms:
|
Dermatitis Dermatitis, Atopic Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn |
Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013