Status:
TERMINATED
CT 327 in the Treatment of Atopic Dermatitis
Lead Sponsor:
Creabilis SA
Conditions:
Mild to Moderate Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will look at how safe and effective, a novel agent, CT 327 cream is in treating patients with mild to moderate atopic dermatitis (AD). Patients will be treated twice daily for 14 days on sp...
Eligibility Criteria
Inclusion
- Male and Female subjects aged \>18 year
- Written informed consent
- Mild to moderate AD at baseline (EASI score of at least 2 or 3)
- Active AD (visible eczema, erythema and pruritus)
- Presence of at least four target lesions (symmetrically) at inclusion (ideally at the elbow flexions and knee bends)
Exclusion
- If female of childbearing potential not using an adequate and appropriate form of contraception such as oral contraceptive; intra-uterine device (IUD); contraceptive injection, implant or patch
- If female, are pregnant or lactating, or intend to become pregnant during the study period
- Allergy to test drug or excipients
- Usage of topical corticosteroids or other topical treatments for AD within the last two weeks prior to study entry (including calcineurin inhibitor, topical H1 and H2 antihistamines, topical antimicrobials, other medicated topical agents) or herbal preparation to the area selected for treatment
- Within 4 weeks prior to study entry, have received systemic treatment for atopic dermatitis (including systemic corticosteroids, nonsteroidals, immunosuppressants, or immunomodulating drugs, or treatment with light).
- Presence of major medical illness requiring systemic therapy including cancers
- Clinical diagnosis of bacterial infection of the skin including impetigo and abscesses
- Any clinical relevant ECG abnormality
- Have any clinically significant abnormal clinical laboratory test results at screening
- Received any investigational drug or taking part in any clinical study within three months prior to this study
- History of drug, alcohol or other substance abuse or other factors limiting the ability to co-operate and to comply with this protocol
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00996008
Start Date
November 1 2009
End Date
October 1 2010
Last Update
October 26 2010
Active Locations (5)
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1
University Hospital
Basel, Switzerland, 4031
2
Inselspital
Bern, Switzerland, CH-3010
3
CHUV, Hôpital de Beaumont
Lausanne, Switzerland, CH-1011
4
Kantonsspital St Gallen
Sankt Gallen, Switzerland, CH-9007