Clinical trial NCT00996008: CT 327 in the Treatment of Atopic Dermatitis
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study of the Safety and Efficacy of CT 327, Pegylated K-252, Formulated as a Cream, When Administered Twice Daily for 14 Days to Subjects With Mild-to-Moderate Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Mild to Moderate Atopic Dermatitis
Lead sponsor: Creabilis SA
Sponsor class: INDUSTRY
First posted: 2009-10-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 specific lesions of AD and safety and symptoms of AD will be assessed throughout the treatment period.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: To assess the efficacy of CT 327 vs Placebo in terms of improvements from baseline on Modified Eczema Area Severity Index (mEASI) score: Proportion of subjects with a reduction in mEASI-score of ≥ 50% on day 14
timeFrame: 14 days
Secondary outcomes:
measure: To assess the efficacy of a 14-days treatment of CT 327 vs Placebo in terms of improvements from baseline on: Proportion of subjects with a reduction in m-EASI-score of > 75% on day 14
timeFrame: 14 days
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital
city: Bern
country: Switzerland
facility: Inselspital
city: Lausanne
country: Switzerland
facility: CHUV, Hôpital de Beaumont
city: St Gallen
country: Switzerland
facility: Kantonsspital St Gallen
city: Zürich
country: Switzerland
facility: University Hospital
Study officials:
References: