CT 327 in the Treatment of Atopic Dermatitis

Phase 2

Terminated

• Conditions: Mild to Moderate Atopic Dermatitis
• Interventions: Drug: placebo; Drug: CT 327

• Registration Number: NCT00996008
• Lead Sponsor: Creabilis SA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-15
• Study First Submitted QC: 2009-10-15
• Study First Posted: 2009-10-16
• Study Start: 2009-11
• Status Verified: 2010-10
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Last Update Submitted: 2010-10-25
• Last Update Posted: 2010-10-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo only	placebo	Subjects will apply placebo cream to all 4 target lesions
Active plus placebo	CT 327	Subjects will receive CT 327 on 2 of 4 target lesions located on one side of their body. On the remaining 2 target lesions on the other side of their body, placebo will be applied.

Primary Outcome Measures

Name	Time	Method
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	14 days

Secondary Outcome Measures

Name	Time	Method
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	14 days

Trial Locations

Locations (4)

Inselspital; 🇨🇭 Bern, Switzerland

Kantonsspital St Gallen; 🇨🇭 St Gallen, Switzerland

University Hospital; 🇨🇭 Zürich, Switzerland

CHUV, Hôpital de Beaumont; 🇨🇭 Lausanne, Switzerland