CT 327 in the Treatment of Atopic Dermatitis

Mild to Moderate Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00996008
• Other study ID #: CT 327 AD 02-09
• Status: Terminated
• Phase: Phase 2
• First received: October 15, 2009
• Last updated: October 25, 2010
• Start date: November 2009
• Est. completion date: October 2010

Study information

• Verified date: October 2010
• Source: Creabilis SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema
• Mild to Moderate Atopic Dermatitis

Intervention

Drug:
• placebo
0.5 g (w/w) placebo cream applied to each target lesion twice daily
• CT 327
0.5 g CT 327 cream will be applied to 2 target lesions twice daily 0.5 g placebo cream will be applied to remaining 2 target lesions twice daily

Locations

Country	Name	City	State
Switzerland	University Hospital	Basel
Switzerland	Inselspital	Bern
Switzerland	CHUV, Hôpital de Beaumont	Lausanne
Switzerland	Kantonsspital St Gallen	St Gallen
Switzerland	University Hospital	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Creabilis SA

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No