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CT 327 in the Treatment of Atopic Dermatitis

Primary Purpose

Mild to Moderate Atopic Dermatitis

Status

Terminated

Phase

Phase 2

Locations

Switzerland

Study Type

Interventional

Intervention

placebo

CT 327

About this trial

This is an interventional treatment trial for Mild to Moderate Atopic Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital
Inselspital
CHUV, Hôpital de Beaumont
Kantonsspital St Gallen
University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo only

Active plus placebo

Arm Description

Subjects will apply placebo cream to all 4 target lesions

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00996008

First Posted

October 15, 2009

Last Updated

October 25, 2010

Sponsor

Creabilis SA

1. Study Identification

Unique Protocol Identification Number

NCT00996008

Brief Title

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

2. Study Status

Record Verification Date

October 2010

Overall Recruitment Status

Terminated

Why Stopped

Due to slow recruitment, study was stopped before target enrollment was achieved

Study Start Date

November 2009 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Creabilis SA

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild to Moderate Atopic Dermatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo only

Arm Type

Placebo Comparator

Arm Description

Subjects will apply placebo cream to all 4 target lesions

Arm Title

Active plus placebo

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

0.5 g (w/w) placebo cream applied to each target lesion twice daily

Intervention Type

Drug

Intervention Name(s)

CT 327

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Frame

14 days

Secondary Outcome Measure Information:

Title

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

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

University Hospital

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Facility Name

Inselspital

City

Bern

ZIP/Postal Code

CH-3010

Country

Switzerland

Facility Name

CHUV, Hôpital de Beaumont

City

Lausanne

ZIP/Postal Code

CH-1011

Country

Switzerland

Facility Name

Kantonsspital St Gallen

City

St Gallen

ZIP/Postal Code

CH-9007

Country

Switzerland

Facility Name

University Hospital

City

Zürich

ZIP/Postal Code

CH-8091

Country

Switzerland

12. IPD Sharing Statement

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CT 327 in the Treatment of Atopic Dermatitis

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