MedDataX Logo

CT 327 in the Treatment of Atopic Dermatitis

NCT ID: NCT00996008

Last Updated: 2010-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mild to Moderate Atopic Dermatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo only

Subjects will apply placebo cream to all 4 target lesions

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Active plus placebo

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.

Group Type ACTIVE_COMPARATOR

CT 327

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

placebo

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

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Creabilis SA

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University Hospital, Basel

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital

Basel, , Switzerland

Site Status

Inselspital

Bern, , Switzerland

Site Status

CHUV, Hôpital de Beaumont

Lausanne, , Switzerland

Site Status

Kantonsspital St Gallen

Sankt Gallen, , Switzerland

Site Status

University Hospital

Zurich, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CT 327 AD 02-09

Identifier Type: -

Identifier Source: org_study_id