CT 327 in the Treatment of Atopic Dermatitis

NCT00996008 | Terminated Phase 2

• 1 other identifier: CT 327 AD 02-09
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 5

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.

Conditions

Mild to Moderate Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Placebo only

PLACEBO COMPARATOR

Subjects will apply placebo cream to all 4 target lesions

Drug: placebo

Active plus placebo

ACTIVE COMPARATOR

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.

Drug: CT 327

Interventions

placebo DRUG

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

Placebo only

CT 327 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

Active plus placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Creabilis SA: lead

Study Sites (5)

University Hospital

Basel, 4031, Switzerland

Location

Inselspital

Bern, CH-3010, Switzerland

Location

CHUV, Hôpital de Beaumont

Lausanne, CH-1011, Switzerland

Location

Kantonsspital St Gallen

Sankt Gallen, CH-9007, Switzerland

Location

University Hospital

Zurich, CH-8091, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 15, 2009
• First Posted: October 16, 2009
• Study Start: November 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: October 26, 2010

Record last verified: 2010-10

Locations

CH (5)