CT 327 in the Treatment of Atopic Dermatitis

This study has been terminated.
(Due to slow recruitment, study was stopped before target enrollment was achieved)
Sponsor:
Information provided by:
Creabilis SA
ClinicalTrials.gov Identifier:
NCT00996008
First received: October 15, 2009
Last updated: October 25, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Mild to Moderate Atopic Dermatitis
Drug: placebo
Drug: CT 327
Phase 2

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

Further study details as provided by Creabilis SA:

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 [ Time Frame: 14 days ] [ Designated as safety issue: No ]

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 [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: November 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo only
Subjects will apply placebo cream to all 4 target lesions
Drug: placebo
0.5 g (w/w) placebo cream applied to each target lesion twice daily
Active Comparator: 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.
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00996008

Locations
Switzerland
University Hospital
Basel, Switzerland, 4031
Inselspital
Bern, Switzerland, CH-3010
CHUV, Hôpital de Beaumont
Lausanne, Switzerland, CH-1011
Kantonsspital St Gallen
St Gallen, Switzerland, CH-9007
University Hospital
Zürich, Switzerland, CH-8091
Sponsors and Collaborators
Creabilis SA
  More Information

No publications provided

Responsible Party: Professor Peter Itin, University Hospital, Basel
ClinicalTrials.gov Identifier: NCT00996008     History of Changes
Other Study ID Numbers: CT 327 AD 02-09
Study First Received: October 15, 2009
Last Updated: October 25, 2010
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014