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CT 327 in the "Atopy Patch Test" Model (CT327 AD01-09)

This study has been withdrawn prior to enrollment.
(Strategic decision)
Sponsor:
Information provided by:
Creabilis SA
ClinicalTrials.gov Identifier:
NCT01368315
First received: June 6, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

A Randomized, Double-Blind, Phase I, Single-Center Study on the Efficacy and Safety of CT 327 in the Atopy Patch Test model.


Condition Intervention Phase
Atopic Dermatitis
Drug: CT327 application
Drug: Placebo
Drug: Active comparator
Drug: No intervention
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: CT 327 in the "Atopy Patch Test" Model

Further study details as provided by Creabilis SA:

Primary Outcome Measures:
  • Result of the Atopy Patch Test (APT): measurement of the eczematous skin reaction (score) after challenge with the appropriate aeroallergen, using European Task Force on Atopic Dermatitis criteria [ Time Frame: 13 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Local and systemic tolerance of CT 327 [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]
  • Plasma CT327 levels [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Arms Assigned Interventions
Experimental: CT327
Cream
Drug: CT327 application
Topical administration of 0.5 grams cream administered twice daily for ten days to one out of four test fields marked on the patient's back.
Placebo Comparator: Placebo
Cream (Vehicle only)
Drug: Placebo
Topical administration of 0.5 grams cream administered twice daily for ten days to one out of four test fields marked on the patient's back.
Active Comparator: Active comparator
Cream
Drug: Active comparator
Topical administration of an active comparator administered twice daily for ten days to one out of four test fields marked on the patient's back.
No Intervention: No intervention Drug: No intervention
No intervention to one out of four test fields marked on the patient's back.

Detailed Description:

The study population will include subjects with atopic dermatitis (AD) and a positive atopy patch test (APT) test at study screening. Positive responders to the APT test will enter into a treatment period of ten days during which all subjects will have three test compounds (CT 327, Placebo or an active comparator) administered twice daily to three test fields marked on patient's back. A fourth test field will act as untreated control. A challenge with the relevant aeroallergen to which the subject is responding most strongly, as assessed at screening, will take place on Day 10. Readings of APT scores will be performed at 48 and 72 hrs after the challenge and the subjects will have a end-of-study visit 2 weeks later. Local and systemic tolerance of CT327 will be assessed during the study, in addition to its potential absorption into the systemic circulation. The effects of CT327 on modulating the immune response to aeroallergens and on the expression of immunological and inflammatory markers on biopsies of the treated areas will also be evaluated.

  Eligibility

Ages Eligible for Study:   18 Years to 66 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 and < 66 years of age
  • Able to give informed consent
  • Diagnosis of atopic dermatitis and a positive atopy patch test to at least one of the following(Dermaphagoides pteronyssinus, cat dander, grass or birch pollen)

Exclusion Criteria:

  • Have concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug
  • Have a positive response to petrolatum
  • Be immune-compromised
  • Have any clinically significant abnormal clinical laboratory test results at Screening
  • Have a history of malignancy except basal cell carcinoma of the skin.
  • Have an active intercurrent infection
  • Have applied any topical medication (including corticosteroid, calcineurin inhibitor, topical H1 and H2 antihistamines, topical antimicrobials, other medicated topical agents) or herbal preparation to the area selected for treatment within 14 days prior to study entry.
  • Have received antibiotic treatment within 1 week prior to study entry
  • 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).
  • Have received any investigational drug or been part of any clinical study within the last three months before study entry.
  • Have a history of hypersensitivity or allergic reactions to any ingredient in the CT 327 formulation or to the selected active comparator or to polyethyleneglycol.
  • If female, are pregnant or lactating, or intend to become pregnant during the study period
  • If female, and of child-bearing potential, not taking adequate contraception to avoid pregnancy during and three months after the study.
  • History of drug, alcohol or other substance abuse or other factors limiting the ability to cooperate and to comply with the study protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368315

Locations
Germany
Klinik und Poliklinik für Dermatologie und Allergologie Am Biederstein Technische Universität München
Munich, Germany, D-80802
Sponsors and Collaborators
Creabilis SA
Investigators
Principal Investigator: Prof. Dr. Med. Johannes Ring Klinik und Poliklinik für Dermatologie und Allergologie Am Biederstein, Technische Universität München, Munich, Germany
  More Information

No publications provided

Responsible Party: Dr. Eduard Vidovic, Chief Medical Officer, Creabilis
ClinicalTrials.gov Identifier: NCT01368315     History of Changes
Other Study ID Numbers: CT 327 AD 01-09
Study First Received: June 6, 2011
Last Updated: June 6, 2011
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices (BfArM)

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

ClinicalTrials.gov processed this record on November 25, 2014