CT 327 in the "Atopy Patch Test" Model

NCT ID: NCT01368315

Last Updated: 2011-06-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL

Brief Summary

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

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

CT327

Cream

Group Type: EXPERIMENTAL

CT327 application

Intervention Type: DRUG

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

Cream (Vehicle only)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Cream

Group Type: ACTIVE_COMPARATOR

Active comparator

Intervention Type: DRUG

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

Group Type: NO_INTERVENTION

No intervention

Intervention Type: DRUG

No intervention to one out of four test fields marked on the patient's back.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

No intervention

No intervention to one out of four test fields marked on the patient's back.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 66 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Creabilis SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Creabilis

Principal Investigators

Prof. Dr. Med. Johannes Ring

Role: PRINCIPAL_INVESTIGATOR

Klinik und Poliklinik für Dermatologie und Allergologie Am Biederstein, Technische Universität München, Munich, Germany

Locations

Klinik und Poliklinik für Dermatologie und Allergologie Am Biederstein Technische Universität München

Munich, , Germany

Countries

Germany

Other Identifiers

CT 327 AD 01-09

Identifier Type: -

Identifier Source: org_study_id