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

Primary Purpose

Atopic Dermatitis

Status

Withdrawn

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

CT327 application

Placebo

Active comparator

No intervention

About this trial

This is an interventional basic science trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 66 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Active Comparator

No Intervention

Arm Label

CT327

Placebo

Active comparator

No intervention

Arm Description

Cream

Cream (Vehicle only)

Cream

Outcomes

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

Secondary Outcome Measures

Local and systemic tolerance of CT 327

Plasma CT327 levels

Full Information

NCT ID

NCT01368315

First Posted

June 6, 2011

Last Updated

June 6, 2011

Sponsor

Creabilis SA

1. Study Identification

Unique Protocol Identification Number

NCT01368315

Brief Title

CT 327 in the "Atopy Patch Test" Model

Acronym

CT327 AD01-09

Official Title

CT 327 in the "Atopy Patch Test" Model

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Withdrawn

Why Stopped

Strategic decision

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Creabilis SA

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CT327

Arm Type

Experimental

Arm Description

Cream

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Cream (Vehicle only)

Arm Title

Active comparator

Arm Type

Active Comparator

Arm Description

Cream

Arm Title

No intervention

Arm Type

No Intervention

Intervention Type

Drug

Intervention Name(s)

CT327 application

Intervention Description

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

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Name(s)

Active comparator

Intervention Description

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

Intervention Name(s)

No intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Local and systemic tolerance of CT 327

Time Frame

7 weeks

Title

Plasma CT327 levels

Time Frame

10 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

66 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Prof. Dr. Med. Johannes Ring

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Munich

ZIP/Postal Code

D-80802

Country

Germany

12. IPD Sharing Statement

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CT 327 in the "Atopy Patch Test" Model

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