CT 327 in the Atopy Patch Test Model

Study Overview
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Brief Summary
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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
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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.

Official Title
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CT 327 in the Atopy Patch Test Model

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: CT327 application
* Drug: Placebo
* Drug: Active comparator
* Drug: No intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 66 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT327<br>Cream | Drug: CT327 application<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Cream (Vehicle only) | Drug: Placebo<br>* 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.<br>|
| Active Comparator: Active comparator<br>Cream | Drug: Active comparator<br>* 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.<br>|
| No Intervention: No intervention<br> | Drug: No intervention<br>* No intervention to one out of four test fields marked on the patient's back.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 13 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local and systemic tolerance of CT 327 |  | 7 weeks | 
| Plasma CT327 levels |  | 10 days |