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

Creabilis

Status and phase: Withdrawn; Phase 1

Conditions: Atopic Dermatitis

Treatments: Drug: Active comparator; Drug: Placebo; Drug: No intervention; Drug: CT327 application

Study type: Interventional

Funder types: Industry

Identifiers

NCT01368315

CT 327 AD 01-09

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 66 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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20 participants in 4 patient groups, including a placebo group

CT327

Experimental group

Description:

Cream

Treatment:

Drug: CT327 application

Placebo

Placebo Comparator group

Description:

Cream (Vehicle only)

Treatment:

Drug: Placebo

Active comparator

Active Comparator group

Description:

Cream

Treatment:

Drug: Active comparator

No intervention

No Intervention group

Treatment:

Drug: No intervention