CT 327 in the "Atopy Patch Test" Model

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Creabilis SA

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