A Randomized, Double-Blind, Phase I, Single-Center Study on the Efficacy and Safety of CT 327 in the Atopy Patch Test model.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
20
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.
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.
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.
Klinik und Poliklinik für Dermatologie und Allergologie Am Biederstein Technische Universität München
Munich, Germany
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
Local and systemic tolerance of CT 327
Time frame: 7 weeks
Plasma CT327 levels
Time frame: 10 days
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No intervention to one out of four test fields marked on the patient's back.