NCT01368315

CT 327 in the "Atopy Patch Test" Model

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Creabilis SA · Industry
• Sex: All
• Age: 18 Years – 66 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	CT327 application	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.
DRUG	Placebo	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.
DRUG	Active comparator	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.
DRUG	No intervention	No intervention to one out of four test fields marked on the patient's back.

Timeline

• First posted: 2011-06-07
• Last updated: 2011-06-07

Locations

1 site across 1 country: Germany