A Safety Study to Evaluate the Use and Effectiveness of a Topical Ointment to Treat Adults With Atopic Dermatitis



Status:Completed
Conditions:Psoriasis, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 65
Updated:1/1/2014
Start Date:August 2012
End Date:December 2013
Contact:Emilie Reed
Email:ereed@tklresearch.com
Phone:201-587-0500

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A Multiple-Dose (0.3%, 1%, and 3% [w/w]), Randomized, Blinded, Vehicle- and Active Comparator-Controlled, Sequential Dose Cohorts, Multi-Center Trial to Assess the Safety, Pharmacokinetics, and Proof-of-Concept Efficacy of Topical OPA 15406 Ointment, Applied Twice Daily for 28 Days, in Adult Subjects With Atopic Dermatitis

The purpose of this study is to investigate the pharmacokinetics and safety of OPA-15406 in
adult subjects with atopic dermatitis


Inclusion Criteria:

- Adult subjects 18-65 years of age

- Diagnosis of atopic dermatitis (AD)

- AD affecting at least 5% of total Body Surface Area (BSA) for Part 1 and at least 10%
BSA for Part 2, not including face, neck, and head

- Have had a positive but inadequate response to one or more treatment course of
standard AD therapy including topical steroids, UV light A, narrowband UV B, and UV
light B.

Exclusion Criteria:

- Females pregnant or breast-feeding

- Sexually active subjects who are not practicing acceptable birth control methods

- Use of systemic or topical therapy for contact or atopic dermatitis within 30 days of
screening

- Phototherapy within 30 days of screening

- Use of oral or topical antihistamines within 7 days of first dose.
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