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

Otsuka

Status and phase: Completed; Phase 1

Conditions: Atopic Dermatitis

Treatments: Drug: Tacrolimus; Drug: OPA-15406; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01702181

271-12-204

Details and patient eligibility

About

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

Enrollment: 92 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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92 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Matching placebo.

Treatment:

Drug: Placebo

Tacrolimus

Active Comparator group

Description:

Tacrolimus 0.1% ointment twice daily for 28 days.

Treatment:

Drug: Tacrolimus

OPA-15406

Experimental group

Treatment:

Drug: OPA-15406