Test Uniformity of Transdermal Drug Delivery to Breast Using Diclofenac Epolamine

NCT01380353 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-02-19

No results posted yet for this study

Summary

The purpose of this study is to look for ways to improve breast cancer treatment by giving breast cancer drugs through the skin of the breast.

The drug used in this study is a diclofenac epolamine patch and is a nonsteroid anti-inflammatory pain reliever. The drug amount that gathers in the breast, after application of a patch to the skin of the breast, will be measured and compared to the amount that is found in the breast when the patch is applied to the skin of the belly.

Conditions

Interventions

DRUG

Diclofenac epolamine patch

Patch (10cm X 14cm) is comprised of an adhesive material containing 1.3% diclofenac epolamine which is applied to a non-woven polyester felt backing and covered with a polypropylene film release liner \[B\].

Sponsors & Collaborators

Principal Investigators

  • Seema Khan, MD · Northwestern University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-11-12
Completion
2012-11-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01380353 on ClinicalTrials.gov