Tolerability Study of the Application of a 3M Microstructure Transdermal System

Summary

The purpose of this study is to evaluate the safety and tolerability of an experimental device that introduces microscopic channels into the skin. Creating microscopic channels in the skin allows for better absorption of various medications applied to the skin, and this study will determine if the study device offers a tolerable method by which to introduce these holes. The study population will include 54 individuals, ages 18-74 years old, with a roughly equal distribution of skin colors. Each subject will have a total of three visits 24 hours apart from one another. The study device will be applied at the Baseline and Day 1 visits. At various timepoints before and after device application, skin assessments for irritation will be completed using a 7-point Skin Reaction Scale and photographs will be taken. Subjects will report pain associated with device application using a standardized pain scale. At the baseline visit, a member of the research staff will administer applications of the study device on the side of the subject's forehead, temple and the area below and to the side of the nose on randomly selected sides of the face. The side of the face at each location not receiving application of the study device will receive applications of a "dummy" device. Subjects will not be informed of which device is the study device and which is the "dummy" device. At the Day 1 visit, a member of the research staff will administer study device applications to the center of the subject's forehead. The subject will also self-apply the study device to the chin, under the instruction of the research staff member. At the Day 2 visit, final skin assessments will be made and the subject will be evaluated and treated for any persistent skin irritation. Differences in skin irritation between sites of study device application and "dummy" device application will be determined, as well as several other endpoints.

Conditions

• Healthy

Interventions

DEVICE

Transdermal Microchannel Skin System

A member of the research staff will apply the study device to the subject's lateral forehead, temple and nasolabial area on randomly selected sides of the face, 3 times at each anatomical location, for a total of 9 applications. All subjects will also receive 9 adjacent applications to the central forehead, and they will self-administer 3 adjacent applications to the chin under instruction of study staff.

DEVICE

Sham device

The side not receiving application of the study device at each anatomical location will receive a comparable number of applications of a sham device.

Sponsors & Collaborators

• 3M

  collaborator INDUSTRY

• Northwestern University

  lead OTHER

Principal Investigators

• Dennis P West, PhD · Northwestern University

• Murad Alam, MD · Northwestern University

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

74 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-05-31

Primary Completion

2011-04-30

Completion

2011-04-30

Countries

• United States

Study Locations