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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Device: Transdermal Microchannel Skin System; Device: Sham device

• Registration Number: NCT01257763
• Lead Sponsor: Northwestern University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-12-08
• Study First Submitted QC: 2010-12-09
• Study First Posted: 2010-12-10
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-30
• Last Update Posted: 2021-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Age 18-74 years old
• Subject in good health as determined by the investigator
• Subject has the willingness and the ability to understand and provide informed consent and communicate with the investigator

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Exclusion Criteria

• Subjects with active systemic or skin disease (including acne) or skin infection that could, in the opinion of the investigator, interfere with accurate study assessments
• Baseline skin irritation as defined by a local skin reaction score greater than "0" at any of the application areas (Appendix 1)
• Facial cosmetic procedures performed within 4 weeks of the baseline visit that may, in the opinion of the investigator, have an impact on skin assessment results†
• Topical medications applied to the face within 2 weeks of the baseline visit that may, in the opinion of the investigator, have an impact on skin assessment results†
• Subjects with skin disease such as atopic dermatitis, urticaria or dermatographism that may be exacerbated by device application †Subjects may enroll after a corresponding washout period

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study device	Transdermal Microchannel Skin System	The study device is a transdermal microneedle array designed to introduce microscopic channels into the skin. The study device arm will receive application of this device.
Sham device	Sham device	The sham device will be very similar in appearance to the study device. The sham device arm will receive application of this device.

Primary Outcome Measures

Name	Time	Method
Median pain scores	5 minutes	Difference in median pain scores between Study Device side and Control side for any of the three facial application sites.
Local skin reaction and reported pain central forehead	24 hours	Reported pain and change in skin irritation at the central forehead site.
Local skin reaction scores	48 hours	Difference in median local skin reaction scores between Study Device side and Control side for any of the three facial application sites at any of the seven follow-up times.
Local skin reaction score and reported pain chin	24 hours	Reported pain and change in skin irritation at the chin site.

Secondary Outcome Measures

Name	Time	Method
Max difference in skin reaction score	48 hours	Maximal difference in local skin reaction score at any follow-up visit
Differences between skin type groupings	48 hours	Differences in reported pain or changes in local skin reaction score at central forehead site between the 3 Fitzpatrick skin type groupings (I-II, III-IV and V-VI).
Subject questionnaire differences	48 hours	Reported differences in skin irritation or side-effects reported per patient questionnaire
Differences between age groups	48 hours	Differences in reported pain or changes in local skin reaction score at central forehead site between 3 age groupings (18-35, 36-60, 61-74).

Trial Locations

Locations (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology; 🇺🇸 Chicago, Illinois, United States