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

Study Overview
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Brief Summary
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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.

Official Title
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Tolerability Study of the Application of a 3M Microstructure Transdermal System by Finger Pressure to the Face in Healthy Subjects Stratified by Age and Fitzpatrick Skin Type

Conditions
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Healthy

Intervention / Treatment
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* Device: Transdermal Microchannel Skin System
* Device: Sham device


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study device<br>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. | Device: Transdermal Microchannel Skin System<br>* 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.<br>|
| Sham Comparator: Sham device<br>The sham device will be very similar in appearance to the study device. The sham device arm will receive application of this device. | Device: Sham device<br>* The side not receiving application of the study device at each anatomical location will receive a comparable number of applications of a sham device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local skin reaction scores | 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. | 48 hours | 
| Median pain scores | Difference in median pain scores between Study Device side and Control side for any of the three facial application sites. | 5 minutes | 
| Local skin reaction and reported pain central forehead | Reported pain and change in skin irritation at the central forehead site. | 24 hours | 
| Local skin reaction score and reported pain chin | Reported pain and change in skin irritation at the chin site. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Max difference in skin reaction score | Maximal difference in local skin reaction score at any follow-up visit | 48 hours | 
| Subject questionnaire differences | Reported differences in skin irritation or side-effects reported per patient questionnaire | 48 hours | 
| Differences between skin type groupings | 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). | 48 hours | 
| Differences between age groups | 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). | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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needles/adverse effects, administration, cutaneous, erythema, pain measurement, Safety, Microstructure Transdermal System