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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study device | Experimental | 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. |
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| Sham device | Sham Comparator | The sham device will be very similar in appearance to the study device. The sham device arm will receive application of this device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transdermal Microchannel Skin System | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis P West, PhD | Northwestern University | Study Director |
| Murad Alam, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine, Department of Dermatology | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22431712 | Derived | Hoesly FJ, Borovicka J, Gordon J, Nardone B, Holbrook JS, Pace N, Ibrahim O, Bolotin D, Warycha M, Kwasny M, West D, Alam M. Safety of a novel microneedle device applied to facial skin: a subject- and rater-blinded, sham-controlled, randomized trial. Arch Dermatol. 2012 Jun;148(6):711-7. doi: 10.1001/archdermatol.2012.280. |
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| ID | Term |
|---|---|
| D004890 | Erythema |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| Sham device | 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. |
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| 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 |
| D013568 | Pathological Conditions, Signs and Symptoms |