Tolerability Study of the Application of a 3M Microstructure Transdermal System
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|ClinicalTrials.gov Identifier: NCT01257763|
Recruitment Status : Completed
First Posted : December 10, 2010
Last Update Posted : September 17, 2012
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Device: Transdermal Microchannel Skin System Device: Sham device||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
Experimental: Study device
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
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.
Sham Comparator: 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.
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.
- Local skin reaction scores [ Time Frame: 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.
- Median pain scores [ Time Frame: 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 [ Time Frame: 24 hours ]Reported pain and change in skin irritation at the central forehead site.
- Local skin reaction score and reported pain chin [ Time Frame: 24 hours ]Reported pain and change in skin irritation at the chin site.
- Max difference in skin reaction score [ Time Frame: 48 hours ]Maximal difference in local skin reaction score at any follow-up visit
- Subject questionnaire differences [ Time Frame: 48 hours ]Reported differences in skin irritation or side-effects reported per patient questionnaire
- Differences between skin type groupings [ Time Frame: 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).
- Differences between age groups [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01257763
|United States, Illinois|
|Northwestern University Feinberg School of Medicine, Department of Dermatology|
|Chicago, Illinois, United States, 60611|
|Study Director:||Dennis P West, PhD||Northwestern University|
|Principal Investigator:||Murad Alam, MD||Northwestern University|