Tolerability Study of the Application of a 3M Microstructure Transdermal System
|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).
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|