- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01257763
Tolerability Study of the Application of a 3M Microstructure Transdermal System
November 30, 2021 updated by: Murad Alam, Northwestern University
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University Feinberg School of Medicine, Department of Dermatology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
The side not receiving application of the study device at each anatomical location will receive a comparable number of applications of a sham device.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
48 hours
|
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.
|
5 minutes
|
Local skin reaction and reported pain central forehead
Time Frame: 24 hours
|
Reported pain and change in skin irritation at the central forehead site.
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24 hours
|
Local skin reaction score and reported pain chin
Time Frame: 24 hours
|
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
Time Frame: 48 hours
|
Maximal difference in local skin reaction score at any follow-up visit
|
48 hours
|
Subject questionnaire differences
Time Frame: 48 hours
|
Reported differences in skin irritation or side-effects reported per patient questionnaire
|
48 hours
|
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).
|
48 hours
|
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).
|
48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Dennis P West, PhD, Northwestern University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
December 8, 2010
First Submitted That Met QC Criteria
December 9, 2010
First Posted (Estimate)
December 10, 2010
Study Record Updates
Last Update Posted (Actual)
December 2, 2021
Last Update Submitted That Met QC Criteria
November 30, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STU38370
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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