Status:
COMPLETED
Tolerability Study of the Application of a 3M Microstructure Transdermal System
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
3M
Conditions:
Healthy
Eligibility:
All Genders
18-74 years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01257763
Start Date
May 1 2010
End Date
April 1 2011
Last Update
December 2 2021
Active Locations (1)
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1
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611