Clinical trial NCT01257763: Tolerability Study of the Application of a 3M Microstructure Transdermal System
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: needles/adverse effects
administration, cutaneous
erythema
pain measurement
Safety
Microstructure Transdermal System
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: 3M
First posted: 2010-12-10
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Local skin reaction scores
timeFrame: 48 hours
measure: Median pain scores
timeFrame: 5 minutes
measure: Local skin reaction and reported pain central forehead
timeFrame: 24 hours
measure: Local skin reaction score and reported pain chin
timeFrame: 24 hours
Secondary outcomes:
measure: Max difference in skin reaction score
timeFrame: 48 hours
measure: Subject questionnaire differences
timeFrame: 48 hours
measure: Differences between skin type groupings
timeFrame: 48 hours
measure: Differences between age groups
timeFrame: 48 hours
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine, Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Dennis P West, PhD
role: STUDY_DIRECTOR
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.