Tolerability Study of the Application of a 3M Microstructure Transdermal System

This study has been completed.
Sponsor:
Collaborator:
3M
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT01257763
First received: December 8, 2010
Last updated: September 14, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Healthy
Device: Transdermal Microchannel Skin System
Device: Sham device
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Local skin reaction scores [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Reported pain and change in skin irritation at the central forehead site.

  • Local skin reaction score and reported pain chin [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Reported pain and change in skin irritation at the chin site.


Secondary Outcome Measures:
  • Max difference in skin reaction score [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    Maximal difference in local skin reaction score at any follow-up visit

  • Subject questionnaire differences [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    Reported differences in skin irritation or side-effects reported per patient questionnaire

  • Differences between skin type groupings [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 54
Study Start Date: May 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01257763

Locations
United States, Illinois
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
3M
Investigators
Study Director: Dennis P West, PhD Northwestern University
Principal Investigator: Murad Alam, MD Northwestern University
  More Information

No publications provided by Northwestern University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology- Head and Neck Surgery, and Surgery-Organ Transplantation, Northwestern University
ClinicalTrials.gov Identifier: NCT01257763     History of Changes
Other Study ID Numbers: STU38370
Study First Received: December 8, 2010
Last Updated: September 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
needles/adverse effects
administration, cutaneous
erythema
pain measurement
Safety
Microstructure Transdermal System

ClinicalTrials.gov processed this record on October 23, 2014