Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

December 8, 2010
September 14, 2012
May 2010
April 2011   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01257763 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
Not Provided
Not Provided
 
Tolerability Study of the Application of a 3M Microstructure Transdermal System
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Healthy
  • 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.
  • 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.
  • 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.
    Intervention: Device: Transdermal Microchannel Skin System
  • 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.
    Intervention: Device: Sham device
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 74 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01257763
STU38370
Yes
Murad Alam, Northwestern University
Northwestern University
3M
Study Director: Dennis P West, PhD Northwestern University
Principal Investigator: Murad Alam, MD Northwestern University
Northwestern University
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP