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

NCT01257763 | Completed Phase 1 DMC

• 1 other identifier: STU38370
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

needles/adverse effects; administration, cutaneous; erythema; pain measurement; Safety; Microstructure Transdermal System

Outcome Measures

Primary Outcomes (4)

• Local skin reaction scores

  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

  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

  Reported pain and change in skin irritation at the central forehead site.

  24 hours

• Local skin reaction score and reported pain chin

  Reported pain and change in skin irritation at the chin site.

  24 hours

Secondary Outcomes (4)

• Max difference in skin reaction score

  48 hours

• Subject questionnaire differences

  48 hours

• Differences between skin type groupings

  48 hours

• Differences between age groups

  48 hours

Study Arms (2)

Study device

EXPERIMENTAL

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

Sham device

SHAM COMPARATOR

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

Interventions

Transdermal Microchannel Skin System 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.

Study device

Sham device 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.

Sham device

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• 3M: collaborator

Study Sites (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• 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.

  PMID: 22431712 DERIVED

MeSH Terms

Conditions

Erythema

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dennis P West, PhD

  Northwestern University

  STUDY DIRECTOR

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Dermatology, Otolaryngology- Head and Neck Surgery, and Surgery-Organ Transplantation

Study Record Dates

• First Submitted: December 8, 2010
• First Posted: December 10, 2010
• Study Start: May 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: December 2, 2021

Record last verified: 2021-11

Locations

US (1)