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

NCT ID: NCT01257763

Last Updated: 2021-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Transdermal Microchannel Skin System

Intervention Type: 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.

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.

Group Type: SHAM_COMPARATOR

Sham device

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

3M

INDUSTRY

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Murad Alam

Professor in Dermatology, Otolaryngology- Head and Neck Surgery, and Surgery-Organ Transplantation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dennis P West, PhD

Role: STUDY_DIRECTOR

Northwestern University

Murad Alam, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 22431712 (View on PubMed)

Other Identifiers

STU38370

Identifier Type: -

Identifier Source: org_study_id