Study to Evaluate the Efficacy and Tolerability of the SkinPen on Male and Female Subjects' Dorsal Hands as a Treatment for Signs of Hand Aging

NCT04136847 | Withdrawn FDA Device

• 1 other identifier: Bellmed003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Microneedling is a relatively new, minimally invasive technique originally developed for skin rejuvenation. Controlled micro-injury to the dermis via the application of several small needles connected to a motorized device stimulates the wound healing process, resulting in the formation of new tissue and blood vessels. The SkinPen by Bellus Medical is an FDA-cleared microneedling device proven to improve the appearance of acne scars This study evaluates the clinical performance of the SkinPen device for the treatment of signs of aging on the back of the hand.

Conditions

Aging

Keywords

Signs of Hand Aging

Outcome Measures

Primary Outcomes (2)

• Aesthetic Assessment of change

  Clinician's global aesthetic improvement assessment (CGAIS) , a 5 point grading scale where 1 is ''Very Much Improved'' and 5 is ''Worse''

  6 months

• Aesthetic Assessment

  Subject's global aesthetic improvement assessment (CGAIS) , a 5 point grading scale where 1 is ''Very Much Improved'' and 5 is ''Worse''

  6 months

Secondary Outcomes (5)

• Adverse Events

  6 months

• Skin density

  6 months

• Skin Firmness

  6 months

• Assessments of aging signs

  6 months

• Treatment satisfaction assessment

  6 months

Study Arms (1)

Hand Aging

EXPERIMENTAL

Microneedling treatment of the dorsum of the hands

Device: SkinPen Precision

Interventions

SkinPen Precision DEVICE

Surgical instrument motors and accessories/attachments/Hydrogel

Hand Aging

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women 50 to 75 years of age having general good health.
• Individuals deemed by the Investigator, visually, to have signs of hand aging (presence of skin laxity, age spots, trophic changes) on the dorsum of the hand.. Also, Subjects would have to be willing to undergo correction of these signs of aging.
• Individuals willing to withhold aesthetic therapies to the areas of the hand being treated or judged to potentially impact results by the Investigator (e.g. soft tissue fillers and/or any resurfacing procedures, botulinum toxin, injectable fillers, microdermabrasion, IPL (intense pulsed light), peels, laser treatments, and tightening treatments, etc.) for the duration of the study. Waxing and threading is allowed but not laser hair removal.
• Individuals that are willing to provide written informed consent
• Individuals willing to sign a photography release.
• Willingness to cooperate and participate by following study requirements for the duration of the study and to report any changes in health status or medications, adverse event symptoms, or reactions immediately.
• Women of child bearing potential agree to take a urine pregnancy test at the Baseline visit and 3-months post-treatment or when deemed by Investigator and/or Sponsor. This may be changed to a monthly pregnancy test at the Sponsor's discretion. Women who are of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the baseline visit. Women must be willing and able to use an acceptable method of birth control (e.g. barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history:
• Postmenopausal for at least 12 months prior to study;
• Without a uterus and/or both ovaries;
• Bilateral tubal ligation at least 6 months prior to study enrollment.

You may not qualify if:

• Individuals diagnosed with known allergies to general skin care products.
• Individuals who have presence of an active systemic or local skin disease that may affect wound healing.
• Individuals who have severe solar elastosis.
• Individuals with sensitivity to topical lidocaine.
• Individuals who have physical or psychological conditions unacceptable to the Investigator.
• Individuals who have a recent history of significant trauma to the areas to be treated (\< 6 months).
• Individuals who have significant scarring in the area(s) to be treated.
• Individuals who have a recent or current history of inflammatory skin disease, infection or unhealed wound.
• Individuals who have a history of systemic granulomatous diseases, active or inactive, (e.g. Sarcoid, Wegeners, TB, etc.) or connective tissue diseases (e.g. lupus, dermatomyositis, etc.).
• Individuals who currently have or have a history of hypertrophic scars, or keloid scars.
• Individuals who currently have cancerous or pre-cancerous lesions in the areas to be treated and/or with a history of skin cancer.
• Individuals who have the inability to understand instructions or to give informed consent.
• Individuals who have had microdermabrasion or glycolic acid treatment to the treatment area(s) within one month prior to study participation or who will have this treatment during the study.
• Individuals who have a history of chronic drug or alcohol abuse.
• Individuals undergoing concurrent therapy that, in the Investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.

Sponsors & Collaborators

• Bellus Medical, LLC: lead

Study Sites (1)

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390-9132, United States

Location

Study Officials

• Jeffrey Kenkel, MD

  UTSW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: At least twenty three (23) qualified and consenting subjects treated with 4 Skinpen microneedling treatments.

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: October 23, 2019
• Study Start: January 10, 2020
• Primary Completion: May 26, 2020
• Study Completion: May 26, 2020
• Last Updated: June 7, 2021

Record last verified: 2021-06

Locations

US (1)