A Proof of Concept Study to Evaluate the Efficacy and Tolerability of Skinpen on Male and Female Subjects' Dorsal Hands as a Treatment of Hand Aging

NCT05030051 | Completed FDA Device

• 1 other identifier: CL-HAS-21-03
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This proof of concept study is being conducted over the course of 60 days followed by a 3-month post-treatment visit to assess the efficacy and tolerability of the Sponsor's SkinPen device when used to treat men and women with signs of aging on the dorsum of the hands. Overall assessment of clinical outcome and safety will be based on the evaluation of pre-and post-treatment photos comparing baseline to final visit. The subject's assessment of satisfaction will also be evaluated at Visit 3 and Visit 4. Finally, both the clinician's and subject's assessments will be characterized using a clinician assessment scale at the 3-month post-treatment visit.

Conditions

Skin Aging

Outcome Measures

Primary Outcomes (1)

• Clinician's global aesthetic improvement assessment (CGAIS)

  This scale should be completed: • Based on a live assessment of the subject while referring to the subject's pre-treatment photographs of the dorsal hand and final visit Rating Description 1. Very Much Improved: Optimal cosmetic result in this subject. 2. Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject. 3. Improved: Obvious improvement in appearance from initial condition, but a re-treatment is indicated. 4. No Change: The appearance is essentially the same as the original condition. 5. Worse: The appearance is worse than the original condition.

  3-Month Post Treatment

Secondary Outcomes (1)

• Subject's global aesthetic improvement assessment (SGAIS)

  3-Month Post Treatment

Study Arms (1)

SkinPen Precision System

EXPERIMENTAL

This proof of concept study is being conducted over the course of 60 days followed by a 3-month post-treatment visit to assess the efficacy and tolerability of the Sponsor's SkinPen device when used to treat men and women with signs of aging on the dorsum of the hands. Overall assessment of clinical outcome and safety will be based on the evaluation of pre- and post-treatment photos comparing baseline to final visit. The subject's assessment of satisfaction will also be evaluated at Visit 3 and Visit 4. Finally, both the clinician's and subject's assessment will be characterized using a clinician assessment scale at the 3 month post-treatment visit.

Device: SkinPen Precision System

Interventions

SkinPen Precision System DEVICE

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 Crown Laboratories 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. We hypothesize that the SkinPen device will produce a significant improvement in dorsal hand appearance at 3 month post treatment visit, when compared with baseline scores. The assessments will be based on the Clinician's Global Aesthetic Improvement Scale, and the Subject's Global Aesthetic Improvement Scale at the 3 month post treatment visit.

SkinPen Precision System

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women 50 to 75 years of age in 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 childbearing 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 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.
• Individuals who, in the Investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.

Sponsors & Collaborators

• Crown Laboratories, Inc.: lead

Study Sites (1)

Crown Laboratories

Dallas, Texas, 75234, United States

Location

Study Design

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

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 1, 2021
• Study Start: March 12, 2021
• Primary Completion: June 30, 2022
• Study Completion: November 30, 2022
• Last Updated: December 18, 2023

Record last verified: 2023-12

Locations

US (1)