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

Completed · Not applicable

Conditions studied: Skin Aging

In brief

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.

Key facts

Study ID

NCT05030051

Run by

Crown Laboratories, Inc.

People needed

18

Starts

2021-03-12

Expected to finish

2022-11-30

Last updated by the study team

2023-12-18

Who can join

Age: 50 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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
• Exclusion Criteria:
• 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.

Where it is running

• Crown Laboratories — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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