A Proof of Concept Study to Evaluate the Efficacy and Tolerability of Microneedling With SkinPen in Female and Male Subjects With Facial Acne Vulgaris, Ages 18 Through 45

Completed · Not applicable

Conditions studied: Acne Vulgaris

In brief

This single-center, proof of concept trial is being conducted over the course of 42 days followed by a 2-month post-last treatment visit in order to assess the efficacy and tolerability of the Sponsor's SkinPen device in treating Acne Vulgaris on the face.

Key facts

Study ID: NCT05071274
Run by: Crown Laboratories, Inc.
People needed: 31
Starts: 2021-03-15
Expected to finish: 2022-03-18
Last updated by the study team: 2022-03-28

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Adult males and females, ages 18 through 45, at the time the ICF is signed.
Clinical diagnosis of Acne Vulgaris
Investigator's Global Assessment (IGA) Score 1,2 or 3
Individuals willing to withhold aesthetic therapies to the areas of the face 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, facials, laser treatments, and tightening treatments, etc.) for the duration of the study. Waxing and threading is allowed but not facial laser hair removal.
Women of childbearing potential agree to take a urine pregnancy test at the Baseline visit. 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.
Individuals of childbearing potential who use an acceptable method of contraception throughout the study. Acceptable methods of birth control include:
Established use of hormonal methods of contraception (oral, injected, implanted, patch or vaginal ring) at least 3 months prior to study enrollment;
Barrier methods of contraception with spermicide: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
Intrauterine device (IUD) or intrauterine system (IUS)
Surgical sterilization (e.g., vasectomy that has been confirmed effective by sperm count check, tubal occlusion, hysterectomy, bilateral salpingectomy/oophorectomy)
Abstinence from heterosexual intercourse, when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
Individuals that are willing to provide written informed consent and are able to read, speak, write and understand the informed consent document.
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.

You may not qualify if…

Individuals diagnosed with known allergies to facial or general skin care products.
Individuals who have presence of an active systemic or local skin disease, other than Acne Vulgaris, 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 face (< 6 months).
Individuals who have significant scarring, other than atrophic acne scars, in the area(s) to be treated.
IGA Score 0 or 4.
Individuals who have a recent or current history of inflammatory skin disease other than Acne Vulgaris, infection, cancerous/pre-cancerous lesion, unhealed wound in the proposed treatment areas. 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 1 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.
Individuals who are current smokers or have smoked in the last 5 years.
Individuals who have a history of the following cosmetic treatments in the area(s) to be treated:
Skin tightening procedure within the past year;
Injectable filler of any type within the past:
12 months for Hyaluronic acid fillers (e.g. Restylane)
12 months for Ca Hydroxyapatite fillers (e.g. Radiesse)
24 months for Poly-L-Lactic acid fillers (e.g. Sculptra)
Ever for permanent fillers (e.g. Silicone, ArteFill)
Neurotoxins within the past 3 months;

Where it is running

Crown Laboratories — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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