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

NCT05071274 | Completed FDA Device

• 1 other identifier: CL-AC-21-02
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Inflammatory and Non inflammatory Lesion count

  The primary endpoint of the study is reduction of lesion count from Visit 1 (baseline) to Visit 5, in the inflammatory (papules and pustules) and non-inflammatory (open and closed comedones) lesions.

  Through the course of the study, 120 days

Secondary Outcomes (1)

• Investigators Global Assessment (IGA)

  Through the course of the study, 120 days

Study Arms (1)

SkinPen Precision System

EXPERIMENTAL

After a 15-minute acclimation to ambient temperature and humidity conditions, subjects will participate in bio instrumentation to assess for erythema and will participate in standard photography. The Investigator will treat each subject's face from hairline to jawline with the SkinPen Precision System following instructions in the SKINPEN PRECISION SYSTEM INSTRUCTIONS with the following treatment of the face at depths of up to 1.5mm. Treatment depth will be recorded for each subject at every visit. Subjects will be dispensed a study provided diary and trained on compliance.

Device: Skinpen Prescision System

Interventions

Skinpen Prescision System DEVICE

Skinpen Precision is an automated nonsurgical micro needling device designed for use by licensed health care practitioners or individuals directed by practitioners. The device incorporates a sterile Microneedle cartridge and Biosheath for single use only.

SkinPen Precision System

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

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.

Sponsors & Collaborators

• Crown Laboratories, Inc.: lead

Study Sites (1)

Crown Laboratories

Dallas, Texas, 75234, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

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: This proof of Concept study serves to evaluate the efficacy and tolerability of Microneedling with SkinPen in female and male Subjects with facial Acne Vulgaris, ages 18 through 45. Overall assessment of clinical outcome and safety will be based on clinic visits. The Investigator will apply an objective and precise assessment, the Lesion Count of inflammatory and non-inflammatory lesions. The Investigator will also perform the IGA assessment. Subjects will be dispensed a Diary to record any new Adverse Events between visits. Subjects will be encouraged to contact the Study Investigator if any adverse events arise.

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 8, 2021
• Study Start: March 15, 2021
• Primary Completion: March 18, 2022
• Study Completion: March 18, 2022
• Last Updated: March 28, 2022

Record last verified: 2022-03

Locations

US (1)