Efficacy and Tolerability of SkinPen on Male and Female Subjects' Wrinkles of the Neck

NCT03803059 | Completed Results FDA Device

• 1 other identifier: Bellmed002
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center, the clinical trial is being conducted over the course of 90 days followed by 1-month and 6-month post-treatment visits in order to assess the efficacy and tolerability of the Sponsor's SkinPen device when used by men and women with the wrinkles of the neck.

Conditions

Wrinkles

Outcome Measures

Primary Outcomes (2)

• Assessment of Wrinkle Severity Using the Lemperle Wrinkle Assessment Scale

  Wrinkling in the neck region will be assessed according to the following definitions: Class 0: No Wrinkles Class 1: Just perceptible wrinkle Class 2: Shallow wrinkles Class 3: Moderately deep wrinkle Class 4: Deep wrinkle, well-defined edges Class 5: Very deep wrinkle, redundant fold

  Day 1 and 3 Month Post Treatment

• Clinician's Global Aesthetic Improvement Assessment (CGAIS)

  This scale is completed in two steps: * Based on a live assessment of the subject while referring to the subject's pre-treatment photographs of the neck, and * Based on a comparison of the subject's pre-treatment photographs to the current post-treatment photographs of the neck. Rating and its 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 the initial condition, but 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 (10)

• Subject Global Aesthetic Improvement Scale (SGAIS)

  1 Month Post Treatment and 3 Month Post Treatment

• Transepidermal Water Loss of the Left Neck by Biox Aquaflux

  Baseline, 3 Months post treatment

• Vascular Density Measurements by Optical Coherence Tomography(OCT)

  Baseline (Day 1) and 3-Month post Treatment

• Skin Roughness Measurements by Optical Coherence Tomography(OCT)

  Baseline (Day 1) and 3 Months post treatment

• BTC 2000 Measurements- Energy Absorption

  Baseline (Day 1) and 3 month post treatment

Study Arms (1)

Wrinkles of the Neck

EXPERIMENTAL

Microneedle treatment neck areas.

Device: SkinPen Precision

Interventions

SkinPen Precision DEVICE

Surgical instrument motors and accessories/attachments/Hydrogel

Wrinkles of the Neck

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 20% of subjects will have Fitzpatrick skin types IV-VI Individuals who grade a 4 or higher on the Fitzpatrick Wrinkle Scale Individuals that desire correction of their wrinkles Individuals willing to withhold aesthetic therapies to the areas of the neck being treated or judged to potentially impact results by the Investigator.
• Women of childbearing potential agree to take a urine pregnancy test at the Baseline visit and 6-months post-treatment or when deemed by Investigator and/or Sponsor. This may be changed to one 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 the study;
• Without a uterus and/or both ovaries;
• Bilateral tubal ligation at least 6 months prior to study enrollment. Women of child bearing potential agree to take a urine pregnancy test at the Baseline visit and 6-months post-treatment or when deemed by Investigator and/or Sponsor. This may be changed to one month 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 the study;
• Without a uterus and/or both ovaries;
• Bilateral tubal ligation at least 6 months prior to study enrollment.
• Individuals of child-bearing 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).
• 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 English.

You may not qualify if:

• Individuals diagnosed with known allergies to facial or general skincare products.
• Individuals who have the 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, other than acne scars, in the area(s) to be treated.
• Individuals who have severe or cystic active and clinically significant acne on the area(s) to be treated. Clinically significant acne is defined as a subject who has \> 5 active inflammatory acne lesions (including acne conglobate, nodules, or cysts) in either the right or left treatment area.
• Individuals who have a recent or current history of inflammatory skin disease, infection, cancerous/pre-cancerous lesion, unhealed wound or clinically significant acne 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

• Bellus Medical, LLC: lead

Study Sites (1)

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390-9132, United States

Location

Related Publications (1)

• Alqam M, Wamsley CE, Hitchcock TM, Jones BC, Akgul Y, Kenkel JM. Efficacy and tolerability of a microneedling device for treating wrinkles on the face. J Cosmet Dermatol. 2023 Jan;22(1):206-213. doi: 10.1111/jocd.14985. Epub 2022 Jun 2.

  PMID: 35403786 DERIVED

Results Point of Contact

• Title: Thomas Hitchcock, PhD.
• Organization: Crown Laboratories, Inc

THitchcock@crownlaboratories.com

8883723982

Study Officials

• Jeffrey Kenkel, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: January 9, 2019
• First Posted: January 14, 2019
• Study Start: January 31, 2019
• Primary Completion: January 10, 2020
• Study Completion: January 10, 2020
• Last Updated: December 1, 2021
• Results First Posted: December 1, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)