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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03803059
Recruitment Status : Completed
First Posted : January 14, 2019
Last Update Posted : July 24, 2020
Sponsor:
Information provided by (Responsible Party):
Bellus Medical, LLC

Brief Summary:
This single-center, 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 fine lines and wrinkles of the face and neck.

Condition or disease Intervention/treatment Phase
Wrinkle Fine Lines Device: SkinPen Precision Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Center Trial to Evaluate the Efficacy and Tolerability of SkinPen on Male and Female Subjects' Fine Lines and Wrinkles of the Face and Neck
Actual Study Start Date : January 31, 2019
Actual Primary Completion Date : January 10, 2020
Actual Study Completion Date : January 10, 2020

Arm Intervention/treatment
Experimental: Fine lines and wrinkles
Microneedle treatment to face and neck areas.
Device: SkinPen Precision
Surgical instrument motors and accessories/attachments/Hydrogel




Primary Outcome Measures :
  1. Assessment of fine lines and wrinkles severity [ Time Frame: 6 months ]
    A modified Griffith's 10-point scale from 0 to 9. 0 indicates none (best possible condition), while 9 indicates severe (worst possible condition.)

  2. Assessment of fine lines and wrinkles severity [ Time Frame: 6 months ]
    The Fitzpatrick Wrinkle Classification System (FWCS) from 0 to 9. 0 indicates no fine lines or wrinkles, while 9 indicates significant (severe) fine lines or wrinkles observable.


Secondary Outcome Measures :
  1. Aesthetic improvement [ Time Frame: 6 months ]
    Global Aesthetic improvement assessment from 1 to 5. 1 indicates Very Much Improved: Optimal cosmetic result in this subject, while 5 indicates Worse: the appearance is worse than the original condition.

  2. Skin thickness [ Time Frame: 6 months ]
    OCT

  3. Skin density [ Time Frame: 6 months ]
    Ultrasound

  4. Skin firmness [ Time Frame: 6 months ]
    BTC 2000

  5. Integrity of the stratum corneum [ Time Frame: 6 months ]
    TEWL



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 fine lines and wrinkles
  • Individuals willing to withhold aesthetic therapies to the areas of the face and neck being treated or judged to potentially impact results by the Investigator.
  • 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 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 study;
    • Without a uterus and/or both ovaries;
    • Bilateral tubal ligation at least 6 months prior to study enrollment.
  • Individuals of child baring potential who use an acceptable method of contraception throughout the study. Acceptable methods of birth control include:

    1. Established use of hormonal methods of contraception (oral, injected, implanted, patch or vaginal ring).
    2. Barrier methods of contraception with spermicide: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
    3. Intrauterine device (IUD) or intrauterine system (IUS)
    4. Surgical sterilization (e.g., vasectomy that has been confirmed effective by sperm count check, tubal occlusion, hysterectomy, bilateral salpingectomy/oophorectomy)
    5. 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.
  • Individuals willing to sign a photography release.
  • Willingness to cooperate and participate by following study requirements (including those outlined in section 5.5) for the duration of the study and to report any changes in health status or medications, adverse event symptoms, or reactions immediately.

Exclusion Criteria:

  • Individuals diagnosed with known allergies to facial or general skin care products.
  • Individuals who have 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 whom 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.
  • 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;
    • Ablative resurfacing laser treatment;
    • Non-ablative, rejuvenative laser or light treatment within the past 6 months;
    • Surgical dermabrasion or deep facial peels;
    • Had a chemical peel, dermabrasion, non-ablative laser or fractional laser resurfacing of the face and neck within 4 weeks
  • Individuals with a history of using the following prescription medications:

    • Accutane or other systemic retinoids within the past 6 months;
    • Topical Retinoids within the past 2 weeks;
    • Prescription strength skin lightening devices (e.g. hydroquinone, tretinoin, AHA, BHA and polyhydroxy acids, 4-hydroxyanisole alone or in combination with tretinoin, etc.) within 4 months;
    • Any anti-wrinkle, skin lightening devices, or any other device or topical or systemic medication known to affect skin aging or dyschromia (devices containing alpha/beta/poly-hydroxy acids, vitamin C, soy, Q-10, hydroquinone; systemic or licorice extract (topically), Tego® Cosmo C250, gigawhite, lemon juice extract (topically), emblica extract, etc.) within 2 weeks;
    • Antiplatelet agents/Anticoagulants (Coumadin, Heparin, Plavix, chronic NSAID use); and/or
    • Psychiatric drugs that in the Investigator's opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.
  • Individuals who are nursing, pregnant, or planning to become pregnant during the study according to subject self-report.
  • Individuals having a health condition and/or pre-existing or dormant dermatologic disease on the face or body (e.g., psoriasis, rosacea, eczema, seborrheic dermatitis, vitiligo, hyper or hypo-skin pigmentation conditions such as post inflammatory hyperpigmentation) that the Investigator or designee deems inappropriate for participation or could interfere with the outcome of the study.
  • Individuals with a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.) and/or radiation as determined by study documentation.
  • Individuals with an uncontrolled disease such as asthma, diabetes, hyperthyroidism, medically significant hypertension or hypothyroidism. Individuals having multiple health conditions may be excluded from participation even if the conditions are controlled by diet, medication, etc.
  • Individuals with any planned surgeries, overnight hospitalization, and/or invasive medical procedures during the course of the study.
  • Individuals who are currently participating in any other study involving the use of investigational devices or drugs or have participated in any clinical trial at UT Southwestern or at another research facility or doctor's office within 4 weeks prior to inclusion into the study.
  • Individuals who have observable suntan, nevi, excessive hair, etc. or other dermal conditions on the face and neck that might influence the test results in the opinion of the Investigator or designee.
  • Individuals who have any condition, which in the opinion of the Investigator makes the patient unable to complete the study per protocol (e.g. patients not likely to avoid other facial cosmetic treatments; patients not likely to stay in the study for its duration because of other commitments, concomitant conditions, or past history; patients anticipated to be unreliable, or patients who have a concomitant condition that may develop symptoms that might confuse or confound study treatments or assessments).
  • Individuals who started hormone replacement therapies (HRT) or hormones for birth control less than 3 months prior to study entry or who plan on starting, stopping, or changing doses of HRT or hormones for birth control during the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803059


Locations
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United States, Texas
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-9132
Sponsors and Collaborators
Bellus Medical, LLC
Investigators
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Principal Investigator: Jeffrey Kenkel, MD University of Texas Southwestern Medical Center
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Responsible Party: Bellus Medical, LLC
ClinicalTrials.gov Identifier: NCT03803059    
Other Study ID Numbers: Bellmed002
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes