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Clinical Assessment of Skin Tightening and Contour Change of Submental Tissue Using Bipolar Radiofrequency Microneedling

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ClinicalTrials.gov Identifier: NCT04477187
Recruitment Status : Enrolling by invitation
First Posted : July 20, 2020
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
Jeffrey M. Kenkel, University of Texas Southwestern Medical Center

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of bipolar fractional radiofrequency treatment via use of the Profound System to achieve skin tightening and contour change in lax submental (beneath the chin) tissue.

Condition or disease Intervention/treatment Phase
Skin Laxity Device: Dermal Handpiece Not Applicable

Detailed Description:
This is a single-center, unblinded, non-randomized, non-controlled study designed to follow a total of up to 15 qualified and consenting subjects to receive one bipolar fractional radiofrequency microneedling treatment under an IRB approved protocol. Up to 15 subjects will be enrolled and treated at UT Southwestern in the Department of Plastic Surgery. Subjects will be identified from the clinical practice of Dr. Jeffrey Kenkel, Department of Plastic Surgery.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Assessment of Skin Tightening and Contour Change of Submental Tissue Using Bipolar Radiofrequency Microneedling
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single Group
All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece.
Device: Dermal Handpiece
Radiofrequency (RF) will travel through the RF generator through the electrodes and into the dermal layer beneath the surface of the skin. The microneedles of the dermal cartridges coupled with the thermal heat will stimulate neocollagenesis and neoelastosis, aiding in the reduction of submental laxity.




Primary Outcome Measures :
  1. Volume change in the submental region [ Time Frame: Baseline - 6 Months (Day 180) ]
    Improvement will be assessed by change in the surface area assessments of baseline (pre-procedure) and 6 months (post-procedure).

  2. Incidence, severity, and relatedness of adverse events [ Time Frame: Baseline - 6 Months (Day 180) ]
    The number and level of severity of adverse events after treatment. An assessment will be made by the PI to determine if the adverse event is related to the study device and/or procedure.


Secondary Outcome Measures :
  1. Improvement in overall lift: H2 and Stand Up Vectra [ Time Frame: Baseline - 6 Months (Day 180) ]
    Blinded evaluators will be asked to evaluate photographs obtained via the H2 3D Imaging System and Stand Up Vectra (Canfield) of the subjects at baseline (pre-treatment) and 6 months (post-treatment).

  2. Improvement in Assessments: Global Aesthetic Improvement Score [ Time Frame: Baseline - 6 Months (Day 180) ]
    Blinded reviewers will assessment and score using a 5-point Global Aesthetic Improvement Score (1=Very Much Improved, 5= worse)

  3. Subjects Assessment of Pain: Numerical Pain Rating Scale [ Time Frame: Through study completion, an average of 6 Months (Day 180) ]
    The subjects' assessment of pain will be completed using an 11-point Numerical Pain Scale (0= No pain, 10= Extreme pain)

  4. Improvement in Non-invasive Measurements: Aquaflux [ Time Frame: Baseline - 6 Months (Day 180) ]

    Skin texture and laxity will be assessed using non invasive skin measurements.

    Biox Aquaflux- will be used to measure transepidermal water loss.


  5. Improvement in Non-invasive Measurements: OCT [ Time Frame: Baseline - 6 Months (Day 180) ]

    Skin texture and laxity will be assessed using non invasive skin measurements.

    Optical coherence tomography will be used to topographical and histological images of the skin.


  6. Improvement in Non-invasive Measurements : BTC2000 [ Time Frame: Baseline - 6 Months (Day 180) ]

    Skin texture and laxity will be assessed using non invasive skin measurements.

    BTC2000- will be used to measure skin laxity values of the skin.


  7. Improvement in Non-invasive Measurements : BTC2000 [ Time Frame: Baseline - 6 Months (Day 180) ]

    Skin texture and laxity will be assessed using non invasive skin measurements.

    BTC2000- will be used to measure elasticity of the skin.




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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female adults between ages 21-70 years of age.
  • Desire skin laxity lift of the submental region.
  • Confirmed BMI ≤ 35.
  • Subjects who can read, understand, and sign the Informed Consent Form.
  • Subjects willing and able to comply with all study requirements.
  • Fitzpatrick skin type I-VI.
  • Submental fat graded by the Investigator as ≥ 1 using the Clinician-Reported Submental Fat Rating Scale
  • Subject is willing not to undergo any type of aesthetic procedure that could confound the study device treatment effects until he/she completes the study.

Exclusion Criteria:

  • Active localized or systemic infections, that may alter wound healing.
  • Immunocompromised subjects.
  • Subjects with coagulation disorder.
  • History of skin photosensitivity disorders, or use of photosensitizing drugs (e.g., tetracycline or sulfa drugs).
  • Pregnant and/or lactating (All female volunteers will be advised about using birth control during the period of study).
  • Excessive skin laxity on the submental and neck (Submental Skin Laxity Grade: SMSLG 4, Appendix E), or other anatomical feature for which reduction in SMF which may, in the judgment of the investigator, result in an aesthetically unacceptable outcome.
  • Scarring in areas to be treated.
  • Tattoos in the treatment areas to be treated.
  • Significant open facial wounds or lesions.
  • Severe or cystic acne in treatment areas.
  • Current active smoker.
  • Use of Accutane (Isotretinoin) within the past 6 months.
  • Use of topical retinoids within 48 hours.
  • Use of prescription anticoagulants.
  • Pacemaker or internal defibrillator.
  • History of skin disorders resulting in abnormal wound healing (i.e. keloids, extreme dry and fragile skin).
  • Subjects on current oral corticosteroid therapy or within the past 6 months
  • Metal implants in the treatment area.
  • In the opinion of the investigator, subject is unwilling or unable to adhere to all study requirements, including application and follow-up visits.
  • Subjects with a history of radiation therapy to the treatment area.
  • Subject has a history of allergy to lidocaine or ester-based local anesthetics.
  • Subjects with significant cardiac history or rhythm disturbance who may be unable to tolerate lidocaine with epinephrine.
  • Subjects with any skin pathology or condition in the treatment area that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during or after treatments (e.g. psoriasis, rosacea, eczema, seborrheic dermatitis, vitiligo, hyper or hypo-skin pigmentation conditions such as post inflammatory hyperpigmentation).
  • Subjects who are unwilling to shave excessive hair in the treatment area that might influence or impair evaluation in the opinion of the Investigator.
  • Subjects have undergone skin resurfacing or tightening treatments in the treatment area over the past year.
  • Subjects have undergone dermatological treatments such as fillers and neurotoxins for the past 6 months in the treatment area.
  • Subjects have undergone laser and light treatments in the treatment area over the past 3 months.
  • Subjects have undergone superficial peel or microdermabrasion within 4 weeks.

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): NCT04477187


Locations
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United States, Texas
UT Southwestern Medical Center- Dept of Plastic Surgery
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Jeffrey Kenkel, MD UT Southwestern
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Responsible Party: Jeffrey M. Kenkel, Professor and Chair Department of Plastic Surgery, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04477187    
Other Study ID Numbers: STU-2020-0593
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020

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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.: No
Additional relevant MeSH terms:
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Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases