Clinical trial NCT04616898: Analysis of the Performance of 1060 nm Diode and Radio Frequency Prior to Abdominoplasty
Official title: Analysis of the Performance of 1060 nm Diode Laser and Radiofrequency Intended for Fat Reduction Prior to Abdominoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adipose Tissue Atrophy
Keywords: Adipose
Fat
Lead sponsor: Venus Concept
Sponsor class: INDUSTRY
Collaborators: name: University of Texas
First posted: 2020-11-05
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: For this study, there will be three treatment groups in total. Details of each treatment are depicted in the addendum below. Groups 1 (laser only- 6 visits) and 2 (laser plus radiofrequency- 4 visits) will each consist of one patient. Group 3 (multiple vs. single laser treatments - 5 visits) will consist of three patients.
Primary purpose: BASIC_SCIENCE

Brief summary: To evaluate the safety and efficacy of treatment with 1060nm diode laser and radio frequency to be analyzed through histological and molecular analysis.

Detailed description: The Primary Objectives of this protocol are to evaluate the safety and efficacy of treatment with 1060nm diode laser and radio frequency for use in aesthetic dermatological procedures requiring the ablation, excision, incision, or coagulation of soft tissue. Efficacy will be analyzed through histological and molecular analysis. Safety will be analyzed by monitoring the occurrence of any adverse events.

Eligibility criteria: Inclusion Criteria:

* Patients who are currently seeking abdominoplasty surgery and are consenting to their tissue that is being excised, to be tested
* Informed consent agreement signed by the subject.
* Fitzpatrick skin type I-V (Although the systems are cleared for all skin types I-VI, it is recommended to use the Matrix applicators on skin types I-V).
* Willingness to follow the treatment and follow-up schedule and the post-treatment care.
* For female candidates - post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence).

Exclusion Criteria:

* Pregnant and/or breastfeeding.
* Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
* Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) one week before and after the treatment session.
* Use of retinoids, antioxidants or therapeutic skin nourishing supplements at medicinal concentration within 2 months of treatment or during the study and oral retinoids within 6 months of the study.
* Having received treatment with light, RF or other devices in the treated area within 6 months of treatment or during the study.
* Having received collagen/fat injections or other methods of augmentation with injected or implanted material in the treated area within 9 months of treatment or during the study.
* Having received Botox in the treated area within 6 months of treatment or during the study.
* Having undergone any other surgery in the treated area within 6 months of treatment (or more if skin has not healed completely) or during the study.
* History of keloid scarring or of abnormal wound healing.
* Suffering from current or history of significant skin conditions in the treated area or inflammatory skin conditions, including, but not limited to: active acne, excessive skin dryness, psoriasis, eczema, rash, rosacea (particularly severe open wound stage), varicella scars, open lacerations or abrasions and active cold sores or herpes sores prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course.
* History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
* History of epidermal or dermal disorders (particularly if involving collagen or microvascularity).
* History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
* Suffering from hormonal imbalance, as per the Investigator's discretion.
* Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the subject's physician discretion).
* Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including actinic keratosis, presence of malignant or pre-malignant pigmented lesions.
* Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), or pertinent neurological disorders.
* Vascular lesion, tattoo or permanent make-up in the treated area.
* Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
* Participation in a study of another device or drug within three month prior to enrollment or during the study.
* As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Primary outcomes:
measure: Changes in elastin as determined by histology on biopsied tissues
timeFrame: Day 1, Day 7, Day 14, Day 20-30 post-treatment
measure: Changes in collagen as determined by histology on biopsied tissues
timeFrame: Day 1, Day 7, Day 14, Day 20-30 post-treatment
measure: Changes in hyaluronic acid as determined by histology on biopsied tissues
timeFrame: Day 1, Day 7, Day 14, Day 20-30 post-treatment
Secondary outcomes:
measure: Changes in elastin as a result of treatment measured by quantification of gene expression
timeFrame: Day 1, Day 7, Day 14, Day 20-30 post-treatment
measure: Changes in collagen as a result of treatment measured by quantification of gene expression
timeFrame: Day 1, Day 7, Day 14, Day 20-30 post-treatment
measure: Changes in hyaluronic acid as a result of treatment measured by quantification of gene expression
timeFrame: Day 1, Day 7, Day 14, Day 20-30 post-treatment
measure: Quantification of the immune response following treatment
timeFrame: Day 1, Day 7, Day 14, Day 20-30 post-treatment
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Dr. Brian Kinney Plastic Surgeon
state: California
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
Study officials:
affiliation: University of Texas
name: Jeffrey Kenkel, MD
role: PRINCIPAL_INVESTIGATOR
References: