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Combining Broad Based Light (BBL), Fractionated 1927 (MOXI) and Dual Wavelength 2940/1470 (HALO)

Primary Purpose

Pigment Skin

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sciton Joule System
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pigment Skin

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy male and female adults between 20-75 years of age Fitzpatrick skin type 1-4 Individual deemed by the Investigator to benefit from skin resurfacing treatment(s) Individuals willing to withhold aesthetic therapies that may potentially impact results to the treatment areas for the duration of the study Women of childbearing potential: 5.1. will be asked to agree to a pregnancy test before their screening visit in clinic 5.2. must use an acceptable method of birth control Hormonal contraception (oral, injected, implanted, patch or vaginal ring) Barrier method with spermicide: condom or occlusive cap with spermicidal foam/gel/cream/suppository Intrauterine device (IUD) Surgical Sterilization (e.gh., vasectomy, tubal occlusion, hysterectomy, bilateral salpingectomy/oophorectomy) Abstinence from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the subject. Periodical abstinence and withdrawal methods are not acceptable forms of contraception. Individuals who can read, speak, write and understand English and who are willing to provide written informed consent. Individuals willing to sign a photography release with the understanding that their photos may be used during presentations at national conferences and/or published in journals Individuals willing and able to cooperate with all study requirements for the duration of the study. Exclusion Criteria: Fitzpatrick skin type V-VI Known allergies to general skin care products Sensitivity to topical local anesthetic Current or recent history of skin diseases: • Systemic granulomatous disease, either active or inactive, (e.g., Sarcoid, Wegener's, TB, etc) or connective tissue diseases (e.g., lupus, dermatomyositis, etc.) Significant scars in the treatment area: Severe or cystic and clinically significant acne or acne scars on the areas to be treated Current or history of hypertrophic scarring or keloid scars Tattoos in the area to be treated Observable suntan, nevi, excessive hair, etc., or other dermal conditions that might influence study results on the face in the opinion of the Investigator Individuals who currently have cancerous or pre-cancerous lesions in the area to be treated Individuals with skin pathology and/or pre-existing dermatologic condition that the Investigator deems inappropriate for participation or could interfere with outcomes of the study, such as: psoriasis, rosacea, eczema, seborrheic dermatitis, vitiligo, etc. History of chronic drug or alcohol use Recent aesthetic treatments: <4 weeks of microdermabrasion or glycolic acid treatment to the treatment area or who plan to have this treatment during the study <2 weeks of any type of injectable filler <1 week of neurotoxin's <6 months of ablative resurfacing laser treatments <6 months of non-ablative, rejuvenative laser or light treatment <3 months of chemical peels or dermabrasion Use of the following prescription medications: <6 weeks of Accutane or other systemic retinoids on the treatment area <4 weeks of topical retinoids <4 months of prescription strength lightening medications (e.g., hydroquinone, tretinoin, AHA, BHA, poly-hydroxy acids, 4-hydroxyanisole alone or in combination with tretinoin) <2 weeks of anti-wrinkle or skin lightening or topical systemic medication known to affect skin aging or dyschromia (e.g., alpha/beta/polyhydroxy acids, Vitamin C, soy, Q-10; hydroquinone, etc.,), TEGO, Cosmo C250, gigawhite, lemon juice extract (topically), or embilica extract Antiplatelet agents/anticoagulant (Coumadin, Heparin, Plavix, chronic NSAID use) Psychiatric drugs that would impair the subject from understanding protocol requirements or understanding and signing the ICF. Individuals who are pregnant or planning to become pregnant during the course of the study Immunocompromised individuals or those currently using immunosuppressive medications and/or radiation Individuals with uncontrolled disease such as asthma, diabetes, hyperthyroidism, medically significant hypertension, or hypothyroidism. Individuals with any planned surgeries, overnight hospitalization, and/or invasive medical procedures planned during the course of the study. Individuals who, in the Investigator's opinion, have a history of poor cooperation, unreliability or noncompliance with medical treatment. Individuals who are unable to understand instructions or give informed consent Individuals who have physical or psychological conditions which, in the opinion of the Investigator, makes them unable to complete the study per protocol.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Single Treatment Arm

    Double Treatment Arm

    Arm Description

    Subjects will receive a single treatment of BBL/MOXI/HALO

    Subjects will receive double treatment of BBL/MOXI/HALO 4-6 weeks apart.

    Outcomes

    Primary Outcome Measures

    Change in VISIA Imaging System Analysis
    The VISIA Imaging System will be used to quantify data including spots, wrinkles, texture pores, UV spots, brown spots, red areas and porphyrins.

    Secondary Outcome Measures

    Monitor incidence, severity and relatedness of adverse events
    Study team will monitor adverse events throughout the study.

    Full Information

    First Posted
    October 13, 2023
    Last Updated
    October 19, 2023
    Sponsor
    University of Texas Southwestern Medical Center
    Collaborators
    Sciton
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06091215
    Brief Title
    Combining Broad Based Light (BBL), Fractionated 1927 (MOXI) and Dual Wavelength 2940/1470 (HALO)
    Official Title
    Combining Broad Based Light, Fractionated 1927 and Dual Wavelength 2940/1470 for Diffuse Pigmentation, Texture and Actinic Changes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 15, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Texas Southwestern Medical Center
    Collaborators
    Sciton

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a single-site, non-randomized, non-controlled study at UT Southwestern Medical Center at Dallas in the Department of Plastic Surgery. The study is designed to follow up to 15 consenting subjects who may receive up to 2 BBL/MOXI/HALO treatments under an IRB approved protocol.
    Detailed Description
    Subjects will receive 1-2 BBL/MOXI/HALO treatments. All 2nd treatments will be scheduled 4-8 weeks after the initial treatment to ensure the skin has enough time to recover. Overall assessments will be collected before the first treatment and at subsequent follow-up visits at 1 Month and 3 Months post final treatment. Identifiable full-face standard and close-up photography will be obtained and used to evaluate any changes. Subjects will also have photos obtained with the VISIA-CR Imaging System (Canfield Scientific, Parsippany, NJ). Quantitative analysis will be completed on the VISIA imaging system and be used to compare the effects of the treatments. Any improvements will be evaluated to pre-treatment assessments.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pigment Skin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Subjects will receive 1-2 combination treatments.
    Masking
    None (Open Label)
    Masking Description
    PI will assess subject after a single treatment and decide if a second treatment is necessary.
    Allocation
    Non-Randomized
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Single Treatment Arm
    Arm Type
    Active Comparator
    Arm Description
    Subjects will receive a single treatment of BBL/MOXI/HALO
    Arm Title
    Double Treatment Arm
    Arm Type
    Active Comparator
    Arm Description
    Subjects will receive double treatment of BBL/MOXI/HALO 4-6 weeks apart.
    Intervention Type
    Device
    Intervention Name(s)
    Sciton Joule System
    Intervention Description
    Sciton Joule System
    Primary Outcome Measure Information:
    Title
    Change in VISIA Imaging System Analysis
    Description
    The VISIA Imaging System will be used to quantify data including spots, wrinkles, texture pores, UV spots, brown spots, red areas and porphyrins.
    Time Frame
    Baseline, 1 Month and 3 Months
    Secondary Outcome Measure Information:
    Title
    Monitor incidence, severity and relatedness of adverse events
    Description
    Study team will monitor adverse events throughout the study.
    Time Frame
    Through study completion, an average of 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy male and female adults between 20-75 years of age Fitzpatrick skin type 1-4 Individual deemed by the Investigator to benefit from skin resurfacing treatment(s) Individuals willing to withhold aesthetic therapies that may potentially impact results to the treatment areas for the duration of the study Women of childbearing potential: 5.1. will be asked to agree to a pregnancy test before their screening visit in clinic 5.2. must use an acceptable method of birth control Hormonal contraception (oral, injected, implanted, patch or vaginal ring) Barrier method with spermicide: condom or occlusive cap with spermicidal foam/gel/cream/suppository Intrauterine device (IUD) Surgical Sterilization (e.gh., vasectomy, tubal occlusion, hysterectomy, bilateral salpingectomy/oophorectomy) Abstinence from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the subject. Periodical abstinence and withdrawal methods are not acceptable forms of contraception. Individuals who can read, speak, write and understand English and who are willing to provide written informed consent. Individuals willing to sign a photography release with the understanding that their photos may be used during presentations at national conferences and/or published in journals Individuals willing and able to cooperate with all study requirements for the duration of the study. Exclusion Criteria: Fitzpatrick skin type V-VI Known allergies to general skin care products Sensitivity to topical local anesthetic Current or recent history of skin diseases: • Systemic granulomatous disease, either active or inactive, (e.g., Sarcoid, Wegener's, TB, etc) or connective tissue diseases (e.g., lupus, dermatomyositis, etc.) Significant scars in the treatment area: Severe or cystic and clinically significant acne or acne scars on the areas to be treated Current or history of hypertrophic scarring or keloid scars Tattoos in the area to be treated Observable suntan, nevi, excessive hair, etc., or other dermal conditions that might influence study results on the face in the opinion of the Investigator Individuals who currently have cancerous or pre-cancerous lesions in the area to be treated Individuals with skin pathology and/or pre-existing dermatologic condition that the Investigator deems inappropriate for participation or could interfere with outcomes of the study, such as: psoriasis, rosacea, eczema, seborrheic dermatitis, vitiligo, etc. History of chronic drug or alcohol use Recent aesthetic treatments: <4 weeks of microdermabrasion or glycolic acid treatment to the treatment area or who plan to have this treatment during the study <2 weeks of any type of injectable filler <1 week of neurotoxin's <6 months of ablative resurfacing laser treatments <6 months of non-ablative, rejuvenative laser or light treatment <3 months of chemical peels or dermabrasion Use of the following prescription medications: <6 weeks of Accutane or other systemic retinoids on the treatment area <4 weeks of topical retinoids <4 months of prescription strength lightening medications (e.g., hydroquinone, tretinoin, AHA, BHA, poly-hydroxy acids, 4-hydroxyanisole alone or in combination with tretinoin) <2 weeks of anti-wrinkle or skin lightening or topical systemic medication known to affect skin aging or dyschromia (e.g., alpha/beta/polyhydroxy acids, Vitamin C, soy, Q-10; hydroquinone, etc.,), TEGO, Cosmo C250, gigawhite, lemon juice extract (topically), or embilica extract Antiplatelet agents/anticoagulant (Coumadin, Heparin, Plavix, chronic NSAID use) Psychiatric drugs that would impair the subject from understanding protocol requirements or understanding and signing the ICF. Individuals who are pregnant or planning to become pregnant during the course of the study Immunocompromised individuals or those currently using immunosuppressive medications and/or radiation Individuals with uncontrolled disease such as asthma, diabetes, hyperthyroidism, medically significant hypertension, or hypothyroidism. Individuals with any planned surgeries, overnight hospitalization, and/or invasive medical procedures planned during the course of the study. Individuals who, in the Investigator's opinion, have a history of poor cooperation, unreliability or noncompliance with medical treatment. Individuals who are unable to understand instructions or give informed consent Individuals who have physical or psychological conditions which, in the opinion of the Investigator, makes them unable to complete the study per protocol.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jennifer Barillas
    Phone
    214-645-8907
    Email
    jennifer.barillas@utsouthwestern.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Debby Noble
    Phone
    214-645-8686
    Email
    debby.noble@utsouthwestern.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jeffrey Kenkel, MD
    Organizational Affiliation
    UT Southwestern
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Combining Broad Based Light (BBL), Fractionated 1927 (MOXI) and Dual Wavelength 2940/1470 (HALO)

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