Clinical trial NCT06091215: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pigment Skin
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Sciton
First posted: 2023-10-19
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will receive 1-2 combination treatments.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Healthy male and female adults between 20-75 years of age
2. Fitzpatrick skin type 1-4
3. Individual deemed by the Investigator to benefit from skin resurfacing treatment(s)
4. Individuals willing to withhold aesthetic therapies that may potentially impact results to the treatment areas for the duration of the study
5. 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.
6. Individuals who can read, speak, write and understand English and who are willing to provide written informed consent.
7. 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
8. Individuals willing and able to cooperate with all study requirements for the duration of the study.

Exclusion Criteria:

1. Fitzpatrick skin type V-VI
2. Known allergies to general skin care products
3. Sensitivity to topical local anesthetic
4. 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.)
5. 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
6. Tattoos in the area to be treated
7. Observable suntan, nevi, excessive hair, etc., or other dermal conditions that might influence study results on the face in the opinion of the Investigator
8. Individuals who currently have cancerous or pre-cancerous lesions in the area to be treated
9. 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.
10. History of chronic drug or alcohol use
11. 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
12. 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.
13. Individuals who are pregnant or planning to become pregnant during the course of the study
14. Immunocompromised individuals or those currently using immunosuppressive medications and/or radiation
15. Individuals with uncontrolled disease such as asthma, diabetes, hyperthyroidism, medically significant hypertension, or hypothyroidism.
16. Individuals with any planned surgeries, overnight hospitalization, and/or invasive medical procedures planned during the course of the study.
17. Individuals who, in the Investigator's opinion, have a history of poor cooperation, unreliability or noncompliance with medical treatment.
18. Individuals who are unable to understand instructions or give informed consent
19. Individuals who have physical or psychological conditions which, in the opinion of the Investigator, makes them unable to complete the study per protocol.

Primary outcomes:
measure: Change in VISIA Imaging System Analysis
timeFrame: Baseline, 1 Month and 3 Months
Secondary outcomes:
measure: Monitor incidence, severity and relatedness of adverse events
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern
name: Jeffrey Kenkel, MD
role: PRINCIPAL_INVESTIGATOR
References: