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

NCT06091215 | Completed Results FDA Device

• 1 other identifier: STU-2023-1040
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Pigment Skin

Outcome Measures

Primary Outcomes (32)

• Change in Brown Spots at 1 Month From Baseline (Single Treatment Group)

  Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement

  Baseline, 1 Month

• Change in Brown Spots at 3 Months From Baseline (Single Treatment Group)

  Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement

  Baseline, 3 Months

• Change in Brown Spots at 1 Month From Baseline (Double Treatment Group)

  Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement

  Baseline, 1 Month

• Change in Brown Spots at 3 Months From Baseline (Double Treatment Group)

  Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement

  Baseline, 3 Months

• Change in Pores at 1 Month From Baseline (Single Treatment Group)

  Quantitively assessment of change in overall pore count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.

  Baseline, 1 Month

• Change in Pores at 3 Months From Baseline (Single Treatment Group)

  Quantitively assessment of change in overall pore count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.

  Baseline, 3 Months

• Change in Pores at 1 Month From Baseline (Double Treatment Group)

  Quantitively assessment of change in overall pore count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement

  Baseline, 1 Month

• Change in Pores at 3 Months From Baseline (Double Treatment Group)

  Quantitively assessment of change in overall pore count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.

  Baseline, 3 Months

• Change in Porphyrins at 1 Month From Baseline (Single Treatment Group)

  Quantitively assessment of change in overall porphyrins count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.

  Baseline, 1 Month

• Change in Porphyrins at 3 Months From Baseline (Single Treatment Group)

  Quantitively assessment of change in overall porphyrins count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.

  Baseline, 3 Months

• Change in Porphyrins at 1 Month From Baseline (Double Treatment Group)

  Quantitively assessment of change in overall porphyrins count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.

  Baseline, 1 Month

• Change in Porphyrins at 3 Months From Baseline (Double Treatment Group)

  Quantitively assessment of change in overall porphyrins count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.

  Baseline, 3 Months

• Change in Red Features at 1 Month From Baseline (Single Treatment Group)

  Quantitively assessment of change in overall red features using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement

  Baseline, 1 Month

• Change in Red Features at 3 Months From Baseline (Single Treatment Group)

  Quantitively assessment of change in overall red features using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement

  Baseline, 3 Months

• Change in Red Features at 1 Month From Baseline (Double Treatment Group)

  Quantitively assessment of change in overall red features using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement

  Baseline, 1 Month

• Change in Red Features at 3 Months From Baseline (Double Treatment Group)

  Quantitively assessment of change in overall red features using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement

  Baseline, 3 Months

• Change in Texture at 1 Month From Baseline (Single Treatment Group)

  Quantitively assessment of change in overall texture using measurements provided VISIA 3D analysis on different sides of the face for all subjects. Skin analysis is performed by the system to generate a numerical roughness count by providing a tally of the feature. A lower value signifies improvement. Minimum and Maximum value does not exist. The value is an Absolute Score derived from the integration of multiple topographical variables; because it measures the intensity of texture rather than a specific length or depth, it has no standard metric unit

  Baseline, 1 Month

• Change in Texture at 3 Months From Baseline (Single Treatment Group)

  Quantitively assessment of change in overall texture using measurements provided VISIA 3D analysis on different sides of the face for all subjects. Skin analysis is performed by the system to generate a numerical roughness count by providing a tally of the feature. A lower value signifies improvement. Minimum and Maximum value does not exist. The value is an Absolute Score derived from the integration of multiple topographical variables; because it measures the intensity of texture rather than a specific length or depth, it has no standard metric unit

  Baseline, 3 Months

• Change in Texture at 1 Month From Baseline (Double Treatment Group)

  Quantitively assessment of change in overall texture using measurements provided VISIA 3D analysis on different sides of the face for all subjects. Skin analysis is performed by the system to generate a numerical roughness count by providing a tally of the feature. A lower value signifies improvement. Minimum and Maximum value does not exist. The value is an Absolute Score derived from the integration of multiple topographical variables; because it measures the intensity of texture rather than a specific length or depth, it has no standard metric unit

  Baseline, 1 Month

• Change in Texture at 3 Months From Baseline (Double Treatment Group)

  Quantitively assessment of change in overall texture using measurements provided VISIA 3D analysis on different sides of the face for all subjects. Skin analysis is performed by the system to generate a numerical roughness count by providing a tally of the feature. A lower value signifies improvement. Minimum and Maximum value does not exist. The value is an Absolute Score derived from the integration of multiple topographical variables; because it measures the intensity of texture rather than a specific length or depth, it has no standard metric unit

  Baseline, 3 Months

• Change in UV Spots at 1 Month From Baseline (Single Treatment Group)

  Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement

  Baseline, 1 Month

• Change in UV Spots at 3 Months From Baseline (Single Treatment Group)

  Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement

  Baseline, 3 Months

• Change in UV Spots at 1 Month From Baseline (Double Treatment Group)

  Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement

  Baseline, 1 Month

• Change in UV Spots at 3 Months From Baseline (Double Treatment Group)

  Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement

  Baseline, 3 Months

• Change in Visible Spots at 1 Month From Baseline (Single Treatment Group)

  Quantitively assessment of change in overall visible spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement

  Baseline, 1 Month

• Change in Visible Spots at 3 Months From Baseline (Single Treatment Group)

  Quantitively assessment of change in overall visible spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement

  Baseline, 3 Months

• Change in Visible Spots at 1 Month From Baseline (Double Treatment Group)

  Quantitively assessment of change in overall visible spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement

  Baseline, 1 Month

• Change in Visible Spots at 3 Months From Baseline (Double Treatment Group)

  Quantitively assessment of change in overall visible spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement

  Baseline, 3 Months

• Change in Total Wrinkle Area at 1 Month From Baseline (Single Treatment Group)

  Quantitively assessment of change in overall wrinkle are using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.

  Baseline, 1 Month

• Change in Total Wrinkle Area at 3 Months From Baseline (Single Treatment Group)

  Quantitively assessment of change in overall wrinkle are using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.

  Baseline, 3 Months

• Change in Total Wrinkle Area at 1 Month From Baseline (Double Treatment Group)

  Quantitively assessment of change in overall wrinkle are using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.

  Baseline, 1 Month

• Change in Total Wrinkle Area at 3 Months From Baseline (Double Treatment Group)

  Quantitively assessment of change in overall wrinkle are using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.

  Baseline, 3 Months

Study Arms (2)

Single Treatment Arm

ACTIVE COMPARATOR

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

Device: Sciton Joule System

Double Treatment Arm

ACTIVE COMPARATOR

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

Device: Sciton Joule System

Interventions

Sciton Joule System DEVICE

Sciton Joule System

Double Treatment Arm; Single Treatment Arm

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Sciton: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Pigmentation Disorders

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Lead Coordinator
• Organization: UT Southwestern

jennifer.barillas@utsouthwestern.edu

214-645-8907

Study Officials

• Jeffrey Kenkel, MD

  UT Southwestern

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: PI will assess subject after a single treatment and decide if a second treatment is necessary.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Subjects will receive 1-2 combination treatments.

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 19, 2023
• Study Start: January 1, 2024
• Primary Completion: June 11, 2024
• Study Completion: December 31, 2024
• Last Updated: January 27, 2026
• Results First Posted: January 27, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)