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CompletedNCT06091215Updated Jan 27, 2026Results posted

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

An interventional study of Sciton Joule System in Pigment Skin, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-27.

Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Non-randomized
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pigment Skin

Browse trials for

03

In context

Pigmentation Disorders

44 studies on the registry are indexed under Pigmentation Disorders; 11 are open to participants now.

This study's enrollment of 15 is below the median of 32 across 33 interventional studies indexed under Pigmentation Disorders.

Browse Pigmentation Disorders studies →

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Active comparator
    Single Treatment Arm

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

    Device: Sciton Joule System

  • Active comparator
    Double Treatment Arm

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

    Device: Sciton Joule System

Interventions

  • DeviceSciton Joule System

    Sciton Joule System

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline, 1 Month

  2. 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

    Time frame: Baseline, 3 Months

  3. 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

    Time frame: Baseline, 1 Month

  4. 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

    Time frame: Baseline, 3 Months

  5. 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.

    Time frame: Baseline, 1 Month

  6. 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.

    Time frame: Baseline, 3 Months

  7. 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

    Time frame: Baseline, 1 Month

  8. 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.

    Time frame: Baseline, 3 Months

  9. 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.

    Time frame: Baseline, 1 Month

  10. 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.

    Time frame: Baseline, 3 Months

  11. 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.

    Time frame: Baseline, 1 Month

  12. 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.

    Time frame: Baseline, 3 Months

  13. 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

    Time frame: Baseline, 1 Month

  14. 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

    Time frame: Baseline, 3 Months

  15. 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

    Time frame: Baseline, 1 Month

  16. 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

    Time frame: Baseline, 3 Months

  17. 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

    Time frame: Baseline, 1 Month

  18. 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

    Time frame: Baseline, 3 Months

  19. 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

    Time frame: Baseline, 1 Month

  20. 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

    Time frame: Baseline, 3 Months

  21. 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

    Time frame: Baseline, 1 Month

  22. 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

    Time frame: Baseline, 3 Months

  23. 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

    Time frame: Baseline, 1 Month

  24. 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

    Time frame: Baseline, 3 Months

  25. 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

    Time frame: Baseline, 1 Month

  26. 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

    Time frame: Baseline, 3 Months

  27. 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

    Time frame: Baseline, 1 Month

  28. 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

    Time frame: Baseline, 3 Months

  29. 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.

    Time frame: Baseline, 1 Month

  30. 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.

    Time frame: Baseline, 3 Months

  31. 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.

    Time frame: Baseline, 1 Month

  32. 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.

    Time frame: Baseline, 3 Months

07

Results

Posted Jan 27, 2026

Participant flow

Single treatment (4 weeks)
Participant flow — Single treatment (4 weeks)
MilestoneHealthy Participants- Single Treatment GroupHealthy Participants- Double Treatment Group
Started78
Completed78
Not completed00
Double treatment (8 weeks)
Participant flow — Double treatment (8 weeks)
MilestoneHealthy Participants- Single Treatment GroupHealthy Participants- Double Treatment Group
Started08
Completed08
Not completed00

Outcome measures

PrimaryChange 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

Time frame:
Baseline, 1 Month
Reported as:
Median · count of spots
Change in Brown Spots at 1 Month From Baseline (Single Treatment Group)
count of spotsSingle Treatment Arm
Front12.00 (-2.00 to 17.00)
Left Oblique5.00 (-11.00 to 7.00)
Nose0.00 (-3.00 to 1.00)
Right Oblique5.00 (-11.00 to 5.00)
PrimaryChange 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

Time frame:
Baseline, 3 Months
Reported as:
Median · count of spots
Change in Brown Spots at 3 Months From Baseline (Single Treatment Group)
count of spotsSingle Treatment Arm
Front8.00 (6.00 to 12.00)
Left Oblique.00 (-2.00 to 25.00)
Nose3.00 (-1.00 to 5.00)
Right Oblique9.00 (-2.00 to 25.00)
PrimaryChange 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

Time frame:
Baseline, 1 Month
Reported as:
Median · count of spots
Change in Brown Spots at 1 Month From Baseline (Double Treatment Group)
count of spotsDouble Treatment Arm
Front-2.00 (-14.00 to 0.50)
Left Oblique-3.50 (-9.00 to -0.50)
Nose-2.00 (-4.50 to -0.50)
Right Oblique-2.50 (-16.50 to 12.50)
PrimaryChange 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

Time frame:
Baseline, 3 Months
Reported as:
Median · count of spots
Change in Brown Spots at 3 Months From Baseline (Double Treatment Group)
count of spotsDouble Treatment Arm
Front-0.50 (-12.00 to 9.00)
Left Oblique-4.00 (-9.50 to 6.50)
Nose-0.50 (-3.50 to 1.50)
Right Oblique8.50 (-14.00 to 22.50)
PrimaryChange 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.

Time frame:
Baseline, 1 Month
Reported as:
Median · count of pores
Change in Pores at 1 Month From Baseline (Single Treatment Group)
count of poresSingle Treatment Arm
Front-5.00 (-11.00 to 10.00)
Left Oblique-5.00 (-13.00 to 17.00)
Nose-11.00 (-21.00 to 3.00)
Right Oblique-3.00 (-7.00 to 10.00)
PrimaryChange 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.

Time frame:
Baseline, 3 Months
Reported as:
Median · count of pores
Change in Pores at 3 Months From Baseline (Single Treatment Group)
count of poresSingle Treatment Arm
Front1.00 (-34.00 to 14.00)
Left Oblique-1.00 (-6.00 to 17.00)
Nose1.00 (-15.00 to 5.00)
Right Oblique-7.00 (-21.00 to 3.00)
PrimaryChange 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

Time frame:
Baseline, 1 Month
Reported as:
Median · count of pores
Change in Pores at 1 Month From Baseline (Double Treatment Group)
count of poresDouble Treatment Arm
Front2.50 (-41.00 to 23.50)
Left Oblique-27.50 (-72.00 to 10.00)
Nose-10.00 (-28.00 to -5.50)
Right Oblique-17.00 (-60.00 to 34.00)
PrimaryChange 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.

Time frame:
Baseline, 3 Months
Reported as:
Median · count of pores
Change in Pores at 3 Months From Baseline (Double Treatment Group)
count of poresDouble Treatment Arm
Front-0.00 (-0.00 to -0.00)
Left Oblique-0.00 (-0.00 to 0.00)
Nose-0.00 (-0.01 to 0.00)
Right Oblique-0.00 (-0.00 to 0.00)
PrimaryChange 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.

Time frame:
Baseline, 1 Month
Reported as:
Median · count of porphyrins
Change in Porphyrins at 1 Month From Baseline (Single Treatment Group)
count of porphyrinsSingle Treatment Arm
Front17.00 (-292.00 to 217.00)
Left Oblique51.00 (-381.00 to 331.00)
Nose15.00 (-49.00 to 66.00)
Right Oblique4.00 (-290.00 to 351.00)
PrimaryChange 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.

Time frame:
Baseline, 3 Months
Reported as:
Median · count of porphyrins
Change in Porphyrins at 3 Months From Baseline (Single Treatment Group)
count of porphyrinsSingle Treatment Arm
Front-123.00 (-365.00 to 272.00)
Left Oblique-192.00 (-446.00 to 99.00)
Nose32.00 (-19.00 to 88.00)
Right Oblique-114.00 (-420.00 to 136.00)
PrimaryChange 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.

Time frame:
Baseline, 1 Month
Reported as:
Median · count of porphyrins
Change in Porphyrins at 1 Month From Baseline (Double Treatment Group)
count of porphyrinsDouble Treatment Arm
Front1.00 (-312.00 to 395.50)
Left Oblique164.50 (-56.50 to 730.00)
Nose45.50 (-25.00 to 94.50)
Right Oblique214.50 (-39.50 to 789.50)
PrimaryChange 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.

Time frame:
Baseline, 3 Months
Reported as:
Median · count of porphyrins
Change in Porphyrins at 3 Months From Baseline (Double Treatment Group)
count of porphyrinsDouble Treatment Arm
Front-160.50 (-266.00 to -1.00)
Left Oblique-145.50 (-263.00 to 158.50)
Nose3.00 (-66.00 to 60.00)
Right Oblique13.00 (-278.50 to 135.50)
PrimaryChange 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

Time frame:
Baseline, 1 Month
Reported as:
Median · count of red features
Change in Red Features at 1 Month From Baseline (Single Treatment Group)
count of red featuresSingle Treatment Arm
Front1.00 (-1.00 to 5.00)
Left Oblique-7.00 (-10.00 to 2.00)
Nose-1.00 (-3.00 to 10.00)
Right Oblique-2.00 (-7.00 to 12.00)
PrimaryChange 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

Time frame:
Baseline, 3 Months
Reported as:
Median · count of red features
Change in Red Features at 3 Months From Baseline (Single Treatment Group)
count of red featuresSingle Treatment Arm
Front2.00 (-6.00 to 5.00)
Left Oblique-7.00 (-12.00 to 7.00)
Nose0.00 (-4.00 to 3.00)
Right Oblique0.00 (-17.00 to 9.00)
PrimaryChange 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

Time frame:
Baseline, 1 Month
Reported as:
Median · count of red features
Change in Red Features at 1 Month From Baseline (Double Treatment Group)
count of red featuresDouble Treatment Arm
Front4.00 (1.50 to 9.00)
Left Oblique7.50 (-1.50 to 11.00)
Nose0.00 (-2.50 to 2.50)
Right Oblique3.50 (-14.00 to 8.50)
PrimaryChange 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

Time frame:
Baseline, 3 Months
Reported as:
Median · count of red features
Change in Red Features at 3 Months From Baseline (Double Treatment Group)
count of red featuresDouble Treatment Arm
Front2.00 (-0.50 to 9.50)
Left Oblique5.50 (1.00 to 15.00)
Nose1.00 (-2.00 to 3.00)
Right Oblique2.50 (-10.50 to 5.00)
PrimaryChange 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

Time frame:
Baseline, 1 Month
Reported as:
Median · unitless
Change in Texture at 1 Month From Baseline (Single Treatment Group)
unitlessSingle Treatment Arm
Front-14.00 (-125.00 to 521.00)
Left Oblique-3.00 (-336.00 to 354)
Nose-1.00 (-42.00 to 14.00)
Right Oblique68.00 (-99.00 to 453.00)
PrimaryChange 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

Time frame:
Baseline, 3 Months
Reported as:
Median · unitless
Change in Texture at 3 Months From Baseline (Single Treatment Group)
unitlessSingle Treatment Arm
Front64.00 (-210.00 to 147.00)
Left Oblique188.00 (45.00 to 302.00)
Nose30.00 (-30.00 to 302.00)
Right Oblique161.00 (19.00 to 396.00)
PrimaryChange 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

Time frame:
Baseline, 1 Month
Reported as:
Median · unitless
Change in Texture at 1 Month From Baseline (Double Treatment Group)
unitlessDouble Treatment Arm
Front20.50 (-216.00 to 413.00)
Left Oblique-198.00 (-569.00 to 155.00)
Nose4.00 (-19.00 to 41.50)
Right Oblique-225.50 (-506.00 to -25.00)
PrimaryChange 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

Time frame:
Baseline, 3 Months
Reported as:
Median · unitless
Change in Texture at 3 Months From Baseline (Double Treatment Group)
unitlessDouble Treatment Arm
Front-25.00 (-146.50 to 212.50)
Left Oblique82.00 (-141.00 to 236.00)
Nose16.50 (-2.50 to 43.00)
Right Oblique-72.00 (-246.00 to 171.00)
PrimaryChange 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

Time frame:
Baseline, 1 Month
Reported as:
Median · count of UV spots
Change in UV Spots at 1 Month From Baseline (Single Treatment Group)
count of UV spotsSingle Treatment Arm
Front-4.00 (-8.00 to -1.00)
Left Oblique-4.00 (-11.00 to 3.00)
Nose0.00 (-6.00 to 2.00)
Right Oblique0.00 (-1.00 to 11.00)
PrimaryChange 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

Time frame:
Baseline, 3 Months
Reported as:
Median · count of UV spots
Change in UV Spots at 3 Months From Baseline (Single Treatment Group)
count of UV spotsSingle Treatment Arm
Front-3.00 (-15.00 to 6.00)
Left Oblique-4.00 (-12.00 to 11.00)
Nose-2.00 (-3.00 to 1.00)
Right Oblique1.00 (-4.00 to 3.00)
PrimaryChange 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

Time frame:
Baseline, 1 Month
Reported as:
Median · count of UV spots
Change in UV Spots at 1 Month From Baseline (Double Treatment Group)
count of UV spotsDouble Treatment Group
Front-1.50 (-11.50 to 7.50)
Left Oblique5.00 (-19.50 to 11.50)
Nose-2.50 (-5.50 to 1.00)
Right Oblique-1.00 (-25.00 to 6.00)
PrimaryChange 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

Time frame:
Baseline, 3 Months
Reported as:
Median · count of UV spots
Change in UV Spots at 3 Months From Baseline (Double Treatment Group)
count of UV spotsDouble Treatment Arm
Front-1.00 (-15.00 to 4.50)
Left Oblique-7.50 (-15.50 to 13.50)
Nose-2.50 (-4.00 to 1.00)
Right Oblique4.50 (-7.50 to 10.50)
PrimaryChange 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

Time frame:
Baseline, 1 Month
Reported as:
Median · count of visible spots
Change in Visible Spots at 1 Month From Baseline (Single Treatment Group)
count of visible spotsSingle Treatment Arm
Frontal2.00 (0.00 to 12.00)
Left Oblique-3.00 (-6.00 to 4.00)
Nose-1.00 (-1.00 to 0.00)
Right Oblique3.00 (1.00 to 5.00)
PrimaryChange 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

Time frame:
Baseline, 3 Months
Reported as:
Median · count of visible spots
Change in Visible Spots at 3 Months From Baseline (Single Treatment Group)
count of visible spotsSingle Treatment Arm
Frontal6.00 (3.00 to 9.00)
Left Oblique1.00 (-3.00 to 4.00)
Nose0.00 (-1.00 to 5.00)
Right Oblique3.00 (-4.00 to 3.00)
PrimaryChange 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

Time frame:
Baseline, 1 Month
Reported as:
Median · count of visible spots
Change in Visible Spots at 1 Month From Baseline (Double Treatment Group)
count of visible spotsDouble Treatment Arm
Frontal6.00 (-12.50 to 20.50)
Left Oblique-6.50 (-11.50 to 6.50)
Nose-0.50 (-2.50 to 0.50)
Right Oblique-11.00 (-14.00 to 6.00)
PrimaryChange 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

Time frame:
Baseline, 3 Months
Reported as:
Median · count of visible spots
Change in Visible Spots at 3 Months From Baseline (Double Treatment Group)
count of visible spotsDouble Treatment Arm
Frontal-2.00 (-5.00 to 4.00)
Left Oblique0.00 (-7.50 to 8.50)
Nose-0.50 (-1.00 to 1.50)
Right Oblique-0.50 (-5.50 to 11.00)
PrimaryChange 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.

Time frame:
Baseline, 1 Month
Reported as:
Median · mm^2
Change in Total Wrinkle Area at 1 Month From Baseline (Single Treatment Group)
mm^2Single Treatment Arm
Front-1.00 (-3.00 to 0.00)
Left Oblique-13.00 (-17.00 to -3.00)
Nose-3.00 (-3.00 to 0.00)
Right Oblique5.00 (-63.00 to 12.00)
PrimaryChange 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.

Time frame:
Baseline, 3 Months
Reported as:
Median · mm^2
Change in Total Wrinkle Area at 3 Months From Baseline (Single Treatment Group)
mm^2Single Treatment Arm
Front-1.00 (-2.00 to 3.00)
Left Oblique-1.00 (-12.00 to 18.00)
Nose1.00 (-5.00 to 1.00)
Right Oblique5.00 (-24.00 to 24.00)
PrimaryChange 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.

Time frame:
Baseline, 1 Month
Reported as:
Median · mm^2
Change in Total Wrinkle Area at 1 Month From Baseline (Double Treatment Group)
mm^2Double Treatment Arm
Front0.50 (-3.00 to 1.00)
Left Oblique-14.50 (-42.00 to 0.50)
Nose-2.50 (-5.50 to -0.50)
Right Oblique-14.50 (-39.50 to -2.00)
PrimaryChange 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.

Time frame:
Baseline, 3 Months
Reported as:
Median · mm^2
Change in Total Wrinkle Area at 3 Months From Baseline (Double Treatment Group)
mm^2Double Treatment Arm
Front0.00 (-2.00 to 0.00)
Left Oblique12.00 (-16.00 to 21.50)
Nose-1.00 (-4.50 to 2.50)
Right Oblique-13.50 (-31.50 to 6.00)

Adverse events

Collected over 4 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Single Treatment Group Participants0/7 (0%)0/7 (0%)0/7 (0%)
Double Treatment Group Participants0/8 (0%)0/8 (0%)0/8 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Single Treatment ArmDouble Treatment ArmTotal
<=18 years000
Between 18 and 65 years7815
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)Single Treatment ArmDouble Treatment ArmTotal
Female7714
Male011
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Single Treatment ArmDouble Treatment ArmTotal
Hispanic or Latino123
Not Hispanic or Latino6612
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Single Treatment ArmDouble Treatment ArmTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White7815
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Single Treatment ArmDouble Treatment ArmTotal
United States7815
08

Study locations

1 site
  • University of Texas Southwestern Medical Center
    Dallas, Texas 75390, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Oct 21, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06091215
Lead sponsor
University of Texas Southwestern Medical Center
Collaborators
Sciton
Responsible party
Jeffrey M. Kenkel (Principle Investigator, University of Texas Southwestern Medical Center) — Principal investigator
First posted
Oct 19, 2023
Start date
Jan 1, 2024
Primary completion
Jun 11, 2024
Completion
Dec 31, 2024
Results posted
Jan 27, 2026
Last update
Jan 27, 2026

Study contacts

Jeffrey Kenkel, MD
principal investigator · UT Southwestern

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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