Pigment SkinNCT06091215

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

A study testing Sciton Joule System in people with Pigment Skin, run by University of Texas Southwestern Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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 more about this study

Who is it for?: Ages 20 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Pigment Skin
What is being tested?: Sciton Joule System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 1 Jan 2024to 31 Dec 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

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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.

Who cannot join

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:

Show all 34Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Texas Southwestern Medical Center
Dallas, Texas, 75390

Other trials in United States

About this study

Official title: Combining Broad Based Light, Fractionated 1927 and Dual Wavelength 2940/1470 for Diffuse Pigmentation, Texture and Actinic Changes

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.

Conditions: Pigment Skin
Being tested: Sciton Joule System
Medical subject headings: Pigmentation Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sciton Joule SystemDevice
Sciton Joule System

Study groups in NCT06091215
Study group	Role	What they receive
Single Treatment Arm	Active comparator	Subjects will receive a single treatment of BBL/MOXI/HALO Receives: Device: Sciton Joule System
Double Treatment Arm	Active comparator	Subjects will receive double treatment of BBL/MOXI/HALO 4-6 weeks apart. Receives: Device: Sciton Joule System

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202431 Dec 2024

First posted19 Oct 2023
Study start1 Jan 2024
Primary completion11 Jun 2024
Study completion31 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pigment SkinStudies of the same condition, open and under way.
More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Subjects will receive 1-2 combination treatments.
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06091215
Sponsor's protocol ID: STU-2023-1040
Status last verified: Nov 2025
First submitted: 13 Oct 2023
Last updated: 27 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
Not yet recruitingPhase 2/3
Two Trials to Evaluate TEV-53408 in Participants With Non-Segmental Vitiligo
Vitiligo
RecruitingObservational study
Clinical and Basic Investigations Into Hermansky-Pudlak Syndrome
Hermansky-Pudlak Syndrome (HPS)
RecruitingPhase 2
A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo
Vitiligo, Non-Segmental Vitiligo (NSV)

All Pigment Skin trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Combining Broad Based Light, Fractionated 1927 and Dual Wavelength 2940/1470 for Diffuse Pigmentation, Texture and Actinic Changes
ClinicalTrials.gov ID: NCT06091215
Acronym / sponsor ID: STU-2023-1040
Conditions: Pigment Skin
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: University of Texas Southwestern Medical CenterUniversity, hospital or other
Collaborators: Sciton
Study start: 1 Jan 2024 (actual)
Primary completion: 11 Jun 2024 (actual)
Study completion: 31 Dec 2024 (actual)
First posted: 19 Oct 2023 (actual)
Results: Posted 27 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Subjects will receive 1-2 combination treatments.

Arm	Type	Receives
Single Treatment Arm	Active comparator	Device: Sciton Joule SystemSubjects will receive a single treatment of BBL/MOXI/HALO
Double Treatment Arm	Active comparator	Device: Sciton Joule SystemSubjects will receive double treatment of BBL/MOXI/HALO 4-6 weeks apart.

Who may qualify

Ages: 20 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

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:

Key exclusion criteria (34 listed)

Fitzpatrick skin type V-VI
Known allergies to general skin care products
Sensitivity to topical local anesthetic
Current or recent history of skin diseases:
Significant scars in the treatment area:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sciton Joule SystemSciton Joule System	Device	Double Treatment Arm, Single Treatment Arm

Primary outcome

Change in Brown Spots at 1 Month From Baseline (Single Treatment Group)
Time frame: Baseline, 1 Month
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
Change in Brown Spots at 3 Months From Baseline (Single Treatment Group)
Time frame: Baseline, 3 Months
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
Change in Brown Spots at 1 Month From Baseline (Double Treatment Group)
Time frame: Baseline, 1 Month
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
Change in Brown Spots at 3 Months From Baseline (Double Treatment Group)
Time frame: Baseline, 3 Months
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
Change in Pores at 1 Month From Baseline (Single Treatment Group)
Time frame: Baseline, 1 Month
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.
Change in Pores at 3 Months From Baseline (Single Treatment Group)
Time frame: Baseline, 3 Months
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.
Change in Pores at 1 Month From Baseline (Double Treatment Group)
Time frame: Baseline, 1 Month
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
Change in Pores at 3 Months From Baseline (Double Treatment Group)
Time frame: Baseline, 3 Months
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.
Change in Porphyrins at 1 Month From Baseline (Single Treatment Group)
Time frame: Baseline, 1 Month
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.
Change in Porphyrins at 3 Months From Baseline (Single Treatment Group)
Time frame: Baseline, 3 Months
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.
Change in Porphyrins at 1 Month From Baseline (Double Treatment Group)
Time frame: Baseline, 1 Month
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.
Change in Porphyrins at 3 Months From Baseline (Double Treatment Group)
Time frame: Baseline, 3 Months
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.
Change in Red Features at 1 Month From Baseline (Single Treatment Group)
Time frame: Baseline, 1 Month
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
Change in Red Features at 3 Months From Baseline (Single Treatment Group)
Time frame: Baseline, 3 Months
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
Change in Red Features at 1 Month From Baseline (Double Treatment Group)
Time frame: Baseline, 1 Month
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
Change in Red Features at 3 Months From Baseline (Double Treatment Group)
Time frame: Baseline, 3 Months
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
Change in Texture at 1 Month From Baseline (Single Treatment Group)
Time frame: Baseline, 1 Month
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
Change in Texture at 3 Months From Baseline (Single Treatment Group)
Time frame: Baseline, 3 Months
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
Change in Texture at 1 Month From Baseline (Double Treatment Group)
Time frame: Baseline, 1 Month
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
Change in Texture at 3 Months From Baseline (Double Treatment Group)
Time frame: Baseline, 3 Months
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
Change in UV Spots at 1 Month From Baseline (Single Treatment Group)
Time frame: Baseline, 1 Month
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
Change in UV Spots at 3 Months From Baseline (Single Treatment Group)
Time frame: Baseline, 3 Months
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
Change in UV Spots at 1 Month From Baseline (Double Treatment Group)
Time frame: Baseline, 1 Month
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
Change in UV Spots at 3 Months From Baseline (Double Treatment Group)
Time frame: Baseline, 3 Months
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
Change in Visible Spots at 1 Month From Baseline (Single Treatment Group)
Time frame: Baseline, 1 Month
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
Change in Visible Spots at 3 Months From Baseline (Single Treatment Group)
Time frame: Baseline, 3 Months
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
Change in Visible Spots at 1 Month From Baseline (Double Treatment Group)
Time frame: Baseline, 1 Month
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
Change in Visible Spots at 3 Months From Baseline (Double Treatment Group)
Time frame: Baseline, 3 Months
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
Change in Total Wrinkle Area at 1 Month From Baseline (Single Treatment Group)
Time frame: Baseline, 1 Month
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.
Change in Total Wrinkle Area at 3 Months From Baseline (Single Treatment Group)
Time frame: Baseline, 3 Months
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.
Change in Total Wrinkle Area at 1 Month From Baseline (Double Treatment Group)
Time frame: Baseline, 1 Month
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.
Change in Total Wrinkle Area at 3 Months From Baseline (Double Treatment Group)
Time frame: Baseline, 3 Months
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.

Results and safety

Results posted to the registry on 27 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Participants- Single Treatment Group	7	7
Healthy Participants- Double Treatment Group	8	8

Primary outcome: Change in Brown Spots at 1 Month From Baseline (Single Treatment Group)

Time frame: Baseline, 1 Month. Median (Inter-Quartile Range). Unit: count of spots

Measure	Single Treatment Arm n = 7
Front	12.00 (-2.00 to 17.00)
Left Oblique	5.00 (-11.00 to 7.00)
Nose	0.00 (-3.00 to 1.00)
Right Oblique	5.00 (-11.00 to 5.00)

Population analysed: Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.

Primary outcome: Change in Brown Spots at 3 Months From Baseline (Single Treatment Group)

Time frame: Baseline, 3 Months. Median (Inter-Quartile Range). Unit: count of spots

Measure	Single Treatment Arm n = 7
Front	8.00 (6.00 to 12.00)
Left Oblique	.00 (-2.00 to 25.00)
Nose	3.00 (-1.00 to 5.00)
Right Oblique	9.00 (-2.00 to 25.00)

Primary outcome: Change in Brown Spots at 1 Month From Baseline (Double Treatment Group)

Time frame: Baseline, 1 Month. Median (Inter-Quartile Range). Unit: count of spots

Measure	Double Treatment Arm n = 8
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)

Primary outcome: Change in Brown Spots at 3 Months From Baseline (Double Treatment Group)

Time frame: Baseline, 3 Months. Median (Inter-Quartile Range). Unit: count of spots

Measure	Double Treatment Arm n = 8
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 Oblique	8.50 (-14.00 to 22.50)

Adverse events

Time frame: 4 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Treatment Group Participants	0 of 7 (0%)	0 of 7 (0%)	0 of 7
Double Treatment Group Participants	0 of 8 (0%)	0 of 8 (0%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeffrey Kenkel, MD principal investigator

UT Southwestern

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sciton Joule System in people with Pigment Skin, run by University of Texas Southwestern Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Brown Spots at 1 Month From Baseline (Single Treatment Group) (time frame: Baseline, 1 Month). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06091215.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.