Sciton Joule System for Pigmentation Disorders

Overseen By Debby Noble

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Retinoids, Anticoagulants, Psychiatric drugs

Disqualifiers: Skin diseases, Scars, Tattoos, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 4-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of treatments for pigmentation issues such as sunspots or discoloration. It examines the effectiveness of Broad-Based Light (BBL), MOXI, and HALO treatments (part of the Sciton Joule System) in improving skin appearance. Participants will receive either one or two treatment sessions spaced a few weeks apart. The trial seeks healthy adults with lighter skin tones (Fitzpatrick types 1-4) who might benefit from skin resurfacing and are willing to avoid other cosmetic treatments during the study. As an unphased trial, it offers a unique opportunity to explore innovative treatment combinations for enhancing skin appearance.

Do I have to stop taking my current medications for the trial?

The trial requires stopping certain medications before participating. You must stop using Accutane or systemic retinoids 6 weeks prior, topical retinoids 4 weeks prior, and certain skin lightening medications 4 months prior. Additionally, you should not use antiplatelet agents, anticoagulants, or psychiatric drugs that impair understanding of the study.

What prior data suggests that the Sciton Joule System is safe for treating pigmentation disorders?

Research has shown that the combination of Broad Based Light (BBL), MOXI, and HALO treatments is generally well-tolerated. Studies have found that BBL treatments are safe, with most individuals experiencing only mild side effects like redness or temporary darkening of the skin. These effects usually resolve quickly, allowing individuals to resume normal activities soon after treatment.

Using these treatments together addresses various skin issues, such as pigmentation and texture. While individual experiences can vary, other studies have found these treatments safe for many patients. It is important to consult a doctor about any concerns before starting treatment to ensure it is the right choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Sciton Joule System for pigmentation disorders because it combines three innovative technologies: Broad Based Light (BBL), Fractionated 1927 (MOXI), and Dual Wavelength 2940/1470 (HALO). Unlike standard treatments like topical creams or chemical peels, this combination targets both surface and deeper skin layers, potentially offering more comprehensive results. The dual wavelength feature of HALO allows precise targeting of pigmentation while minimizing downtime, making it a promising option for those seeking faster recovery and enhanced skin tone improvement. This multi-faceted approach could provide more effective and longer-lasting results than existing methods.

What evidence suggests that the Sciton Joule System is effective for pigmentation disorders?

This trial will compare the effectiveness of single versus double treatments using the combination of Broad Based Light (BBL), MOXI, and HALO for pigmentation disorders. Research has shown that combining these treatments can help with skin pigmentation problems. Specifically, studies indicate that the 1927 nm laser in MOXI improves sun damage, such as sunspots and uneven skin tone. BBL uses light energy to warm the skin and encourage natural healing, aiding pigment issues. HALO employs two types of light to enhance skin texture and pigmentation. Together, these treatments have shown promise in addressing pigmentation and texture issues, suggesting effectiveness for pigmentation disorders. ^{3 6 7 8 9}

Who Is on the Research Team?

Jeffrey Kenkel, MD

Principal Investigator

UT Southwestern

Are You a Good Fit for This Trial?

This trial is for adults aged 20-75 with Fitzpatrick skin types 1-4 who could benefit from skin resurfacing. Participants must avoid other aesthetic treatments during the study, agree to a pregnancy test if applicable, and use effective birth control.

Inclusion Criteria

I am using an IUD for contraception.

I am between 20 and 75 years old and consider myself healthy.

I am using a form of hormonal birth control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 1-2 BBL/MOXI/HALO treatments, with the second treatment scheduled 4-8 weeks after the initial treatment

4-8 weeks

1-2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1 Month and 3 Months post final treatment

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The Sciton Joule System is being tested on up to 15 subjects at UT Southwestern Medical Center. This non-randomized study involves up to two treatments combining BBL (Broad Based Light), MOXI (Fractionated 1927), and HALO (Dual Wavelength 2940/1470) for pigmentation disorders.

How Is the Trial Designed?

Group I: Double Treatment Arm Active Control 1 Intervention

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

Group II: Single Treatment Arm Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Sciton

Industry Sponsor

Trials

20

Recruited

1,400+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06091215

Combining Broad Based Light (BBL), Fractionated 1927 ... Combining Broad Based Light, Fractionated 1927 and Dual Wavelength 2940/1470 for Diffuse Pigmentation, Texture and Actinic Changes ... Skin Pigmentation Disorders ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06091215?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(and%201927))&rank=6

Combining Broad Based Light (BBL), Fractionated 1927 ... Combining Broad Based Light, Fractionated 1927 and Dual Wavelength 2940/1470 for Diffuse Pigmentation, Texture and Actinic Changes. Conditions. Pigment Skin.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36950878/

Investigating the efficacy of a fractionated 1927 nm laser for ... These results demonstrate that fractionated, nonablative 1927 nm laser treatment is an effective modality for improving clinical and subclinical photodamage.

4. researchgate.net researchgate.net/publication/369473836_Investigating_the_efficacy_of_a_fractionated_1927_nm_laser_for_diffuse_dyspigmentation_and_actinic_changes

(PDF) Investigating the efficacy of a fractionated 1927 nm ... The purpose of this study was to quantify the magnitude and duration of actinic pigment and photodamage response in patients of Fitzpatrick Skin ...

5. aging.networkofcare.org aging.networkofcare.org/riverside/CommunityResources/ClinicalTrials/Detail/NCT06091215?keyword=%22Pigment%20Skin%22

Combining Broad Based Light (BBL), Fractionated 1927 ... 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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03970317

Safety and Efficacy of Broad Band Light In Motion Treatment It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11460752/

A Novel Combination of BroadBand Light (BBL® HEROTM ... Follow-up time was variable; in one patient, a marked reduction in hyperpigmentation was observed almost 20 months post-treatment. The results presented in this ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jocd.15632

Effectiveness of combination therapy of broadband light ... Our results show that BBL not only effectively reduced the pigmentation, but also the vascularization. As for the vessel clearance, long-pulsed ...

9. drdarrenmckeown.com drdarrenmckeown.com/treatments/bbl-treatment/answerpack/bbl-broadband-light-treatment/what-are-the-risks-of-bbl-laser-treatment/

What are the risks of BBL laser treatment? BBL treatments at McKeown Medical are safe and involve minimal downtime. While some redness or darkening of pigmentation may occur, most patients resume daily ...