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

15 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jeffrey Kenkel, MD

Principal Investigator

UT Southwestern

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+