Fractionated 1927nm Laser for Hyperpigmentation

Overseen By Abby Culver, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Antiplatelets, Anticoagulants, NSAIDs, Immunosuppressives

Disqualifiers: Skin cancer, Active acne, Diabetes, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 6

Duration: 2 months

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to assess the efficacy of 1927nm non-ablative fractionated laser therapy to treat hyperpigmentation in patients ages 18-75 with Fitzpatrick Skin Phototypes V and VI and explore an effective, adjunctive pre- and post-procedural regimen to prevent iatrogenic dyspigmentation or scarring in this population.

Research Team

Jeffrey Kenkel, MD

Principal Investigator

UT Southwestern- Department of Plastic Surgery

Eligibility Criteria

Adults aged 18-75 with darker skin tones (Fitzpatrick Skin Phototypes V and VI) who have noticeable hyperpigmentation on their face and are seeking treatment. Participants must be willing to avoid other aesthetic treatments, follow study procedures, use approved birth control if applicable, and not have any health conditions that could interfere with the trial.

Inclusion Criteria

Fitzpatrick Skin Phototype V and VI

Individuals who can read, speak, write, and understand English and who are willing to provide written informed consent

I am willing and able to follow all study instructions and treatments.

Exclusion Criteria

History of poor cooperation, unreliability, or noncompliance with medical treatment

I have a condition that could affect my skin's healing.

I am able to understand instructions and give informed consent.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive 1927nm non-ablative fractionated laser therapy for hyperpigmentation with treatments on Day 0, Day 30, and Day 60

2 months

3 visits (in-person)

Follow-up

Participants are monitored for changes in hyperpigmentation and adverse events at 1-month and 3-month follow-up visits

2 months

2 visits (in-person)

Treatment Details

Interventions

• MOXI

Trial Overview The trial is testing the effectiveness of a non-ablative fractionated laser therapy called MOXI for treating facial hyperpigmentation in individuals with darker skin types. It also aims to find a safe pre- and post-treatment skincare routine to prevent unwanted pigmentation or scarring.

Participant Groups

Group I: Healthy Participants- Pre-Ttreatment Only Experimental Treatment 1 Intervention

Subjects who are interested in treatment for hyperpigmentation will be enrolled for this study. Subjects will be pre-treated with tretinoin/hydroquinone prior to treatments. No post-treatment care.

Group II: Healthy Participants- Post-Treatment Only Experimental Treatment 1 Intervention

Subjects who are interested in treatment for hyperpigmentation will be enrolled for this study. Subjects will wash out of any topical medications and will receive treatment. Post-treatment care will include use of temovate for 4 days.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+