Fractionated 1927nm Laser for Hyperpigmentation

JB
AC
Overseen ByAbby Culver, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Texas Southwestern Medical Center
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a laser treatment called MOXI to evaluate its effectiveness in treating hyperpigmentation, a condition causing dark patches on the skin. Researchers aim to determine the safest and most effective use of this laser, particularly for individuals with darker skin tones (Fitzpatrick Skin Phototypes V and VI). The trial includes two groups: one receives a special pre-treatment, while the other receives post-treatment care to compare the effectiveness of each method. Individuals with noticeable facial hyperpigmentation who are willing to pause other skin treatments may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for hyperpigmentation.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that certain therapies and medications might interfere with the study. It's best to discuss your specific medications with the study team to see if they might affect your participation.

What prior data suggests that this laser treatment is safe for hyperpigmentation?

Research has shown that the 1927 nm non-ablative fractionated laser, known as MOXI, is generally safe for treating skin discoloration. In past studies, no negative effects occurred with its use. Patients did not experience unwanted darkening of their skin after treatment. Most patients reported being "satisfied" or "extremely satisfied" with their results.

The MOXI laser has been tested on individuals with darker skin tones and demonstrated significant improvement in reducing dark spots. Importantly, no negative side effects were observed during these treatments. This suggests that the laser is well-tolerated and a safe option for those considering joining a clinical trial.12345

Why are researchers excited about this trial?

Researchers are excited about the use of the fractionated 1927nm laser, known as MOXI, for treating hyperpigmentation because it offers a non-invasive approach with potentially fewer side effects compared to traditional methods like topical creams, chemical peels, or intense pulsed light therapy. Unlike these methods, which often require prolonged use and can cause irritation, MOXI targets the skin more precisely, using laser technology to address pigmentation issues at their source. This precise targeting can lead to faster and more noticeable improvements, making it a promising option for those seeking quicker results with minimal downtime.

What evidence suggests that the 1927nm laser treatment could be effective for hyperpigmentation?

Research shows that the MOXI laser, a type of 1927nm laser, effectively treats dark spots on the skin. Studies have found a noticeable improvement in brown spots, with a 9.9% reduction in pigment over time. One study noted a 16% decrease in spots caused by UV exposure and a 7% decrease in brown spots. These results suggest that MOXI can effectively reduce dark spots and improve skin appearance. The laser targets and breaks down excess pigment in the skin, helping to even out skin tone. Participants in this trial will be divided into two groups: one group will receive pre-treatment with tretinoin/hydroquinone, and the other group will receive post-treatment care with temovate.13678

Who Is on the Research Team?

JK

Jeffrey Kenkel, MD

Principal Investigator

UT Southwestern- Department of Plastic Surgery

Are You a Good Fit for This Trial?

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.
See 6 more

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.
See 21 more

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Healthy Participants- Pre-Ttreatment OnlyExperimental Treatment1 Intervention
Group II: Healthy Participants- Post-Treatment OnlyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36950878/
Investigating the efficacy of a fractionated 1927 nm laser for ...At 3 months, Brown spots remained significantly improved compared to baseline (p = 0.05). Analysis showed 9.9% improvement in pigment on the ...
Investigating the efficacy of a fractionated 1927 nm laser for ...At 3 months, Brown spots remained significantly improved compared to baseline (p = 0.05). Analysis showed 9.9% improvement in pigment on the ...
Fractionated 1927nm Laser for Diffuse Pigmentation and ...This is a prospective, non-controlled study where subjects will receive treatment using f1927 devices and will be treated twice over the affected areas of the ...
(PDF) Investigating the efficacy of a fractionated 1927 nm ...The results showed a statistically significant reduction in UVinduced spots (16%) and brown spots (7%). ... ... This highlights the importance ...
Investigating the efficacy of a fractionated 1927 nm laser for ...Conclusion: These results demonstrate that fractionated, nonablative 1927nm laser treatment is an effective modality for improving clinical ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36950052/
Prospective study of efficacy and safety of non-ablative ...No post-inflammatory hyperpigmentation changes or adverse events were observed. 70% patients reporting "satisfied" or "extremely satisfied". ...
Prospective study of efficacy and safety of non-ablative ...No post-inflammatory hyperpigmentation changes or adverse events were observed. 70% patients reporting “satisfied” or “extremely satisfied”. ...
The Safety and Efficacy of Treatment With a 1927-nm ...No adverse events were noted. Conclusion: The nonablative, fractional, 1,927-nm diode laser produced significant improvement in hyperpigmentation in Fitzpatrick ...
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