Laser Treatment for Hyperpigmentation

Overseen By Mohammad Tasneem, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Henry Ford Health System

Must not be taking: Oral pigmentary, Topical pigmentary

Disqualifiers: Skin dyspigmentation, Birth marks, Tattoos, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 3 months

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new laser treatment for reducing post-inflammatory hyperpigmentation (PIH), the darkening of skin often following an injury or inflammation. The study tests whether the Fractionated 1927-nm Non Ablative Thulium Laser, combined with a steroid ointment, can effectively lighten these dark spots and examines the changes it causes in the skin. Ideal participants have medium to dark skin (phototypes IV-VI), experience PIH, and have stopped using other treatments for this condition. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could lead to new treatment options for PIH.

Will I have to stop taking my current medications?

You will need to stop taking all oral and topical medications used to treat pigmentary issues, except for sunscreen, on the buttocks one month before starting the treatment.

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

Research has shown that the 1927-nm thulium laser is generally safe for treating skin issues like dark spots. Studies have found that this laser effectively reduces signs of skin damage without causing major side effects. For instance, one study reported that 70% of patients were "satisfied" or "extremely satisfied" with their results, highlighting both safety and effectiveness. Another study noted that this laser treatment usually doesn't cause significant negative effects. Overall, patients tolerate the laser well, making it a promising option for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Fractionated 1927-nm Non Ablative Thulium Laser is unique because it uses a non-invasive approach to target hyperpigmentation, offering a potentially safer and more comfortable alternative to traditional methods like chemical peels and ablative lasers. Unlike these conventional treatments that may require longer recovery times due to their aggressive nature, the Thulium Laser is non-ablative, meaning it works beneath the skin's surface without damaging the outer layer. This can lead to less downtime and reduced risk of side effects. Researchers are excited about this treatment as it combines the precision of laser technology with the gentleness of a non-invasive procedure, potentially improving both safety and patient satisfaction.

What evidence suggests that the fractionated 1927-nm non ablative thulium laser is effective for reducing post inflammatory hyperpigmentation?

Research has shown that the 1927-nm thulium laser, which participants in this trial will receive, effectively treats dark spots on the skin, including post-inflammatory hyperpigmentation (PIH). One study found that 70% of patients reported being "satisfied" or "extremely satisfied" with their treatment results, highlighting its positive impact. This laser targets and reduces dark spots without harming the surrounding skin. It also improves other skin issues like wrinkles and sun damage. These findings support the laser's potential for reducing PIH and enhancing overall skin appearance. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with darker skin types (IV-VI) who have post-inflammatory hyperpigmentation. Participants must stop all pigment-related treatments except sunscreen on the buttocks one month before starting and be able to understand study risks and consent.

Inclusion Criteria

I stopped all oral and topical treatments for skin color changes on my buttocks, except sunscreen, a month ago.

You have a darker skin type (such as tan or brown skin).

I understand what participating in the study involves and its risks.

Exclusion Criteria

You have skin markings or birthmarks on your buttocks that could make it hard to get clear study results.

A patient who is lactating, pregnant, or planning to become pregnant

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 three monthly sessions of fractionated 1927-nm non ablative thulium laser

3 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments such as visual examination, photography, and spectroscopy

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Fractionated 1927-nm Non Ablative Thulium Laser

Trial Overview The trial tests if three monthly sessions of a fractionated 1927-nm non-ablative thulium laser can reduce hyperpigmentation. It also examines the effectiveness of clobetasol propionate ointment after treatment, as well as histological and molecular changes in treated versus untreated skin.

How Is the Trial Designed?

Group I: Fractional laser patients treated with laser Experimental Treatment 1 Intervention

Laser with topical steroid and laser with vehicle.

Fractionated 1927-nm Non Ablative Thulium Laser is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Fractionated 1927-nm Non Ablative Thulium Laser for:

• Post-inflammatory hyperpigmentation (PIH)
• Melasma
• Photoaging
• Dyschromia
• Actinic keratosis (AK)

Approved in European Union as 1927 nm Thulium Laser for:

• Melasma
• Photoaging
• Dyschromia
• Actinic keratosis (AK)

Approved in Canada as Thulium Refresh Laser for:

• Post-inflammatory hyperpigmentation (PIH)
• Melasma
• Photoaging
• Dyschromia

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+

Published Research Related to This Trial

In a study involving 20 subjects, the 755 nm picosecond pulsed alexandrite laser demonstrated significantly greater improvements in facial photopigmentation and skin quality compared to the 1927 nm non-ablative thulium laser after treatment.

Both laser treatments were effective, but the picosecond laser was associated with less pain and fewer side effects, making it a more favorable option for patients seeking treatment for photoaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, single-blind, study evaluating a 755-nm picosecond pulsed Alexandrite laser vs. a non-ablative 1927-nm fractionated thulium laser for the treatment of facial photopigmentation and aging. Serra, M., Bohnert, K., Sadick, N.[2019]

The combination of 1927 nm thulium fiber laser and 0.05% tretinoin lotion was well tolerated by patients and resulted in significant reductions in facial hyperpigmentation and photodamage, indicating its safety and efficacy.

However, at 30 days post-treatment, patients using tretinoin reported lower satisfaction and perceived improvement compared to those using a vehicle, suggesting that while effective, the combination may not enhance patient experience in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-Center, Prospective, Double-Blind, Evaluator-Blind, non-Randomized, Vehicle-Controlled Trial With a 1927 Nm Non-Ablative Fractionated Laser and Topical 0.05% Tretinoin Lotion for Facial Dyspigmentation and Photodamage. Almukhtar, R., Carr, E., Angra, K., et al.[2022]

In a study of 100 patients treated with the 1927 nm fractional Thulium fiber laser for melasma, significant improvements were observed in skin pigmentation, with MASI scores decreasing from a mean of 11.8 before treatment to 3.4 after two sessions.

The treatment was found to be safe, with no major side effects reported, indicating that this laser therapy could be a reliable option for managing melasma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of 1927 nm fractional Thulium fiber laser for the treatment of melasma: a retrospective study of 100 patients. Kurmuş, G., Tatlıparmak, A., Aksoy, B., et al.[2020]

A study involving 19 subjects demonstrated that combining high-intensity precision radiofrequency (RF) and fractional laser therapy significantly improved skin quality in 84% of participants after three treatment sessions, indicating the efficacy of this combined approach for rejuvenating the aging face and neck.

The treatment was generally safe, with common side effects including erythema and edema, but 90% of subjects reported improved skin quality and 74% expressed satisfaction with the results, highlighting the positive reception of the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Combining High-Intensity Focused Radiofrequency and Non-Ablative Fractional Laser for Improving the Appearance of the Aging Face and Neck Moradi, A., Weiner, SF.[2019]

Non-ablative fractional laser procedures, particularly with the 1550/1927 nm lasers, are generally safe but have recently been associated with rare cases of bacterial infections, including one severe case leading to sepsis.

Prompt identification and treatment of these infections are crucial, as they can progress rapidly and result in serious complications, emphasizing the need for close monitoring after laser treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bacterial infections following non-ablative fractional laser treatment: a case series and discussion. Xu, LY., Kilmer, SL., Ross, EV., et al.[2015]

In a study involving 27 female patients aged 29 to 74, treatment with a fractionated nonablative 1927 nm laser significantly improved dyspigmentation, with a notable reduction in spots and brown spots observed at 1 month post-treatment.

No serious adverse events were reported, indicating that this laser treatment is safe, and while improvements were maintained at 3 months for some pigment types, ongoing treatments may be necessary to sustain results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating the efficacy of a fractionated 1927 nm laser for diffuse dyspigmentation and actinic changes. Vingan, NR., Panton, JA., Barillas, J., et al.[2023]

The 1,927-nm thulium fiber fractional laser is an effective and safe treatment for photoaging and melasma in Asians, as demonstrated by significant clinical improvement observed in 25 participants after three treatments.

Participants reported high satisfaction rates with the treatment, and no severe adverse events were noted, with a manageable average pain score of 4.8 on a visual analog scale.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Split-face study using a 1,927-nm thulium fiber fractional laser to treat photoaging and melasma in Asian skin. Lee, HM., Haw, S., Kim, JK., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36950052/

Prospective study of efficacy and safety of non-ablative ... 70% patients reporting "satisfied" or "extremely satisfied". Conclusions: In this study, FTL was found to be a safe and effective treatment ...

2. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2023.1076848/full

Prospective study of efficacy and safety of non-ablative ... The 1927 nm fractional thulium fiber laser (FTL) reduces the superficial signs of photoaging such as dyspigmentation, wrinkles and actinic damage.

3. withpower.com withpower.com/trial/phase-hyperpigmentation-11-2023-3d953

Laser Treatment for Hyperpigmentation Trial Overview The trial tests if three monthly sessions of a fractionated 1927-nm non-ablative thulium laser can reduce hyperpigmentation. It also examines the ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8016558/

1927 nm Thulium Laser Successfully Treats ... 1927 nm wavelength laser treatment followed by topical hydroquinone 4% cream for 6 weeks is a safe and effective modality for improving PIH in patients with ...

5. northsidedermatology.com.au northsidedermatology.com.au/procedure/aesthetic-dermatology/laser/lasemd/

LaseMD Treatment Melbourne - Northside Dermatology LaseMD Ultra is a 1927nm non-ablative fractional thulium laser. A fractional laser treats only a fraction of skin tissue at a time.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33259661/

Non-Ablative 1927 nm Fractional Thulium Fiber Laser In this study, we demonstrated the efficacy and safety of the non-ablative 1927 nm fractional thulium fiber laser (TFL, LASEMD™; Lutronic ...

7. researchgate.net researchgate.net/profile/Goekce-Kurmus/publication/337059512_Efficacy_and_safety_of_1927_nm_fractional_Thulium_fiber_laser_for_the_treatment_of_melasma_a_retrospective_study_of_100_patients/links/5dd64beb458515cd48b0045c/Efficacy-and-safety-of-1927-nm-fractional-Thulium-fiber-laser-for-the-treatment-of-melasma-a-retrospective-study-of-100-patients.pdf

Efficacy-and-safety-of-1927-nm-fractional-Thulium-fiber- ... the male scalp using 1,927 nm non-ablative fractional thulium fiber ... Adverse events of non-ablative fractional laser.