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

Trial Summary

What is the purpose of this trial?

To study the effect of fractionated 1927-nm non ablative thulium laser in reduction of post inflammatory hyperpigmentation (PIH) using a validated and reproducible model for studying PIH. * Determine if there is aa reduction in PIH in patients treated with three (3) monthly sessions of fractionated 1927-nm non ablative thulium laser * Determine if there is efficacy of post-procedure clobetasol propionate 0.05% ointment in the management of PIH * Determine the histological and molecular changes that occur with laser and laser plus topical steroid treatment compared to untreated skin

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 data supports the effectiveness of the 1927 nm Thulium Laser treatment for hyperpigmentation?

Research shows that the 1927 nm Thulium Laser is effective in treating melasma, a type of skin discoloration, with significant improvement in skin appearance after treatment. Additionally, it has been shown to improve facial photopigmentation and aging, making it a promising option for hyperpigmentation. ^{1 2 3 4 5}

Is the 1927 nm Thulium Laser safe for treating hyperpigmentation?

The 1927 nm Thulium Laser is generally considered safe for treating skin conditions like melasma, with studies showing no major side effects. However, there have been rare cases of bacterial infections following treatment, which were quickly treated without long-term issues. ^{1 2 3 5 6}

How does the 1927 nm Thulium Laser treatment for hyperpigmentation differ from other treatments?

The 1927 nm Thulium Laser is unique because it is a non-ablative laser, meaning it treats the skin without removing layers, making it safer with fewer side effects. It specifically targets the epidermis (outer skin layer) to improve pigmentation issues like melasma, and has been shown to be effective with minimal downtime compared to other laser treatments. ^{1 2 3 4 7}

Eligibility Criteria

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).

Patient able to sign a consent form

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. England 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. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Bacterial infections following non-ablative fractional laser treatment: a case series and discussion. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Investigating the efficacy of a fractionated 1927 nm laser for diffuse dyspigmentation and actinic changes. [2023]

4. England 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. [2019]

5. United States 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 [2019]

6. United States 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. [2022]

7. United States 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. [2022]