Fractional CO2 Laser for the Treatment of Lichen Planus Pigmentosus

Overseen By Heather Goff, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Immunosuppressants, Anticoagulants, Isotretinoin, Gold therapy

Disqualifiers: Active skin infection, Pregnancy, Diabetes, others

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

Compensation: Varies

Number of Visits: 4

Duration: 1 session

Trial Summary

What is the purpose of this trial?

This trial will test a special laser treatment for people with a chronic skin condition called Lichen Planus Pigmentosus. The laser creates tiny injuries in the skin to help it heal and look better. The study aims to see if this treatment is safe and effective for these patients.

Will I have to stop taking my current medications?

The trial requires participants to refrain from using other topical medications besides those provided during the study. If you are on immunosuppressive medications, you cannot participate. The protocol does not specify about other medications, so it's best to discuss with the trial team.

What data supports the effectiveness of the CO2 fractional laser treatment?

Research shows that CO2 fractional lasers are effective in improving the appearance of scars after surgery and have fewer complications compared to older laser technologies. They have also been used to help with skin conditions involving inflammation. ^{1 2 3 4 5}

Is the CO2 fractional laser treatment generally safe for humans?

The CO2 fractional laser treatment is generally considered safe with fewer complications compared to older laser technologies, though some adverse events (unwanted side effects) can occur. It is important to follow pre- and postoperative care instructions to minimize risks. ^{2 4 5 6 7}

How does the CO2 fractional laser treatment differ from other treatments?

The CO2 fractional laser is unique because it is an ablative laser that provides excellent results with less downtime and fewer complications compared to older CO2 lasers. It works by creating tiny holes in the skin, promoting healing and collagen production, which makes it effective for skin resurfacing and treating certain cervical diseases. ^{2 4 8 9 10}

Research Team

Heather Goff, MD, MPH

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

Inclusion Criteria

Agree to not undergo any other procedures on affected area during the study

Agree to refrain from tanning for 6 months post-procedure

Willing and able to read, understand, and sign the consent form

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Preparation

Participants complete a one-month preoperative daily use of SPF 50+ sunscreen to reduce further sun damage and protect skin from increased photosensitivity.

4 weeks

Treatment

Participants receive fractional CO2 laser treatment on one half of the body, with the other half left untreated as a control.

1 session

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with limited in-person follow-ups and virtual check-ins.

24 weeks

3 visits (in-person), multiple virtual check-ins

Optional Treatment Extension

Participants may opt for treatment of the control side after the study end-point at no cost.

Treatment Details

Interventions

• CO2 fractional laser

Participant Groups

Group I: Treatment (CO2 fractional laser) arm Experimental Treatment 1 Intervention

CO2 fractional laser will be used to treat dyspigmentation in lichen planus pigmentosus in one half along sagittal midline section in each subject.

Group II: No treatment (Control) arm Active Control 1 Intervention

One half along sagittal midline section in each subject will not receive the CO2 fractional laser treatment.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Findings from Research

Ablative carbon dioxide fractional laser treatment applied 2 to 3 weeks after thyroid surgery significantly improved the appearance of scars, as indicated by lower Vancouver Scar Scale scores in 23 women.

The treatment was found to be both effective and safe, with 12 out of 23 participants showing over 51% clinical improvement in scar appearance three months post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early postoperative treatment of thyroidectomy scars using a fractional carbon dioxide laser. Jung, JY., Jeong, JJ., Roh, HJ., et al.[2022]

In a study of 373 CO₂ laser treatments on 287 patients, adverse events (AEs) occurred in 12.6% of treatments, with the most common being allergic dermatitis (4.6%) and acneiform breakouts (3.5%).

The risk of AEs increased significantly when multiple body areas were treated simultaneously, with 37.5% of patients experiencing AEs when three areas were treated, while subsequent treatments on the same area after healing showed no increased risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of fractionated carbon dioxide laser: review of 373 treatments. Campbell, TM., Goldman, MP.[2012]

The novel fractional CO2 laser developed for treating cervical diseases demonstrated greater depth of penetration and more consistent laser spot size compared to a conventional CO2 laser, indicating improved efficacy.

Both the novel and conventional CO2 lasers showed similar side effects, suggesting that the new apparatus is as safe as the traditional method while offering enhanced performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigation of the efficiency and stability of a novel visualized lattice CO2 laser-based gynecological therapeutic apparatus for the treatment of cervical diseases in rhesus monkeys. Chen, F., Gan, Y., Wang, HW.[2022]

References

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

Effects of ablative 10,600-nm carbon dioxide fractional laser therapy on suppurative diseases of the skin: a case series of 12 patients. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Research trends and hotspot analysis of fractional carbon dioxide laser: A bibliometric and visualized analysis via Citespace. [2022]

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

Early postoperative treatment of thyroidectomy scars using a fractional carbon dioxide laser. [2022]

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

Fractional carbon dioxide laser resurfacing. [2021]

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

Adverse events of fractionated carbon dioxide laser: review of 373 treatments. [2012]

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

Hybrid fractional laser facial resurfacing: A comparison between a single treatment at high settings versus multiple treatments at low to moderate settings. [2023]

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

A multiplexed 1,440 and 1,320 nm laser for treatment of chronic photodamage. [2011]

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

High-peak-power, pulsed CO(2) laser light delivery by hollow glass waveguides. [2019]

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

Switch-less operation of a TEA CO2 laser. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Investigation of the efficiency and stability of a novel visualized lattice CO2 laser-based gynecological therapeutic apparatus for the treatment of cervical diseases in rhesus monkeys. [2022]