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Laser Therapy

Treatment (CO2 fractional laser) arm for Lichen Planus Pigmentosus

N/A
Waitlist Available
Led By Heather Goff, MD, MPH
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Agree to not undergo any other procedures on affected area during the study
Agree to refrain from tanning for 6 months post-procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks post treatment
Awards & highlights

Study Summary

This study will assess the safety and efficacy of fractional carbon dioxide (CO2) laser treatment for Lichen Planus Pigmentosus (LPP). LPP is a chronic pigmentary disorder typically involving the forehead, lateral cheeks, and occasionally other sun-exposed areas such as the forearms. Clinically, LPP appears as a reticulated brown to black macules and patches. Previously studied effective treatments of LPP include topical tacrolimus and corticosteroids. LPP is often recalcitrant to therapy, with chronic maintenance treatment needed to prevent repigmentation. There are few reports of laser modalities being used to treat LPP, with Nd:YAG being the only published laser modality to be attempted. Although topical therapies are relatively safe, there is a lack of satisfactory treatment options for this patient population. Fractional CO2 laser has been widely used for photoaging due to its effectiveness and high safety profile. Clinically evident improvement can be appreciated even after only one session of treatment. Ablative fractional laser resurfacing is both safe and effective for the treatment of the vascular, pigmentary and textural components of skin disorders. No data exist regarding the use of fractional CO2 laser for management of LPP. This study hopes to fulfill this purpose. The study subjects' body will be divided into two equal halves along sagittal midline section with one side receiving treatment with fractional CO2 laser (experimental) and the other left untreated (control)

Eligible Conditions
  • Lichen Planus Pigmentosus

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Improvement in dyspigmentation at 12 weeks post treatment
Improvement in dyspigmentation at 24 weeks post treatment
Secondary outcome measures
Overall Subject Satisfaction assessed at 12 weeks post treatment
Overall Subject Satisfaction assessed at 24 weeks post treatment

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment (CO2 fractional laser) armExperimental Treatment1 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) armActive Control1 Intervention
One half along sagittal midline section in each subject will not receive the CO2 fractional laser treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CO2 fractional laser
2019
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,043 Previous Clinical Trials
1,053,550 Total Patients Enrolled
Heather Goff, MD, MPHPrincipal InvestigatorUT Southwestern Medical Center

Frequently Asked Questions

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~0 spots leftby Mar 2025