Fractional CO2 Laser for the Treatment of Lichen Planus Pigmentosus

NCT05170308 | Withdrawn DMC FDA Device

• 1 other identifier: STU-2021-0551
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Lichen Planus Pigmentosus

Outcome Measures

Primary Outcomes (2)

• Improvement in dyspigmentation at 12 weeks post treatment

  Improvement in dyspigmentation at 12 weeks post treatment is assessed by the Physician's Global Aesthetic Improvement Scale which is a 11-point scale. Each dermatologist from an independent panel (blinded to treatment parameters and the treatment laterality at each photograph time point) will be asked to identify the baseline and post-treatment images from randomized, paired images for all subjects. Reviewers will rate improvement in LPP in 10% increments on an 11-point scale (0% no improvement to 100% or complete clearance).

  12 weeks post treatment

• Improvement in dyspigmentation at 24 weeks post treatment

  Improvement in dyspigmentation at 24 weeks post treatment is assessed by the Physician's Global Aesthetic Improvement Scale which is a 11-point scale. Each dermatologist from an independent panel (blinded to treatment parameters and the treatment laterality at each photograph time point) will be asked to identify the baseline and post-treatment images from randomized, paired images for all subjects. Reviewers will rate improvement in LPP in 10% increments on an 11-point scale (0% no improvement to 100% or complete clearance).

  24 weeks post treatment

Secondary Outcomes (2)

• Overall Subject Satisfaction assessed at 12 weeks post treatment

  12 weeks post treatment

• Overall Subject Satisfaction assessed at 24 weeks post treatment

  24 weeks post treatment

Study Arms (2)

Treatment (CO2 fractional laser) arm

OTHER

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

Device: CO2 fractional laser

No treatment (Control) arm

NO INTERVENTION

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

Interventions

CO2 fractional laser DEVICE

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) to treat dyspigmentation in lichen planus pigmentosus

Also known as: SmartXide DEKA DOT

Treatment (CO2 fractional laser) arm

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects, English and non-English speakers, and subjects more than 18 years old
• Histologic diagnosis of LPP affecting the bilateral body
• Willing to refrain from using other topical medications other than the topical medications provided to patients.
• 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
• Willing and able to adhere to the treatment and follow-up schedule as well as post-treatment care

You may not qualify if:

• Patients under 18 years old
• Active skin infection, dermatitis, or a rash on the treatment area
• Pregnant or lactating patients
• Patients on immunosuppressive medications
• Any laser procedures or chemical peel procedures on the affected area within the past 6 months
• Patients with multiple comorbidities such as diabetes mellitus, cardiovascular diseases, neurologic disorders, internal malignancies
• Personal history or family history of forming keloids or hypertrophic scars, or abnormal wound healing
• Patients with known bleeding disorders or taking more than one anticoagulation medications
• Undergoing any surgery in the treatment area within the past 12 months
• History of radiation to the head, neck, and chest area
• Systemic use of isotretinoin within 6 months
• Any use of gold therapy
• Current smoker or history of smoking within 12 months of study
• ny physical or mental condition in which the investigators deem unsafe for the subject to participate in the study.
• History of recurrent herpes simplex on the affected area.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75219, United States

Location

Study Officials

• Heather Goff, MD, MPH

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 27, 2021
• Study Start: August 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 2, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)