Lichen Planus PigmentosusNCT05170308
Fractional CO2 Laser for the Treatment of Lichen Planus Pigmentosus
A study testing CO2 fractional laser in people with Lichen Planus Pigmentosus, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lichen Planus Pigmentosus
- What is being tested?
- CO2 fractional laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
Read the detailed description
Patients with a clinical diagnosis of LPP defined by a skin biopsy will be recruited. Ten patients will be consented. Before the initial visit, all patients will complete a one-month preoperative daily use of SPF 50+ sunscreen. The sun protection is to reduce further sun damage and protect skin from increased photosensitivity that may occur after laser resurfacing. At the initial visit, high resolution photographs of the affected area will be taken. All patients in each group will fill out a form with demographic information. Patients will be instructed to come to their appointment with clean skin and without any lotions or moisturizers on the area. Laser-specific eyewear will be provided to practitioners, patients, and all other people in the treatment room. A blue skin marking pen will be used to draw a line separating the body into two equal halves. Compounded benzocaine, lidocaine, and tetracaine (BLT) cream in a 20:8:4% concentration will be applied to the treatment area for 40 minutes prior to the procedure. Before the treatment, topical anesthesia will be thoroughly washed off with chlorhexidine gluconate and distilled water. One pass with a 1-mm spot density and a 60micron depth will be performed followed by a 1mm spot density and a 200-micron depth will be used. The left half of the testing area will be left intact and used as the control for easy comparison. Forced cold air (Zimmer cooler) will also be used in conjunction with the laser device for better patient comfort.
Cold compresses with refrigerated distilled water can be used to reduce swelling and to soothe the skin with frequent reapplication of white petrolatum to keep the skin coated for days 1-5 post-procedure with strict sun avoidance for the first week post-procedure. Daily use of broad-spectrum sunscreen with SPF50+ will be required after the first week.
Given the current pandemic, limited in-person follow-ups will be scheduled (once at baseline before treatment, then at 12 and 24-weeks post-treatment. Participants will communicate immediate post-treatment issues or concerns along with selfies through MyChart on day 2, 3, 7, 10, 14 to track progress and to identify any post procedural complications in a timely fashion.
There will also be no costs to the patients for the laser procedures as funding will be supplied by the UT Southwestern Dermatology department via an educational grant. Patients desiring treatment of the control side after the study end-point (24 weeks) will be provided at no cost for the participants.
- Conditions
- Lichen Planus Pigmentosus
- Being tested
- CO2 fractional laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 fractional laserDevice
Also called SmartXide DEKA DOT
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 24 weeks post treatment
Secondary outcomes (2)
Overall Subject Satisfaction assessed at 12 weeks post treatment
Overall Subject Satisfaction with improvement of LPP is assessed at 12 weeks post treatment using an 5-point satisfaction and aesthetic scale. Possible scores range from 0-5, where higher scores indicate better outcome.
Measured: 12 weeks post treatment
Overall Subject Satisfaction assessed at 24 weeks post treatment
Overall Subject Satisfaction with improvement of LPP is assessed at 24 weeks post treatment using an 5-point satisfaction and aesthetic scale. Possible scores range from 0-5, where higher scores indicate better outcome.
Measured: 24 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start1 Aug 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: Insufficient patient population to enroll
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lichen Planus PigmentosusStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Woodworth Goff, University of Texas Southwestern Medical Center
- Investigators
- Heather Goff, MD, MPH, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170308
- Sponsor's protocol ID
- STU-2021-0551
- Status last verified
- Jul 2022
- First submitted
- 8 Dec 2021
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional CO2 Laser for the Treatment of Lichen Planus Pigmentosus
- ClinicalTrials.gov ID
- NCT05170308
- Acronym / sponsor ID
- STU-2021-0551
- Conditions
- Lichen Planus Pigmentosus
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient patient population to enroll
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 27 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
Patients with a clinical diagnosis of LPP defined by a skin biopsy will be recruited. Ten patients will be consented. Before the initial visit, all patients will complete a one-month preoperative daily use of SPF 50+ sunscreen. The sun protection is to reduce further sun damage and protect skin from increased photosensitivity that may occur after laser resurfacing. At the initial visit, high resolution photographs of the affected area will be taken. All patients in each group will fill out a form with demographic information. Patients will be instructed to come to their appointment with clean skin and without any lotions or moisturizers on the area. Laser-specific eyewear will be provided to practitioners, patients, and all other people in the treatment room. A blue skin marking pen will be used to draw a line separating the body into two equal halves. Compounded benzocaine, lidocaine, and tetracaine (BLT) cream in a 20:8:4% concentration will be applied to the treatment area for 40 minutes prior to the procedure. Before the treatment, topical anesthesia will be thoroughly washed off with chlorhexidine gluconate and distilled water. One pass with a 1-mm spot density and a 60micron depth will be performed followed by a 1mm spot density and a 200-micron depth will be used. The left half of the testing area will be left intact and used as the control for easy comparison. Forced cold air (Zimmer cooler) will also be used in conjunction with the laser device for better patient comfort.
Cold compresses with refrigerated distilled water can be used to reduce swelling and to soothe the skin with frequent reapplication of white petrolatum to keep the skin coated for days 1-5 post-procedure with strict sun avoidance for the first week post-procedure. Daily use of broad-spectrum sunscreen with SPF50+ will be required after the first week.
Given the current pandemic, limited in-person follow-ups will be scheduled (once at baseline before treatment, then at 12 and 24-weeks post-treatment. Participants will communicate immediate post-treatment issues or concerns along with selfies through MyChart on day 2, 3, 7, 10, 14 to track progress and to identify any post procedural complications in a timely fashion.
There will also be no costs to the patients for the laser procedures as funding will be supplied by the UT Southwestern Dermatology department via an educational grant. Patients desiring treatment of the control side after the study end-point (24 weeks) will be provided at no cost for the participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment (CO2 fractional laser) arm | Other | Device: CO2 fractional laserCO2 fractional laser will be used to treat dyspigmentation in lichen planus pigmentosus in one half along sagittal midline section in each subject. |
| No treatment (Control) arm | No intervention | –One half along sagittal midline section in each subject will not receive the CO2 fractional laser treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO2 fractional laserAlso: SmartXide DEKA DOTThe 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 | Device | Treatment (CO2 fractional laser) arm |
Primary outcome
Improvement in dyspigmentation at 12 weeks post treatment
Time frame: 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).
Improvement in dyspigmentation at 24 weeks post treatment
Time frame: 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).
2 secondary outcomes
Overall Subject Satisfaction assessed at 12 weeks post treatment
Time frame: 12 weeks post treatment
Overall Subject Satisfaction assessed at 24 weeks post treatment
Time frame: 24 weeks post treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Lichen Planus Pigmentosus
Active, not recruiting
Microfocused Ultrasound for Facial Pigmentary Diseases and Rosacea
Melasma, Rosacea
RecruitingPhase 2
The Efficacy of Tranexamic Acid in the Treatment of Lichen Planus Pigmentosus and Erythema Dyschromicum Perstans
Lichen Planus Pigmentosus, Erythema Dyschromicum Perstans
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Goff, MD, MPH principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO2 fractional laser in people with Lichen Planus Pigmentosus, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in dyspigmentation at 12 weeks post treatment (time frame: 12 weeks post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.