Efficacy of Fractional Er:YAG Laser in Lupus Erythematosus Scars

Study Overview
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Brief Summary
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Cutaneous Lupus erythematosus (CLE) is a chronic autoimmune connective tissue disease with a prevalence of 14.6 - 73.2/100,000, predominantly in women in mid adulthood. Cutaneous lesions occur in about 75-80% of patients with systemic lupus erythematodes.These lesions unfortunately and invariably lead to significant scarring and postinflammatory hypo- and hyperpigmentation. Several studies have reported that laser treatments in patients with CLE have a positive effect and safety. However, only few case reports exist about the effect of ablative lasers such as Carbon Dioxide (CO2) and Erbium-doped Yttrium Aluminum Garnet (Er:YAG) lasers in CLE scarring. Although no study shows a flare-up of CLE after laser treatment of the scars, many physicians are afraid of treating these often stigmatizing scars. Considering the huge psychological impact of facial scaring on quality of life, it is essential to explore and assess the value of already well-established treatment options for the management of scars also in patients with cutaneous lupus erythematodes. Hereby the study seeks the subjective and objective improvement of the CLE-scars after treatment with fractional Er:YAG laser compared to control (untreated) areas.

Official Title
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Within-subject, Investigator Initiated, Single-blind, Single-centre, Randomized Clinical Trial Investigating the Efficacy of Fractional Er:YAG Laser in Lupus Erythematosus Scars

Conditions
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Lupus Erythematosus, Cutaneous

Intervention / Treatment
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* Device: Er:YAG laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent Skin type I-IV Presence of >1 scar due to CLE at one localisation Stable disease (without or with permanent therapy >3months) Exclusion Criteria: History of adverse events related to ablative fractional laser therapy Ablative resurfacing within the last 6 months on the scar Pregnant or breast feeding women Intake of isotretinoin in the last 6 month Intention to become pregnant during the course of the study Any scar treatment in the last 3 month before inclusion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 within-subject random allocation
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Er:YAG laser<br>Treatment of scars with fractional Er:YAG 2940nm laser. | Device: Er:YAG laser<br>* Treatment of scars with fractional Er:YAG 2940nm laser.<br>|
| No Intervention: Control area<br>No treatment performed on control areas. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average reduction of POSAS scar severity measure. | Average reduction from baseline of Patient and Observer Scar Assessment Scale (POSAS), ranging from 12 to 120 with higher score indicating a worst condition. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of localized disease flare-up. | Cumulative incidence of disease flare-up defined according to localized Revised Cutaneous Lupus Erythematosus Disease Area and Severity Index (RCLASI) difference from baseline of 1 point or above. The localized RCLASI ranges from 0 to 13, with higher scores indicating a worst local disease activity. | 4, 8, 12, 16 and 24 weeks | 
| Overall average reduction of POSAS scar severity measure. | Overall average reduction from baseline of Patient and Observer Scar Assessment Scale (POSAS), ranging from 12 to 120 with higher score indicating a worst condition. | 16 and 24 weeks | 
| Overall average scar improvement according to physician global assessment. | Overall average scar improvement from baseline according to a 6-point Physician Global Assessment (PGA) scale, based on before-after pictures of lesions assessment, ranging from 1 to 6, with higher scores indicating a better outcome. | 4, 8, 12, 16 and 24 weeks | 
| Average patient's satisfaction. | Average patient's satisfaction score as assessed by a 9-point anchored visual analogue scale (VAS), ranging from -4 to +4, with negative scores indicating a worsening of condition compared to the untreated control scar, with 0 indicating no difference and with positive scores indicating an improvement. | 16 and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lupus, Laser, CO2, Er:YAG