Lupus Erythematosus, Cutaneous
Conditions
Keywords
Lupus, Laser, CO2, Er:YAG
Brief summary
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.
Interventions
DEVICEEr:YAG laser
Treatment of scars with fractional Er:YAG 2940nm laser.
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
1:1 within-subject random allocation
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average reduction of POSAS scar severity measure. | 24 weeks | Average reduction from baseline of Patient and Observer Scar Assessment Scale (POSAS), ranging from 12 to 120 with higher score indicating a worst condition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of localized disease flare-up. | 4, 8, 12, 16 and 24 weeks | 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. |
| Overall average reduction of POSAS scar severity measure. | 16 and 24 weeks | 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. |
| Overall average scar improvement according to physician global assessment. | 4, 8, 12, 16 and 24 weeks | 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. |
| Average patient's satisfaction. | 16 and 24 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Proportion of observed side-effects. | 24 weeks | Proportion of observed treatment side-effects, such as hyperpigmentation and erythema. |
Countries
Switzerland
Outcome results
None listed