Clinical trial NCT04707924: Efficacy of Fractional Er:YAG Laser in Lupus Erythematosus Scars
Official title: Within-subject, Investigator Initiated, Single-blind, Single-centre, Randomized Clinical Trial Investigating the Efficacy of Fractional Er:YAG Laser in Lupus Erythematosus Scars
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Lupus Erythematosus, Cutaneous
Keywords: Lupus
Laser
CO2
Er:YAG
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 within-subject random allocation
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Average reduction of POSAS scar severity measure.
timeFrame: 24 weeks
Secondary outcomes:
measure: Cumulative incidence of localized disease flare-up.
timeFrame: 4, 8, 12, 16 and 24 weeks
measure: Overall average reduction of POSAS scar severity measure.
timeFrame: 16 and 24 weeks
measure: Overall average scar improvement according to physician global assessment.
timeFrame: 4, 8, 12, 16 and 24 weeks
measure: Average patient's satisfaction.
timeFrame: 16 and 24 weeks
Other outcomes:
measure: Proportion of observed side-effects.
timeFrame: 24 weeks
Locations:
city: Bern
country: Switzerland
facility: Department of dermatology, University Hospital Inselspital, Bern
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Kristine Heidemeyer, MD
role: PRINCIPAL_INVESTIGATOR
References: