Efficacy of Fractional Er:YAG Laser in Lupus Erythematosus Scars

Insel Gruppe AG, University Hospital Bern

Status: Withdrawn

Conditions: Lupus Erythematosus, Cutaneous

Treatments: Device: Er:YAG laser

Study type: Interventional

Funder types: Other

Identifiers

NCT04707924

2020-00987

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Er:YAG laser

Experimental group

Description:

Treatment of scars with fractional Er:YAG 2940nm laser.

Treatment:

Device: Er:YAG laser

Control area

No Intervention group

Description:

No treatment performed on control areas.