Efficacy of Fractional Er:YAG Laser in Lupus Erythematosus Scars

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Lupus Erythematosus, Cutaneous
• Intervention / Treatment: Device: Er:YAG laser

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Department of dermatology, University Hospital Inselspital, Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Er:YAG laser; Treatment of scars with fractional Er:YAG 2940nm laser.	Device: Er:YAG laser; Treatment of scars with fractional Er:YAG 2940nm laser.
No Intervention: Control area; No treatment performed on control areas.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of observed side-effects.	Proportion of observed treatment side-effects, such as hyperpigmentation and erythema.	24 weeks

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Kristine Heidemeyer, MD, University Hospital Inselspital, Bern

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Estimated): December 1, 2022
• Study Completion (Estimated): December 1, 2022

Study Registration Dates

• First Submitted: January 11, 2021
• First Submitted That Met QC Criteria: January 11, 2021
• First Posted (Actual): January 13, 2021

Study Record Updates

• Last Update Posted (Actual): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Lupus; Er:YAG; Laser; CO2
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases; Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous
• Other Study ID Numbers: 2020-00987

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No