Efficacy of Fractional Er:YAG Laser in Lupus Erythematosus Scars

September 13, 2021 updated by: University Hospital Inselspital, Berne

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Withdrawn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

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Time Frame: 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.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of localized disease flare-up.
Time Frame: 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.
4, 8, 12, 16 and 24 weeks
Overall average reduction of POSAS scar severity measure.
Time Frame: 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.
16 and 24 weeks
Overall average scar improvement according to physician global assessment.
Time Frame: 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.
4, 8, 12, 16 and 24 weeks
Average patient's satisfaction.
Time Frame: 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.
16 and 24 weeks

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Investigators

  • Principal Investigator: Kristine Heidemeyer, MD, University Hospital Inselspital, Bern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2021

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

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)

September 20, 2021

Last Update Submitted That Met QC Criteria

September 13, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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