Efficacy of Fractional Er:YAG Laser in Lupus Erythematosus Scars

Lupus Erythematosus, Cutaneous Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04707924
• Other study ID #: 2020-00987
• Status: Withdrawn
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: September 2021
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Cutaneous
• Lupus Erythematosus, Systemic

Intervention

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

Locations

Country	Name	City	State
Switzerland	Department of dermatology, University Hospital Inselspital, Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of observed side-effects.	Proportion of observed treatment side-effects, such as hyperpigmentation and erythema.	24 weeks
Primary	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	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
Secondary	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
Secondary	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
Secondary	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