Efficacy of Fractional Er:YAG Laser in Lupus Erythematosus Scars

NCT04707924 | Withdrawn

• 1 other identifier: 2020-00987
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Lupus Erythematosus, Cutaneous

Keywords

Lupus; Laser; CO2; Er:YAG

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Cumulative incidence of localized disease flare-up.

  4, 8, 12, 16 and 24 weeks

• Overall average reduction of POSAS scar severity measure.

  16 and 24 weeks

• Overall average scar improvement according to physician global assessment.

  4, 8, 12, 16 and 24 weeks

• Average patient's satisfaction.

  16 and 24 weeks

Other Outcomes (1)

• Proportion of observed side-effects.

  24 weeks

Study Arms (2)

Er:YAG laser

EXPERIMENTAL

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

Device: Er:YAG laser

Control area

NO INTERVENTION

No treatment performed on control areas.

Interventions

Er:YAG laser DEVICE

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

Er:YAG laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent
• Skin type I-IV
• Presence of \>1 scar due to CLE at one localisation
• Stable disease (without or with permanent therapy \>3months)

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of dermatology, University Hospital Inselspital, Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Lupus Erythematosus, Cutaneous

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Kristine Heidemeyer, MD

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 within-subject random allocation

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 13, 2021
• Study Start: June 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)