M. Hailey-Hailey: hSPCA1 Expression and Skin Structure Upon Laser Therapy
NCT ID: NCT03849989
Last Updated: 2024-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
11 participants
INTERVENTIONAL
2018-12-21
2024-03-15
Brief Summary
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Ablative laser therapy is known to result in a speedy healing of the affected skin site within 2 weeks following laser therapy. The fact that the treated skin site remains clear from this acantholytic disorder in the months/years following ablation, regardless the existence of a germline mutation, suggests that an epigenetic modification occurs in the process of wound healing.
Objective: to (1) study the expression of hSPCA1 in keratinocytes before and after laser therapy and (2) verify the loss of acantholysis by immunohistochemistry and electron microscopy of cell-cell adhesions before and after laser therapy
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Hailey-Hailey disease
Patients with Hailey Hailey, diagnosis confirmed by histopathology or genetics, with therapy resistant skin lesions suitable for ablative lasertherapy.
Skin biopsy specimens will be taken before and after lasertherapy at three time points.
Before treatment:
Affected skin 4 mm punch for immunofluorescence and RNA extraction 2 mm for electron microscopy Healthy skin within same anatomical region 4 mm punch for immunofluorescence and RNA extraction
Immediately after treatment of the treated area:
2 mm punch for histopathology
Six weeks after treatment:
Treated skin 4 mm punch for immunofluorescence and RNA extraction 2 mm for electron microscopy
2mm punch biopsy of clinically uninvolved skin of the upper arm for electron microscopy
Patients without Hailey-Hailey disease:
2mm punch biopsy of skin of the upper arm for electron microscopy
Skin biopsy
Skin biopsy:
Tissue samples will be taken by punch biopsy according to the daily routine of the Department of Dermatology of the Maastricht UMC+.
Steps:
* Skin desinfection with chlorhexidine digluconate 1% solution
* Local anaesthesia with lidocaine hydrochloride 1%
* Biopsy specimens are taken with sterile punch device (disposable biopsy punch delivered by kai medical)
* Biopsy specimens are retrieved with sterile pincer and cut with sterile blade
* Wound is stitched with a single transcutaneous stich using absorbable suture (vicryl 4.0).
* Wound will be treated with R/ fusidic acid ointment 3 to 5 times per day for two weeks
* In the first week after laser therapy the wound will be covered by R/ Urgotull non-adhesive gauze, R/ Cutisoft cotton non-sterile gauze and R/ Klinipress exsupad absorbing bandage.
Interventions
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Skin biopsy
Skin biopsy:
Tissue samples will be taken by punch biopsy according to the daily routine of the Department of Dermatology of the Maastricht UMC+.
Steps:
* Skin desinfection with chlorhexidine digluconate 1% solution
* Local anaesthesia with lidocaine hydrochloride 1%
* Biopsy specimens are taken with sterile punch device (disposable biopsy punch delivered by kai medical)
* Biopsy specimens are retrieved with sterile pincer and cut with sterile blade
* Wound is stitched with a single transcutaneous stich using absorbable suture (vicryl 4.0).
* Wound will be treated with R/ fusidic acid ointment 3 to 5 times per day for two weeks
* In the first week after laser therapy the wound will be covered by R/ Urgotull non-adhesive gauze, R/ Cutisoft cotton non-sterile gauze and R/ Klinipress exsupad absorbing bandage.
Eligibility Criteria
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Inclusion Criteria
* Clinically diagnosed M. Hailey-Hailey as confirmed by histopathology and/or genetic analysis.
* Indication for ablative laser therapy
* \>18 years old
* Informed consent
1.2. Patients without Hailey-Hailey disease
* \>18 years old
* Clinically no symptoms of M. Hailey-Hailey
* Informed consent
Exclusion Criteria
* Treatment with tetracyclines, topical hormones or oral retinoids within the last 30 days preceding participation
* Lack of informed consent
18 Years
ALL
No
Sponsors
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Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Valerie Verstraeten, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center
Locations
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Maastricht University Medical Center
Maastricht, Limburg, Netherlands
Countries
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Related Links
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Hailey-Hailey disease and tight junctions: Claudins 1 and 4 are regulated by ATP2C1 gene encoding Ca(2+) /Mn(2+) ATPase SPCA1 in cultured keratinocytes.
Carbon dioxide laser treatment in Hailey-Hailey disease: a series of 8 patients.
The coexistence of Darier's disease and Hailey-Hailey disease symptoms.
Efficacy of erbium:YAG laser ablation in Darier disease and Hailey-Hailey disease.
Carbon dioxide laser treatment for Hailey-Hailey disease: a retrospective chart review with patient-reported outcomes.
Laser therapy for the treatment of Hailey-Hailey disease: a systematic review with focus on carbon dioxide laser resurfacing.
Other Identifiers
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64815
Identifier Type: -
Identifier Source: org_study_id
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