None listed
Conditions
Brief summary
This study assesses the efficacy of microneedling in wound healing for patients with recessive dystrophic epidermolysis bullosa. Symmetrical wounds will be measured and randomised to either treatment (microneedling) or placebo (microneedling without needles)
Interventions
micro-needling is a procedure used to stimulate collagen synthesis. It consists of a handheld device with protruding fine needles which pentrate the skin inducing regeneration. Selected wounds will have the microneedling device. This occurs once during the study at baseline. Similar symmetrical wounds will be chosen. One of the pair will be randomised to have the active treatment (microneedling), the other will have the placebo (microneedling device without needles). This will occur at baseline
micro-needling is a procedure used to stimulate collagen synthesis. It consists of a handheld device with protruding fine needles which pentrate the skin inducing regeneration. Selected wounds will have the microneedling device. This occurs once during the study at baseline. Similar symmetrical wounds will be chosen. One of the pair will be randomised to have the active treatment (microneedling), the other will have the placebo (microneedling device without needles). This will occur at baseline and then both wounds will be measured to determine which heals faster. This is not a cross-over trial.
Sponsors
Professor Dedee Murrell
Study design
Allocation
Randomised controlled trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diagnosis of RDEB-HS (patients should have detectable low levels of collagen VII expression and reduced / abnormal anchoring fibrils on electron microscopy). At least 2 symmetric wounds on each side of the body (arms, chest/abdomen, legs) of approximately the same size (at least 4 cm2 as measured accurately by the Visitrak wound measurement system [Smith & Nephew Healthcare Ltd., Hull], difference should not be more than 15%). Ability to sign informed consent, which indicates the investigational nature of this study. Age greater than or equal to 18.
Exclusion criteria
Clinical evidence of local infection of the targeted wound(s). Histopathologic evidence of malignancy (i.e. squamous cell carcinoma - SCC) of the targeted wound(s). Use of systemic or topical steroid therapy within 30 days before enrolment. Use of any investigational drug within the 30 days before enrolment. Patients considered by the investigators to be unreliable or have poor compliance Patients who are pregnant, or who suspect they may be pregnant at the time of the study and lactating women. Women of childbearing age should use effective contraception.
Outcome results
None listed