Investigation of micro-needling skin therapy for recessive dystrophic epidermolysis bullosa (RDEB) in Australia

Not Applicable

Recruiting

• Conditions: [Recessive dystrophic epidermolysis bullosa]; Skin - Dermatological conditions

• Registration Number: ACTRN12611000668909
• Lead Sponsor: Professor Dedee Murrell

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
median healing time of lesions for each treatment group- assessed by the Visitrak machine[assessed at regular time intervals and at 12 months.]

Secondary Outcome Measures

Name	Time	Method
Percent change in size of wounds for each treatment group- assessed by the Visitrak machine[assessed at regular time intervals and at 12 months.];Change in appearance score (VAS) of wounds for each treatment group as assessed by investigator and patient[assessed at regular time intervals and at 12 months.];Change in pain score (VAS) of wounds for each treatment group[assessed at regular time intervals and at 12 months];Change in pruritus score (VAS) of wounds for each treatment group[assessed at regular time intervals and at 12 months]