An exploratory clinical trial for the congenital melanocytic nevi using the noble combination therapy with the inactivated autologous nevus tissue by high hydrostatic pressure and the cultured epithelial autograft
Phase 1
- Conditions
- Melanocytic nevi
- Registration Number
- JPRN-UMIN000020732
- Lead Sponsor
- Department of Plastic and Reconstructive Surgery, Kansai Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Not provided
Exclusion Criteria
1.Patients with scar tissue that prevent the take of inactivated nevus 2.The nevus that has been treated by cultured epidermal autografts already. 3.A history of malignant tumor with disease free interval of 5 years or less 4.Other patients judged by the investigator or sub-investigator to be inappropriate as a subject of this study. 5.Patients who have received this protocol treatments twice.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The take of inactivated nevus with cultured epidermal autograft at 8weeks after implantation
- Secondary Outcome Measures
Name Time Method Adverse events