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

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 - The noble combination therapy with the inactivated nevus tissue by high hydrostatic pressure and the cultured epithelial autograft

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020732

Enrollment

Registered

2016-01-26

Start date

2016-02-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanocytic nevi

Interventions

Apply cultured epidermal autografts on the pressirized nevusApply on the wound after the removal of the nevus

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients with congenital pigmented nevus that can not be excised and sutured primarily 2.The area of the nevus is more than 0.25% of the body surface area 3.Operable patients more than 7 months old and 4.Written informed consent

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
The take of inactivated nevus with cultured epidermal autograft at 8weeks after implantation	—

Secondary

Measure	Time frame
Adverse events	—

Countries

Japan

Contacts

Public ContactOmura Miyuki

Kansai Medical University Center for Clinical Research

kmuccr@hirakata.kmu.ac.jp072-804-0101

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026