An exploratory clinical trial for the congenital melanocytic nevi using the 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 combination therapy with the inactivated autologous nevus tissue by high hydrostatic pressure and the cultured epithelial autograft - The 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-UMIN000030771

Enrollment

Registered

2018-01-15

Start date

2018-02-15

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

Congenital melanocytic nevi

Interventions

Apply cultured epidermal autografts and the pressirized nevus 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 using the existing treatment 2.The hairy nevus or the nevus with nevus cells in its reticular layer 3.Operable patients 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 in previous clinical trials

Design outcomes

Primary

Measure	Time frame
The epithelialization grafted site at 12 weeks after the implantation	—

Secondary

Measure	Time frame
The operability assessment of high hydrostatic pressurization of nevus tissue	—

Countries

Japan

Contacts

Public ContactNaoki Morimoto

Kansai Medical University Department of Plastic and Reconstructive Surgery

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

Outcome results

None listed

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