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Clinical Trials/JPRN-jRCT2052210044
JPRN-jRCT2052210044
Completed
Phase 2

An investigator-initiated clinical trial of a novel skin reconstruction treatment for giant congenital melanocytic nevi using KUPRS-01, a specialized medical device composed of a high hydrostatic-pressure machine and a sealed container. - HP-GIANT

Morimoto Naoki0 sites3 target enrollmentJuly 2, 2021
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ConditionsCongenital giant melanocytic nevus

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Congenital giant melanocytic nevus
Sponsor
Morimoto Naoki
Enrollment
3
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 2, 2021
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Morimoto Naoki

Eligibility Criteria

Inclusion Criteria

  • •1\. Patients with a giant congenital melanocytic nevi which is determined to be unable to be resected with standard treatments including primary closure, tissue expansion, and skin grafting.
  • •2\. Pathological confirmation of the presence of nevus cells in the deep dermis with skin biopsy.
  • •3\. Patients who can undergo surgery under general or local anesthesia.
  • •4\. Patients who are over 6 months of age at the time of consent acquisition.
  • •5\. Patients provided written informed consent for the clinical trial participation.

Exclusion Criteria

  • •1\. Patients with extensive scarring from previous therapies in whom the engraftment of the inactivated nevus is not expected.
  • •2\. Patients receiving systemic immunosuppressants or steroids.
  • •3\. Patients with allergy to penicillin, kanamycin, streptomycin, amphotericin B, or with a history of allergy to penicillin and aminoglycoside antibiotics.
  • •4\. Patients with allergy to cows, mice, or pigs.
  • •5\. Patients with a hystory of malignant skin tumors or with suspected malignant skin tumors.
  • •6\. Patients participating in other clinical trials within the last 3 months.
  • •7\. Patients who had participated in this clinical trial and been transplanted inactivated autologous nevus.
  • •8\. Patients who are judged by the investigators to be inappropriate for participation in this clinical trial.

Outcomes

Primary Outcomes

Not specified

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