Initial Assessment of a Topical Cadexomer Iodine Gel Efficacy on Keloid Scar Revision

NCT03876548 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2019-08-26

No results posted yet for this study

Summary

This is a 6 month, single site, interventional, open label prospective clinical study to evaluate the effects of a cadexomer iodine gel on the prevention of recurrent keloid formation in patients undergoing keloid scar revision.

Conditions

  • Keloid Scar Following Surgery

Interventions

DEVICE

Cadexomer Iodine Gel

Subjects will apply gel product to keloid scar site every other day for 28 days following keloid scar revision surgery.

Sponsors & Collaborators

  • Jacksonville Center For Clinical Research

    collaborator OTHER
  • Next Science TM

    lead INDUSTRY

Principal Investigators

  • Michael Bernhardt, MD · Jacksonville Center For Clinical Research

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-07
Primary Completion
2019-06-30
Completion
2019-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03876548 on ClinicalTrials.gov