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Pilot Study Investigating a Restorative Wound Care Cream Together With Petrolatum on Surgical Excisions

NCT04169438 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-03-21

No results posted yet for this study

Summary

The pilot study is prospective, randomized, double-blinded, with intra-subject comparisons against a vehicle control. The primary objective of this pilot study is to investigate the safety and effectiveness of a new wound care product formulated to improve healing outcome, minimize complications of impaired healing and minimize the appearance of scars.

This pilot study is double-blinded, which means that neither the evaluating physician nor the subject will know which treatment is administered.

Subjects' with 2 comparable excision sites will be randomly assigned to use the FS2 restorative wound care product on one excision site and a vehicle formulation of the product on the other. At the discretion of the Principal Investigator, a sutured wound may be bisected for intra-wound comparison of treatments. In all cases, after application of either vehicle or FS2, a layer of petrolatum will be applied to cover the wound site as a standard of care.

Conditions

  • Wound Heal
  • Scar
  • Keloid
  • Surgical Wound

Interventions

OTHER

Vehicle Cream Base Emulsion Moisturizer + Petrolatum

Topical vehicle white (bone) color, oil/water emulsion moisturizer.

OTHER

FS2 Emulsion Moisturizer + Petrolatum

Topical FS2 white (bone) color, oil/water emulsion moisturizer.

Sponsors & Collaborators

  • BirchBioMed Inc.

    collaborator UNKNOWN

  • The Center for Clinical and Cosmetic Research

    lead OTHER

Principal Investigators

  • Mark S Nestor, M.D., Ph.D. · The Center for Clinical and Cosmetic Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-05
Primary Completion
2020-09-29
Completion
2020-09-29

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 NCT04169438 on ClinicalTrials.gov