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NCT04169438 · ClinicalTrials.gov registry record · NA
Pilot Study Investigating a Restorative Wound Care Cream Together With Petrolatum on Surgical Excisions
A NA study of Wound Heal and Surgical Wound, sponsored by The Center for Clinical and Cosmetic Research.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT04169438: Completed NA study of Wound Heal and Surgical Wound, sponsored by The Center for Clinical and Cosmetic Research.
NCT04169438 is a NA study of Wound Heal and Surgical Wound that has completed, run by The Center for Clinical and Cosmetic Research. The registered enrollment target is 10 participants, below the 119-participant average among 23 other Wound Heal trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04169438, a NA study of Wound Heal and Surgical Wound, has completed, sponsored by The Center for Clinical and Cosmetic Research.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Investigator assessment of target scar or keloid using the Vancouver Scar Scale (VSS). Scale parameters include: Pigmentation (0-2), Vascularity (0-3), Pliability (0-5), and Height (0-3). Scale measurements include: minimum score of 0 = normal to a maximum score of 2, 3 or 5 depending on the parameter measured.
Conditions Studied
Interventions
- OTHER Vehicle Cream Base Emulsion Moisturizer + Petrolatum
- OTHER FS2 Emulsion Moisturizer + Petrolatum
Study Locations (1)
Florida
- The Center for Clinical and Cosmetic Research - Aventura
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-11-05 |
| Est. Completion | 2020-09-29 |
| Phase | NA |
What the finished NCT04169438 record still lists
NCT04169438 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 119-participant average among 23 other Wound Heal trials with a reported enrollment target (92% lower).
The record links to 4 conditions, with Wound Heal appearing as the primary indexed condition, and to 2 interventions - of which Vehicle Cream Base Emulsion Moisturizer + Petrolatum is the first listed.
NCT04169438 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT04169438 about?
NCT04169438 is a clinical study titled "Pilot Study Investigating a Restorative Wound Care Cream Together With Petrolatum on Surgical Excisions". 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 ...
What is the current status of trial NCT04169438?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2019-11-05. Estimated completion is 2020-09-29.
What conditions does trial NCT04169438 study?
This clinical trial studies the following conditions: Wound Heal, Surgical Wound, Scar, Keloid.
What interventions are being tested in trial NCT04169438?
The interventions under investigation include: Vehicle Cream Base Emulsion Moisturizer + Petrolatum (OTHER), FS2 Emulsion Moisturizer + Petrolatum (OTHER).
Who is sponsoring clinical trial NCT04169438?
This trial is sponsored by The Center for Clinical and Cosmetic Research, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04169438 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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