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Pilot Study Investigating a Restorative Wound Care Cream Together With Petrolatum on Surgical Excisions
NCT04169438 · View on ClinicalTrials.gov ↗
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 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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04169438
The ClinicalTrials.gov registry entry for NCT04169438 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Center for Clinical and Cosmetic Research, which has 35 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04169438 reports 1 study location spanning 1 distinct geographic area — top geographies include Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04169438?
This trial is sponsored by The Center for Clinical and Cosmetic Research, which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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