Pilot Study Investigating a Restorative Wound Care Cream Together With Petrolatum on Surgical Excisions
Public ClinicalTrials.gov record NCT04169438. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
"Randomized, Double-blind, Comparative Pilot Study Investigating the Safety and Clinical Efficacy of Applying a Restorative Wound Care Cream Together With Petrolatum on Anatomically Similar Surgical Excisions"
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04169438
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 10 participants
Conditions and interventions
Conditions
Interventions
- Vehicle Cream Base Emulsion Moisturizer + Petrolatum Other
- FS2 Emulsion Moisturizer + Petrolatum Other
Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 5, 2019 (Actual)
- Primary completion
- Sep 29, 2020 (Actual)
- Completion
- Sep 29, 2020 (Actual)
- Last update posted
- Mar 21, 2022
2019 – 2020
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Center for Clinical and Cosmetic Research | Aventura | Florida | 33180 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04169438, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 21, 2022 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04169438 live on ClinicalTrials.gov.