Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04169438 |
| Other study ID # |
POC-1FLL |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 5, 2019 |
| Est. completion date |
September 29, 2020 |
Study information
| Verified date |
March 2022 |
| Source |
The Center for Clinical and Cosmetic Research |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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. Per
protocol, study team members will investigate the efficacy of applying investigational
product in combination with petrolatum on similar anatomically matched surgical excisions and
bisected sutured wounds for a period of up to 180 days.
Secondary to direct complications that arise from removal of a skin lesion is the aesthetic
disfigurement of tissue repair that results in a scar. The severity of even the most morbid
scars is unpredictable and largely dependent on several variables. It is for this reason that
this pilot study seeks to evaluate the application of a wound care product on both sutured
and un-sutured surgical wounds across all phases of wound healing.
General and widely commercialized self-care (OTC) wound healing products include emollients,
lotions, petrolatum creams, and topical antibiotics. With only a limited number of
investigator-initiated studies, the advancement in this niche medical sector has been
incremental across decades of research. This study is being undertaken to investigate the
safety and effectiveness of a new cream product (FS2-cream) which was initially intended to
manage hyperproliferative closed scars by maintaining an optimal skin environment. To obtain
proof-of-concept results that enable the robust design of subsequent studies, we will obtain
wound care metrics across all phases of healing and make intra-subject comparisons between
the use of FS2-cream + petrolatum and vehicle-cream + petrolatum. We hypothesize that
FS2-cream + petrolatum will show superior clinical outcomes compared to the vehicle control
treatment.
This pilot study is double-blinded, which means that neither the evaluating physician nor the
subject will know which treatment is administered. A separate study team member will
administer the treatment as well as answer questions and discuss any problems throughout the
study.
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.
