Wound HealNCT04169438
Pilot Study Investigating a Restorative Wound Care Cream Together With Petrolatum on Surgical Excisions
A study testing FS2 Emulsion Moisturizer + Petrolatum in people with Wound Heal and Scar, run by The Center for Clinical and Cosmetic Research at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Heal, Scar, Keloid
- What is being tested?
- FS2 Emulsion Moisturizer + Petrolatum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2019to 29 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- Adult, Senior (>18 years of age)
- Healthy or medically stable
- Requiring surgical removal (excision) of two (2) anatomically significantly similar areas and/or an excision of 3 - 10 cm in length suitable for intra-wound treatment comparison
- Willing and able to follow study requirements
Who cannot join
- Subjects who are medically unstable
- Subjects who are expected to be medically unstable for the duration of the study period and an additional 1-month thereafter
- Pregnant subjects, or those attempting to become pregnant
- Subjects with known immunosuppression or immunosuppressive illness
- Subjects with uncontrolled diabetes or autoimmune disorders
- Subjects with known sensitivity to ingredients in the test-treatment products
- Any other diagnosis, condition, physical or geographical limitation that may render, or increases the likelihood of rendering, the Subject unable to complete the entire study
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
About this study
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"
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.
Read the detailed 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.
- Conditions
- Wound Heal, Scar, Keloid, Surgical Wound
- Being tested
- Vehicle Cream Base Emulsion Moisturizer + Petrolatum, FS2 Emulsion Moisturizer + Petrolatum
- Keywords
- Wound Heal, Scar, Keloid, Surgical Wound
- Medical subject headings
- Cicatrix, Keloid, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vehicle Cream Base Emulsion Moisturizer + PetrolatumOther
Topical vehicle white (bone) color, oil/water emulsion moisturizer.
FS2 Emulsion Moisturizer + PetrolatumOther
Topical FS2 white (bone) color, oil/water emulsion moisturizer.
| Study group | Role | What they receive |
|---|---|---|
| Vehicle Cream Base Emulsion Moisturizer + Petrolatum | Placebo comparator | Vehicle Cream Base Emulsion Moisturizer + Petrolatum Receives: Other: Vehicle Cream Base Emulsion Moisturizer + Petrolatum |
| FS2 Emulsion Moisturizer + Petrolatum | Experimental | FS2 Emulsion Moisturizer + Petrolatum Receives: Other: FS2 Emulsion Moisturizer + Petrolatum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vancouver Scar Scale (VSS)
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.
Measured: 180 Days
Patient and Observer Scar Assessment Scale (POSAS)
Investigator assessment of target scar or keloid using the Patient and Observer Scar Assessment Scale (POSAS). Scale parameters include: Vascularity, Pigmentation, Thickness, Relief, Pliability, and Surface Area. Scale measurements include: minimum score of 1 = normal skin to a maximum score of 10 = worst scar imaginable.
Measured: 180 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start5 Nov 2019
- Primary completion29 Sep 2020
- Study completion29 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study consists of two (2) Treatments, both of which are administered in combination with petrolatum. The Treatments consist of either a restorative wound care cream (FS2 ingredient) or a vehicle wound care cream (without the FS2 ingredient).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Center for Clinical and Cosmetic Research
- Sponsor type
- University, hospital or other
- Collaborators
- BirchBioMed Inc.
- Responsible party
- Principal investigator, Mark Steven Nestor, M.D., Ph.D., The Center for Clinical and Cosmetic Research
- Investigators
- Mark S Nestor, M.D., Ph.D., Principal investigator, The Center for Clinical and Cosmetic Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169438
- Sponsor's protocol ID
- POC-1FLL
- Status last verified
- Mar 2022
- First submitted
- 15 Nov 2019
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT04169438
- Acronym / sponsor ID
- POC-1FLL
- Conditions
- Wound Heal, Scar, Keloid, Surgical Wound
- Keywords
- Wound Heal, Scar, Keloid, Surgical Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The Center for Clinical and Cosmetic ResearchUniversity, hospital or other
- Collaborators
- BirchBioMed Inc.
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 29 Sep 2020 (actual)
- Study completion
- 29 Sep 2020 (actual)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study consists of two (2) Treatments, both of which are administered in combination with petrolatum. The Treatments consist of either a restorative wound care cream (FS2 ingredient) or a vehicle wound care cream (without the FS2 ingredient).
| Arm | Type | Receives |
|---|---|---|
| Vehicle Cream Base Emulsion Moisturizer + Petrolatum | Placebo comparator | Other: Vehicle Cream Base Emulsion Moisturizer + PetrolatumVehicle Cream Base Emulsion Moisturizer + Petrolatum |
| FS2 Emulsion Moisturizer + Petrolatum | Experimental | Other: FS2 Emulsion Moisturizer + PetrolatumFS2 Emulsion Moisturizer + Petrolatum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female
- Adult, Senior (>18 years of age)
- Healthy or medically stable
- Requiring surgical removal (excision) of two (2) anatomically significantly similar areas and/or an excision of 3 - 10 cm in length suitable for intra-wound treatment comparison
- Willing and able to follow study requirements
Key exclusion criteria (7 listed)
- Subjects who are medically unstable
- Subjects who are expected to be medically unstable for the duration of the study period and an additional 1-month thereafter
- Pregnant subjects, or those attempting to become pregnant
- Subjects with known immunosuppression or immunosuppressive illness
- Subjects with uncontrolled diabetes or autoimmune disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vehicle Cream Base Emulsion Moisturizer + PetrolatumTopical vehicle white (bone) color, oil/water emulsion moisturizer. | Other | Vehicle Cream Base Emulsion Moisturizer + Petrolatum |
| FS2 Emulsion Moisturizer + PetrolatumTopical FS2 white (bone) color, oil/water emulsion moisturizer. | Other | FS2 Emulsion Moisturizer + Petrolatum |
Primary outcome
Vancouver Scar Scale (VSS)
Time frame: 180 Days
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.
Patient and Observer Scar Assessment Scale (POSAS)
Time frame: 180 Days
Investigator assessment of target scar or keloid using the Patient and Observer Scar Assessment Scale (POSAS). Scale parameters include: Vascularity, Pigmentation, Thickness, Relief, Pliability, and Surface Area. Scale measurements include: minimum score of 1 = normal skin to a maximum score of 10 = worst scar imaginable.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- BirchBioMed Inc.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark S Nestor, M.D., Ph.D. principal investigator
The Center for Clinical and Cosmetic Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FS2 Emulsion Moisturizer + Petrolatum in people with Wound Heal and Scar, run by The Center for Clinical and Cosmetic Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vancouver Scar Scale (VSS) (time frame: 180 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022.