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| Name | Class |
|---|---|
| BirchBioMed Inc. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vehicle Cream Base Emulsion Moisturizer + Petrolatum | Placebo Comparator | Vehicle Cream Base Emulsion Moisturizer + Petrolatum |
|
| FS2 Emulsion Moisturizer + Petrolatum | Experimental | FS2 Emulsion Moisturizer + Petrolatum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vehicle Cream Base Emulsion Moisturizer + Petrolatum | Other | Topical vehicle white (bone) color, oil/water emulsion moisturizer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 180 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark S Nestor, M.D., Ph.D. | The Center for Clinical and Cosmetic Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center for Clinical and Cosmetic Research | Aventura | Florida | 33180 | United States |
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| Label | URL |
|---|---|
| BirchBioMed Inc. | View source |
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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).
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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.
| FS2 Emulsion Moisturizer + Petrolatum | Other | Topical FS2 white (bone) color, oil/water emulsion moisturizer. |
|
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D007627 | Keloid |
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D010577 | Petrolatum |
| ID | Term |
|---|---|
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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