Pilot Study Investigating a Restorative Wound Care Cream Together With Petrolatum on Surgical Excisions

NCT04169438 | Completed

• 1 other identifier: POC-1FLL
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Wound Heal; Scar; Keloid; Surgical Wound

Keywords

Wound Heal; Scar; Keloid; Surgical Wound

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Vehicle Cream Base Emulsion Moisturizer + Petrolatum

PLACEBO COMPARATOR

Vehicle Cream Base Emulsion Moisturizer + Petrolatum

Other: Vehicle Cream Base Emulsion Moisturizer + Petrolatum

FS2 Emulsion Moisturizer + Petrolatum

EXPERIMENTAL

FS2 Emulsion Moisturizer + Petrolatum

Other: FS2 Emulsion Moisturizer + Petrolatum

Interventions

Vehicle Cream Base Emulsion Moisturizer + Petrolatum OTHER

Topical vehicle white (bone) color, oil/water emulsion moisturizer.

Vehicle Cream Base Emulsion Moisturizer + Petrolatum

FS2 Emulsion Moisturizer + Petrolatum OTHER

Topical FS2 white (bone) color, oil/water emulsion moisturizer.

FS2 Emulsion Moisturizer + Petrolatum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Center for Clinical and Cosmetic Research: lead
• BirchBioMed Inc.: collaborator

Study Sites (1)

The Center for Clinical and Cosmetic Research

Aventura, Florida, 33180, United States

Location

Related Links

• BirchBioMed Inc.

MeSH Terms

Conditions

Cicatrix; Keloid; Surgical Wound

Interventions

Petrolatum

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hydrocarbons; Organic Chemicals

Study Officials

• Mark S Nestor, M.D., Ph.D.

  The Center for Clinical and Cosmetic Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: 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).

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 19, 2019
• Study Start: November 5, 2019
• Primary Completion: September 29, 2020
• Study Completion: September 29, 2020
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)