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Efficacy of Topical TolaSure on Acute Induced Wounds in Healthy Participants

Primary Purpose

Wound Healing

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TolaSure Topical Gel
Topical Vehicle Gel
Sponsored by
BioMendics, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Healing focused on measuring Healthy Participants, Skin, Dermal, Biopsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy Males and Females > 18 years of age
  • Health history review
  • Physical exam
  • Blood and urine clinical chemistries
  • Negative pregnancy test

Exclusion Criteria:

  • Acute or chronic skin disorders (e.g. psoriasis);
  • Acne or dermatitis at the test site;
  • Prone to keloids or hypertrophic scarring;
  • Topical or systemic antibiotics within 4 weeks of study enrollment;
  • Subjects with known severe mental illness which, in the investigator's opinion, may prevent informed consent or interfere with the subject's ability to comply with study protocol procedures;
  • Diagnosed with Diabetes Type I/II or glucose results indicative of prediabetic condition;
  • Morbidly obese with a Body Mass Index (BMI) ≥ 40;
  • Surgery within the previous 3 months (except for minor cosmetic or dental procedures)
  • History of severe vitamin or mineral deficiency;
  • History of drug or alcohol abuse (as defined by the Investigator);
  • Smoking/Vaping;
  • HIV/AIDS;
  • Consistently taking steroids and/or non-steroidal anti-inflammatory drugs. Subjects may use NSAIDs on an as needed basis with no more than 7 days of consecutive use;
  • Cancer diagnosis in the last 5 years;
  • Currently receiving chemotherapy or radiation;
  • Women who are pregnant, nursing, or planning a pregnancy;
  • Hyper- or hypo-pigmentation, or tattoos in the area where they will place the test fields;
  • Symptoms of a clinically significant illness in the four weeks before treatment application that may influence the outcome of the study;
  • Treatment with any investigational agent within one month before treatment application for this trial;
  • Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's return for follow-up visits on schedule;
  • Other unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for enrollment.

Sites / Locations

  • University of Miami
  • J&S Studies

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

5 Percent TolaSure Topical Gel

Topical Vehicle Gel

Arm Description

5%(w/w) TolaSure Gel

Vehicle Gel

Outcomes

Primary Outcome Measures

Accelerated Wound Closure
Time-to-closure will be calculated by the number of days from biopsy to wound closure. Wound closure (changes in wound area (mm^2) over time) will be determined by the digital imaging platform software with Principal Investigator confirmation.

Secondary Outcome Measures

Percent Area Reduction after Four Weeks
Wound area measurements (mm^2) will be calculated at week 4 by using a digital imaging. A percent reduction in area at week 4 will be calculated by comparing the initial area of the biopsy at Day 1 to the week 4 biopsy area.
Wound Pain Control
Wound-related pain or discomfort will be assessed, using the Visual Analog Scale (VAS) for Pain, for each individual wound site as pain at rest followed by pain to touch. The VAS Pain is a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length. Pain will be defined per the following scale: None - 0-4 mm; Mild - 5-44 mm: Moderate - 45-74; Severe - 75-100 mm
Quality of Healing
Patient and Observer Scar Assessment Scale (POSAS) version 2.0 will be used to assess the quality of healing of each biopsy site at the end of the study once both wounds are closed.
Cutaneous Tolerability
Cutaneous tolerability will include an evaluation of erythema and edema following the modified Draize scoring system. Draize scores will be recorded and changes from baseline Draize scores will be monitored over the course of the time frame. Draize Scoring System. Erythema: 0-No Erythema, 1-Slight Erythema, 2-Well Defined Erythema, 3- Moderate or Severe Erythema, 4- Severe Erythema or slight eschar formation. Edema: 0- No Edema, 1- Very Slight Edema(barely perceptible), 2-Slight Edema (well defined edges), 3-Moderate Edema (raised >1mm), 4- Severe Edema (raised >1mm and extending beyond the area of exposure)
Blood and Urine Chemistries
Absolute values and changes over time of clinical chemistries including; Absolute values and changes over time of clinical blood and urine chemistries including; Hematology and Coagulation, Coagulation, Serum Chemistry, and Urinalysis. Blood and urine analytes are measured on a per mL basis.

Full Information

First Posted
September 11, 2019
Last Updated
June 18, 2021
Sponsor
BioMendics, LLC
Collaborators
Symbio, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04088357
Brief Title
Efficacy of Topical TolaSure on Acute Induced Wounds in Healthy Participants
Official Title
A Phase II, Closed Label, Randomized, Double Blind Study for the Treatment of Acute Induced Wounds With TolaSure Gel, 5% w/w in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 26, 2019 (Actual)
Primary Completion Date
April 22, 2020 (Actual)
Study Completion Date
April 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioMendics, LLC
Collaborators
Symbio, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
TolaSure is a topical gel for the promotion of accelerated wound healing. This phase II study will primarily assess the efficacy of TolaSure when applied to skin wounds created by punch biopsy in healthy participants. Safety, cutaneous tolerability, wound pain control, and quality of healing will also be assessed. A total of 80 healthy volunteers, males and females ages 18 years or older, will be enrolled. Subjects will be monitored for safety and efficacy until wound closure (estimation about 8 weeks) following topical administration of TolaSure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Healing
Keywords
Healthy Participants, Skin, Dermal, Biopsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5 Percent TolaSure Topical Gel
Arm Type
Active Comparator
Arm Description
5%(w/w) TolaSure Gel
Arm Title
Topical Vehicle Gel
Arm Type
Placebo Comparator
Arm Description
Vehicle Gel
Intervention Type
Drug
Intervention Name(s)
TolaSure Topical Gel
Other Intervention Name(s)
Active Ingredient BM-3103
Intervention Description
TolaSure topical gel is applied to skin punch biopsies daily for the first seven consecutive days, then three times a week, defined as every two to three days, until closure.
Intervention Type
Drug
Intervention Name(s)
Topical Vehicle Gel
Other Intervention Name(s)
TolaSure Vehicle Gel
Intervention Description
TolaSure Vehicle Gel is applied topically to skin punch biopsies daily for the first seven consecutive days, then three times a week, defined as every two to three days, until closure.
Primary Outcome Measure Information:
Title
Accelerated Wound Closure
Description
Time-to-closure will be calculated by the number of days from biopsy to wound closure. Wound closure (changes in wound area (mm^2) over time) will be determined by the digital imaging platform software with Principal Investigator confirmation.
Time Frame
Day 1, 2, and 7, then weekly until closure (estimated 8 weeks)
Secondary Outcome Measure Information:
Title
Percent Area Reduction after Four Weeks
Description
Wound area measurements (mm^2) will be calculated at week 4 by using a digital imaging. A percent reduction in area at week 4 will be calculated by comparing the initial area of the biopsy at Day 1 to the week 4 biopsy area.
Time Frame
Week 4
Title
Wound Pain Control
Description
Wound-related pain or discomfort will be assessed, using the Visual Analog Scale (VAS) for Pain, for each individual wound site as pain at rest followed by pain to touch. The VAS Pain is a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length. Pain will be defined per the following scale: None - 0-4 mm; Mild - 5-44 mm: Moderate - 45-74; Severe - 75-100 mm
Time Frame
Day 2 and 7, then weekly until wound closure (estimated 8 weeks)
Title
Quality of Healing
Description
Patient and Observer Scar Assessment Scale (POSAS) version 2.0 will be used to assess the quality of healing of each biopsy site at the end of the study once both wounds are closed.
Time Frame
End of study (estimated 8 weeks)
Title
Cutaneous Tolerability
Description
Cutaneous tolerability will include an evaluation of erythema and edema following the modified Draize scoring system. Draize scores will be recorded and changes from baseline Draize scores will be monitored over the course of the time frame. Draize Scoring System. Erythema: 0-No Erythema, 1-Slight Erythema, 2-Well Defined Erythema, 3- Moderate or Severe Erythema, 4- Severe Erythema or slight eschar formation. Edema: 0- No Edema, 1- Very Slight Edema(barely perceptible), 2-Slight Edema (well defined edges), 3-Moderate Edema (raised >1mm), 4- Severe Edema (raised >1mm and extending beyond the area of exposure)
Time Frame
Day 1, 2, and 7, then weekly until wound closure (estimated 8 weeks)
Title
Blood and Urine Chemistries
Description
Absolute values and changes over time of clinical chemistries including; Absolute values and changes over time of clinical blood and urine chemistries including; Hematology and Coagulation, Coagulation, Serum Chemistry, and Urinalysis. Blood and urine analytes are measured on a per mL basis.
Time Frame
Screening, Day 2 and 7, then weekly until wound closure (estimated 8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy Males and Females > 18 years of age Health history review Physical exam Blood and urine clinical chemistries Negative pregnancy test Exclusion Criteria: Acute or chronic skin disorders (e.g. psoriasis); Acne or dermatitis at the test site; Prone to keloids or hypertrophic scarring; Topical or systemic antibiotics within 4 weeks of study enrollment; Subjects with known severe mental illness which, in the investigator's opinion, may prevent informed consent or interfere with the subject's ability to comply with study protocol procedures; Diagnosed with Diabetes Type I/II or glucose results indicative of prediabetic condition; Morbidly obese with a Body Mass Index (BMI) ≥ 40; Surgery within the previous 3 months (except for minor cosmetic or dental procedures) History of severe vitamin or mineral deficiency; History of drug or alcohol abuse (as defined by the Investigator); Smoking/Vaping; HIV/AIDS; Consistently taking steroids and/or non-steroidal anti-inflammatory drugs. Subjects may use NSAIDs on an as needed basis with no more than 7 days of consecutive use; Cancer diagnosis in the last 5 years; Currently receiving chemotherapy or radiation; Women who are pregnant, nursing, or planning a pregnancy; Hyper- or hypo-pigmentation, or tattoos in the area where they will place the test fields; Symptoms of a clinically significant illness in the four weeks before treatment application that may influence the outcome of the study; Treatment with any investigational agent within one month before treatment application for this trial; Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's return for follow-up visits on schedule; Other unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for enrollment.
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
J&S Studies
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Topical TolaSure on Acute Induced Wounds in Healthy Participants

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