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Efficacy of Topical TolaSure on Acute Induced Wounds in Healthy Participants

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ClinicalTrials.gov Identifier: NCT04088357
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
Symbio, LLC
Information provided by (Responsible Party):
BioMendics, LLC

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.

Condition or disease Intervention/treatment Phase
Wound Healing Drug: TolaSure Topical Gel Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 26, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 5 Percent TolaSure Topical Gel
5%(w/w) TolaSure Gel
Drug: TolaSure Topical Gel
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.
Other Name: Active Ingredient BM-3103

Placebo Comparator: Topical Vehicle Gel
Vehicle Gel
Drug: TolaSure Topical Gel
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.
Other Name: Active Ingredient BM-3103




Primary Outcome Measures :
  1. Accelerated Wound Closure [ Time Frame: Day 1, 2, and 7, then weekly until closure (estimated 8 weeks) ]
    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 :
  1. Percent Area Reduction after Four Weeks [ Time Frame: Week 4 ]
    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.

  2. Wound Pain Control [ Time Frame: Day 2 and 7, then weekly until wound closure (estimated 8 weeks) ]

    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


  3. Quality of Healing [ Time Frame: End of study (estimated 8 weeks) ]
    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.

  4. Cutaneous Tolerability [ Time Frame: Day 1, 2, and 7, then weekly until wound closure (estimated 8 weeks) ]

    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)


  5. Blood and Urine Chemistries [ Time Frame: Screening, Day 2 and 7, then weekly until wound closure (estimated 8 weeks) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04088357


Contacts
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Contact: Karen McGuire, PhD 3306512140 info@biomendics.com

Locations
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United States, Florida
University of Miami Not yet recruiting
Miami, Florida, United States, 33136
Contact: Leigh Nattkemper, PhD    305-588-9734    lxn202@med.miami.edu   
Contact: Aliette Espinosa, CCRP    305-689-3376    a.espinosa2@med.miami.edu   
Principal Investigator: Robert Kirsner, MD         
United States, Texas
J&S Studies Recruiting
College Station, Texas, United States, 77845
Contact: Jeremy Scott    979-774-5933    jscott@js-studies.com   
Principal Investigator: Terry Jones, MD         
Sponsors and Collaborators
BioMendics, LLC
Symbio, LLC

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Responsible Party: BioMendics, LLC
ClinicalTrials.gov Identifier: NCT04088357     History of Changes
Other Study ID Numbers: SYM 2019-01
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BioMendics, LLC:
Healthy Participants
Skin
Dermal
Biopsy
Additional relevant MeSH terms:
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Wounds and Injuries