Wound HealingPhase 2NCT04088357
Efficacy of Topical TolaSure on Acute Induced Wounds in Healthy Participants
A Phase 2 study testing TolaSure Topical Gel in people with Wound Healing, run by BioMendics, LLC at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wound Healing
- What is being tested?
- TolaSure Topical Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Aug 2019to 22 Apr 2020
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Males and Females > 18 years of age
- Health history review
- Physical exam
- Blood and urine clinical chemistries
- Negative pregnancy test
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
J&S Studies
College Station, Texas, 77845
University of Miami
Miami, Florida, 33136
About this study
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
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.
- Conditions
- Wound Healing
- Being tested
- TolaSure Topical Gel, Topical Vehicle Gel
- Keywords
- Healthy Participants, Skin, Dermal, Biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolaSure Topical GelDrug
Also called Active Ingredient BM-3103
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.
Topical Vehicle GelDrug
Also called TolaSure Vehicle Gel
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.
| Study group | Role | What they receive |
|---|---|---|
| 5 Percent TolaSure Topical Gel | Active comparator | 5%(w/w) TolaSure Gel Receives: Drug: TolaSure Topical Gel |
| Topical Vehicle Gel | Placebo comparator | Vehicle Gel Receives: Drug: Topical Vehicle Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1, 2, and 7, then weekly until closure (estimated 8 weeks)
Secondary outcomes (5)
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.
Measured: Week 4
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
Measured: Day 2 and 7, then weekly until wound closure (estimated 8 weeks)
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.
Measured: End of study (estimated 8 weeks)
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)
Measured: Day 1, 2, and 7, then weekly until wound closure (estimated 8 weeks)
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.
Measured: Screening, Day 2 and 7, then weekly until wound closure (estimated 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start26 Aug 2019
- Primary completion22 Apr 2020
- Study completion22 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioMendics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Symbio, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088357
- Sponsor's protocol ID
- SYM 2019-01
- Status last verified
- Jun 2020
- First submitted
- 11 Sep 2019
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04088357
- Acronym / sponsor ID
- SYM 2019-01
- Conditions
- Wound Healing
- Keywords
- Healthy Participants, Skin, Dermal, Biopsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- BioMendics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Symbio, LLC
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 22 Apr 2020 (actual)
- Study completion
- 22 Apr 2020 (actual)
- First posted
- 12 Sep 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5 Percent TolaSure Topical Gel | Active comparator | Drug: TolaSure Topical Gel5%(w/w) TolaSure Gel |
| Topical Vehicle Gel | Placebo comparator | Drug: Topical Vehicle GelVehicle Gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy Males and Females > 18 years of age
- Health history review
- Physical exam
- Blood and urine clinical chemistries
- Negative pregnancy test
Key exclusion criteria (21 listed)
- 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;
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 |
|---|---|---|
| TolaSure Topical GelAlso: Active Ingredient BM-3103TolaSure 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. | Drug | 5 Percent TolaSure Topical Gel |
| Topical Vehicle GelAlso: TolaSure Vehicle GelTolaSure 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. | Drug | Topical Vehicle Gel |
Primary outcome
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.
5 secondary outcomes
Percent Area Reduction after Four Weeks
Time frame: Week 4
Wound Pain Control
Time frame: Day 2 and 7, then weekly until wound closure (estimated 8 weeks)
Quality of Healing
Time frame: End of study (estimated 8 weeks)
Cutaneous Tolerability
Time frame: Day 1, 2, and 7, then weekly until wound closure (estimated 8 weeks)
Blood and Urine Chemistries
Time frame: Screening, Day 2 and 7, then weekly until wound closure (estimated 8 weeks)
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 24 Jun 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TolaSure Topical Gel in people with Wound Healing, run by BioMendics, LLC at 2 sites 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 21 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 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Accelerated Wound Closure (time frame: Day 1, 2, and 7, then weekly until closure (estimated 8 weeks)). 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 24 Jun 2021.