Wound HealingPhase 1NCT03620175
Safety and Efficacy of Topical TolaSure on Skin Punch Biopsies in Healthy Participants
A Phase 1 study testing TolaSure Topical Gel in people with Wound Healing, run by BioMendics, LLC at 1 site in United States.
Trial summary
TolaSure is a topical gel for the promotion of wound healing. This phase I study will assess the safety, tolerability and clinical effect of TolaSure when applied to skin wounds created by punch biopsy in healthy participants. 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
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2018to 12 Dec 2018
- Phase
- Phase 1
- 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
- Pregnancy test
- Drug screen
Who cannot join
- Acute or chronic skin disorders (e.g. acne, psoriasis, dermatitis)
- Prone to keloids or hypertrophic scarring
- Topical or systemic antibiotics within 4 weeks of study enrollment
- Subjects with mental illnesses
- Diagnosed with Diabetes Type I/II
- Surgery within the previous 3 months (except for minor cosmetic or dental procedures)
Show all 19Show fewer
- 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
- Cancer diagnosis in the last year
- 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
1 site in 1 country.
About this study
Official title: A Phase One, Single Center, Open-Label, University of Miami Medical Center, 14 Day Study Evaluating the Safety, Cutaneous Tolerability, and Efficacy of TolaSure Topical Gel in Healthy Volunteers
TolaSure is a topical gel for the promotion of wound healing. This phase I study will assess the safety, tolerability and clinical effect of TolaSure when applied to skin wounds created by punch biopsy in healthy participants. A total of 26 healthy volunteers, males and females ages 18 years or older, will be enrolled. Subjects will monitored for safety and efficacy over the course of 2 weeks following daily topical administration of TolaSure.
- Conditions
- Wound Healing
- Being tested
- TolaSure Topical 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
TolaSure topical gel is applied to skin punch biopsies daily over the course of 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 5 Percent TolaSure Topical Gel | Active comparator | Not described Receives: Drug: TolaSure Topical Gel |
| 1.5 Percent TolaSure Topical Gel | Active comparator | Not described Receives: Drug: TolaSure Topical Gel |
| 0.5 Percent TolaSure Topical Gel | Active comparator | Not described Receives: Drug: TolaSure Topical Gel |
| Topical Vehicle Gel | Placebo comparator | Not described Receives: Drug: TolaSure Topical Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Day 1, 2, 7 and 14.
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, 7 and 14.
Secondary outcomes (1)
Wound Closure
Imaging of punch biopsies to monitor for healing and wound closure including measurement of changes in wound area (mm^2) over time will be assessed using digital imaging and analyzed using wound tracing techniques followed by the use of appropriate statistics.
Measured: Day 1, 2, 7 and 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start16 Jul 2018
- Primary completion12 Dec 2018
- Study completion12 Dec 2018
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Each patient receives each of the 4 treatment arms. It is closest to a single-subject design where each participant serves as their own control. The placement of treatments on each of the 4 wounds is randomized and assessed by a blinded outcomes assessor.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioMendics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Miami
- Responsible party
- Sponsor
- Investigators
- Karen McGuire, PhD, Study director, BioMendics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620175
- Sponsor's protocol ID
- 20180394
- Status last verified
- Jan 2019
- First submitted
- 10 Jul 2018
- Last updated
- 30 Jan 2019
- 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 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase One, Single Center, Open-Label, University of Miami Medical Center, 14 Day Study Evaluating the Safety, Cutaneous Tolerability, and Efficacy of TolaSure Topical Gel in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03620175
- Acronym / sponsor ID
- 20180394
- Conditions
- Wound Healing
- Keywords
- Healthy Participants, Skin, Dermal, Biopsy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- BioMendics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Miami
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 12 Dec 2018 (actual)
- First posted
- 8 Aug 2018 (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 wound healing. This phase I study will assess the safety, tolerability and clinical effect of TolaSure when applied to skin wounds created by punch biopsy in healthy participants. A total of 26 healthy volunteers, males and females ages 18 years or older, will be enrolled. Subjects will monitored for safety and efficacy over the course of 2 weeks following daily topical administration of TolaSure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Each patient receives each of the 4 treatment arms. It is closest to a single-subject design where each participant serves as their own control. The placement of treatments on each of the 4 wounds is randomized and assessed by a blinded outcomes assessor.
| Arm | Type | Receives |
|---|---|---|
| 5 Percent TolaSure Topical Gel | Active comparator | Drug: TolaSure Topical Gel |
| 1.5 Percent TolaSure Topical Gel | Active comparator | Drug: TolaSure Topical Gel |
| 0.5 Percent TolaSure Topical Gel | Active comparator | Drug: TolaSure Topical Gel |
| Topical Vehicle Gel | Placebo comparator | Drug: TolaSure Topical Gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy Males and Females > 18 years of age
- Health history review
- Physical exam
- Blood and urine clinical chemistries
- Pregnancy test
Key exclusion criteria (19 listed)
- Acute or chronic skin disorders (e.g. acne, psoriasis, dermatitis)
- Prone to keloids or hypertrophic scarring
- Topical or systemic antibiotics within 4 weeks of study enrollment
- Subjects with mental illnesses
- Diagnosed with Diabetes Type I/II
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 GelTolaSure topical gel is applied to skin punch biopsies daily over the course of 2 weeks. | Drug | 0.5 Percent TolaSure Topical Gel, 1.5 Percent TolaSure Topical Gel, 5 Percent TolaSure Topical Gel, Topical Vehicle Gel |
Primary outcome
Blood and Urine Chemistries
Time frame: Day 1, 2, 7 and 14.
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.
Cutaneous Tolerability
Time frame: Day 1, 2, 7 and 14.
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)
1 secondary outcome
Wound Closure
Time frame: Day 1, 2, 7 and 14.
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 30 Jan 2019.
- 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.
Karen McGuire, PhD study director
BioMendics, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TolaSure Topical Gel in people with Wound Healing, run by BioMendics, LLC at 1 site 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 6 inclusion and 19 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 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Blood and Urine Chemistries (time frame: Day 1, 2, 7 and 14.). The study lists 2 primary outcomes in all. 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 30 Jan 2019.