A Phase 2 interventional study of 5% TolaSure Topical Gel and Topical Placebo Gel in Epidermolysis Bullosa Simplex, sponsored by BioMendics, LLC. Recruiting at 2 sites in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by BioMendics, LLC · Phase 2, Interventional, and Treatment
This Phase II clinical study will assess the efficacy, safety and tolerability of topical TolaSure Gel in adults and pediatric patients (2 years of age and older) diagnosed with localized, intermediate, or severe epidermolysis bullosa simplex (EBS). Each patient (40 to complete) will be enrolled in the study and will be randomized to receive either TolaSure Gel or a topical Placebo for daily application for 2-months. After 2-months, all patients will receive TolaSure Gel to daily apply for an additional 2-months. A remote follow-up visit will occur 2-months after the end of study. Total time in the study is 6-months. Localized patients will be applying study medication to their feet, with the option to treat their hands as well throughout the study. Intermediate and severe EBS patients will be applying study medication to randomized treatment area(s) (a minimum of \~2-3% Body Surface Area (BSA)), with the option to treat their feet as well throughout the study.
This is a closed-label, Phase II clinical study to assess the efficacy, safety and tolerability of the investigational product (IP), topical TolaSure Gel, 5% w/w, in adults and pediatric patients diagnosed with localized, intermediate, or severe epidermolysis bullosa simplex (EBS). TolaSure Gel, 5% w/w and Placebo tubes will be placed into kits where all labels (tubes and kit labels) will be blinded for drug content. Kits will be bundled (based on expected amount of study gel usage) and distributed randomly to patients [Goal of patient population, 1:1 M:F and approximately 70% pediatric patients].
Each patient (40 to complete) will be enrolled in the study and once a blistering flare is confirmed by the clinical study team, and the patient will be randomized to receive either TolaSure Gel, 5% w/w or Placebo (50:50 chance).
For Part I of the study, participants apply the randomized study treatment once daily for 2 months to a defined Target Lesional Area (TLA). The TLA and clinical presentation required for enrollment for each EBS subtype is described below.
For localized EBS subjects, the TLA will consist of daily treating the feet (tops and bottoms) which is approximately 7% body surface area (BSA). At the Baseline Visit, localized EBS subjects must have at least moderate plantar disease activity, defined as ≥15% involvement of the plantar surface of at least one foot, as assessed by clinical examination or standardized imaging, with evidence of active disease (e.g., blisters, erosions, or crusting). Localized EBS subjects will also have the option to treat their hands (tops and bottoms), which is approximately an additional 6% BSA. Palmoplantar evaluations for localized EBS subjects are separate from the intermediate to severe EBS subjects' TLA-treated regions per protocol.
For intermediate to severe EBS subject, the TLA can be a contiguous or non-contiguous region totaling up to approximately 15-20% BSA, excluding palmoplantar surfaces, groin, and apocrine areas. At the subject Baseline Visit, intermediate to severe EBS subject's TLA must consist of a 2-3% BSA active flaring sub-region consisting mainly of intact or freshly ruptured blisters. Subjects have the option to treat their feet, but plantar evaluation for intermediate to severe EBS subjects is separate from the TLA per protocol.
Study drug (TolaSure Gel, 5% w/w or Placebo Gel) is applied to the entire TLA, not just the symptomatic regions (e.g., blistering, keratoderma, erosions, crusting). If symptoms resolve, treatment continues daily on all assigned TLAs.
For Part 2 of the study, a single arm crossover will then allow those subjects that received Placebo to go on TolaSure Gel, 5% w/w for a subsequent 2 months. The subjects already in the TolaSure Gel, 5% w/w cohort will continue with daily IP application for an additional 2 months as well.
At End of Study (EOS), subjects will cease IP application and EOS procedures will be completed. A subject follow-up visit will occur after 6 months.
The primary endpoint will assess changes in disease severity within the TLAs (excluding palmoplantar surfaces) and recurrence of blistering using clinical imaging of blister surface area over time. The secondary efficacy endpoints will evaluate blistering on the feet, subject self-assessments including pain, itch, modified Foot Function Index (mFFI), and Quality of Life (QoL) assessment. An exploratory endpoint will examine blistering and keratoderma of localized EBS subjects that treat their hands.
Safety endpoints will include the incidence of treatment-emergent adverse events (TEAEs). In order to provide adequate assurance of subject safety, safety monitoring will include physical exams, vital sign measurements, clinical laboratory testing (blood and urinalysis), and urine pregnancy testing (as appropriate). These safety assessments in addition to AE reviews will be sufficient to identify potential TEAEs.
The information obtained from these assessments will be utilized to examine the efficacy of TolaSure treatment in ameliorating EBS symptoms as well as the accuracy of the proposed mechanism of action (MOA) of TolaSure for this disease indication.
20 studies on the registry are indexed under Epidermolysis Bullosa Simplex; 5 are open to participants now.
This study's planned enrollment of 40 is above the median of 19 across 17 interventional studies indexed under Epidermolysis Bullosa Simplex.
Browse Epidermolysis Bullosa Simplex studies →BioMendics, LLC is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For localized EBS participants:
For intermediate to severe EBS participants: Patient is actively flaring in one of the preferred target lesional areas (TLAs): 1) lower extremities (ideally below the knee and above the ankle or between the knee and top of the thigh) or 2) torso (excluding the groin and apocrine areas). The following skin conditions are required for treatment purposes:
If the patient is a woman of (WOCBP),
Exclusion Criteria:
Patient's use of prior or concomitant medication or medical treatments/procedures:
Patient's medical history includes:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
5% (w/w) TolaSure Gel
Drug: 5% TolaSure Topical Gel
Placebo Control Gel
Drug: Topical Placebo Gel
TolaSure Topical Gel is applied once-daily to designated treatment areas for up to 4 months (Part 2 End of Study).
Topical Placebo Gel is applied once-daily to designated treatment areas for up to 2 months (Part 1 End of Study).
Change in Blister Surface Area of the Designated Treatment Area(s)
Clinical photography will be used to assess changes in disease severity within the target lesional area (TLA) and recurrence of blistering by measuring blister surface area in the designated TLA over time.
Time frame: Day 1 (Baseline) and weekly until End of Study (2-months and maximum 4-months)
Plantar Blister Surface Area Reduction
Plantar blister surface area changes over time will be examined using clinical photography for localized EBS patients that treat their feet and those intermediate to severe EBS subjects that opt-in to treat their feet.
Time frame: Day 1 (Baseline) and weekly until End of Study (2-months and maximum 4-months)
Subject-reported Pain Score in Target Lesional Areas During Treatment Application
Using the adult or pediatric PROMIS® Measure form, peak pain during treatment application will be reported on a weekly basis until Part 2 End of Study (EOS, 4-months), with a possible assessment at the 6-month follow up visit. Pain trends in TolaSure Gel, 5% w/w and Placebo groups will be compared. The following PROMIS® Measure forms will be used depending on the patient's age: The Adult Pain Interference-Short Form 8a, Pediatric Pain Interference-Short Form 8a, and Parent Proxy Pain Interference-Short Form 8a. These scales are from 1 to 5 and relate to how much pain interferes with daily activities, with 1 indicating Never/Not at All and 5 indicating Almost Always/Very Much. For 2-4 year-old subjects, worst pain Numeric Rating Scale (NRS) questionnaire will be reported by caregivers/guardians. Pain NRS is from 0 to 10 with 0=no pain and 10=worst pain imaginable.
Time frame: Day 1 (Baseline) and weekly until End of Study (2-months and maximum 4-months)
Subject-reported Itch Score in Target Lesional Area
Using the adult or pediatric PROMIS® Measure form, itch characteristics will be reported on a weekly basis until Part 2 End of Study (EOS, 4-months), with a possible assessment at the 6-month follow up visit. Itch trends in TolaSure Gel, 5% w/w and Placebo groups will be compared. The following PROMIS® Measure forms will be used depending on the patient's age: The Adult Itch Interference-Short Form 8a, Pediatric Itch-Short Form 8a (PIQ-C), and Parent Proxy Itch-Short Form 8a (PIQ-C). These scales are from 1 to 5 and relate to how much itch interferes with daily activities and the level of itch, with 1 indicating Never/No Itch and 5 indicating Almost Always/Very Severe. For 2-4 year-old subjects, worst scratch/itch Numeric Rating Scale (WSI-NRS) questionnaire will be reported by caregivers/guardians. WSI-NRS is from 0 to 10 with 0=no itching or scratching and 10=worst imaginable itching or scratching.
Time frame: Day 1 (Baseline) and weekly until End of Study (2-months and maximum 4-months)
Subject-reported Quality of Life (QoL)
Patient's quality of life (QoL) metrics, highlighting symptoms and daily living concerns of EBS patients, will be reported at Visit 2/ Baseline, Part 1 End of Study (EOS), and Part 2 EOS, with a possible assessment at the 6-month follow up visit. This QoL assessment will be given to patients in a questionnaire format. The questions focus on how EBS blistering areas affect daily physical and social activities as well as mental and emotional health. The scale range is from 0 to 10, with 0 being not at all affected and 10 being severely affected. QoL metrics in TolaSure Gel, 5% w/w and Placebo control groups will be examined.
Time frame: Day 1 (Baseline), Part 1 End of Study (2-months), Part 2 End of Study (4-months)
Subject-reported Modified Foot Function Index (mFFI)
Patient's modified Foot Function Index (mFFI), is a questionnaire about foot pathology as it relates to pain, disability, and/or activity restrictions. Questions relating to pain are on a 0 to 10 scale with 0 being no pain at all and 10 being the worst pain imaginable. Daily activity scores also range from 0 to 10 with 0 being Not at All/Not Difficult at All and 10 being All the Time/So Difficult. The mFFI questionnaire will be reported at Visit 2/ Baseline, Part 1 End of Study (EOS), and Part 2 EOS, with a possible assessment at the 6-month follow up visit. mFFI metrics in TolaSure Gel, 5% w/w and Placebo control groups will be examined.
Time frame: Day 1 (Baseline), Part 1 End of Study (2-months), Part 2 End of Study (4-months)
Incidence of treatment-emergent adverse events (TEAEs)
Safety monitoring will include clinical laboratory testing (blood and urine) and urine pregnancy testing (as appropriate) only at Visit 1/Screening and Part 2 EOS, physical examinations (including assessment of treatment areas), and vital sign measurements at baseline and bi-weekly until Part 1 EOS and Part 2 EOS. These assessments along with AE reviews will identify potential TEAEs.
Time frame: Day 1 (Baseline) and bi-weekly until End of Study (maximum 4-months)
Blistering and Keratoderma of Hands
Changes to blister surface area and keratoderma over time on the hands of localized EBS subjects will be examined using clinical photography.
Time frame: Day 1 (Baseline) and weekly until End of Study (2-months and maximum 4-months)
Plan to share: No
Started Sep 2025 (actual). Primary completion is estimated for Jan 2027, 16 months after the start.
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Epidermolysis Bullosa Simplex →
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