Actively Recruiting

Phase 2
Age: 4Years +
All Genders
NCT07027345

A Phase II, Placebo Controlled, Clinical Trial of Topical TolaSure Targeting Aggregated Mutant Keratin in Epidermolysis Bullosa Simplex

Led by BioMendics, LLC · Updated on 2025-09-11

40

Participants Needed

2

Research Sites

52 weeks

Total Duration

On this page

Sponsors

B

BioMendics, LLC

Lead Sponsor

N

Northwestern University Feinberg School of Medicine

Collaborating Sponsor

AI-Summary

What this Trial Is About

This Phase II clinical study will assess the efficacy, safety and tolerability of topical TolaSure Gel in adults and pediatric patients (4 years of age and older) diagnosed with generalized intermediate to 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. 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.

CONDITIONS

Official Title

A Phase II, Placebo Controlled, Clinical Trial of Topical TolaSure Targeting Aggregated Mutant Keratin in Epidermolysis Bullosa Simplex

Who Can Participate

Age: 4Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is male or female aged 4 years or older.
  • Diagnosed with generalized intermediate to severe epidermolysis bullosa simplex (EBS) or genetic mutation in K14 or K5 genes consistent with this severity.
  • Actively experiencing a blistering flare in lower extremities (between knee and ankle or thigh) or torso (excluding groin/apocrine areas).
  • Flare area covers about 2-3% of body surface area with intact or recently ruptured blisters.
  • Target lesional area is not infected and has not been treated with topical antibiotics within 14 days.
  • Women of childbearing potential must have a negative pregnancy test, agree to use effective birth control during and 3 months after the study, and not be nursing.
  • Laboratory blood and urine values are within normal or acceptable ranges.
  • In good general health without conditions that impair study evaluation or increase risk.
  • Agree to avoid other topical therapies or dressings on target areas during the study.
  • Able and willing to follow study procedures and sign informed consent or assent.
Not Eligible

You will not qualify if you...

  • Use of any investigational drug or therapy within 30 days.
  • Use of systemic steroids within 30 days.
  • Use of topical steroids within 14 days (except inhaled or ophthalmic steroids).
  • Use of systemic antibiotics within 7 days.
  • Currently undergoing chemotherapy or radiation.
  • Surgery within the last 2 weeks except minor, cosmetic, or dental procedures.
  • Starting chronic medications less than 30 days before study medication.
  • Current cancer treatment.
  • History of severe vitamin, mineral, or protein deficiency.
  • Current systemic infection.
  • HIV/AIDS.
  • Non-EBS skin diseases or conditions that pose risk or interfere with treatment or assessments.
  • Illness or conditions likely to interfere with study participation.
  • Inability to attend visits or follow study protocol.
  • Investigator or immediate family member of investigational team.
  • Other reasons deemed unsuitable by the investigator.

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Stanford University School of Medicine, Dermatology Department

Palo Alto, California, United States, 94304

Actively Recruiting

2

NU Dermatolgy CTU

Chicago, Illinois, United States, 60611

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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