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Safety and Efficacy of Topical TolaSure Targeting Aggregated Mutant Keratin in Severe Epidermolysis Bullosa Simplex

NCT05062070 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-09-11

No results posted yet for this study

Summary

TolaSure is a topical gel for the promotion of accelerated wound healing. This Phase I study will assess the safety, tolerability, and clinical effects of TolaSure when applied to wounded skin areas of patients diagnosed with severe epidermolysis bullosa simplex (i.e., EBS-Dowling Meara). A total of 10, severe EBS patients, males and females ages 18 years and older, will be enrolled. Patients will apply TolaSure and Vehicle Gel once-daily for a maximum of 10 weeks.

Conditions

  • Epidermolysis Bullosa Simplex

Interventions

DRUG

TolaSure Topical Gel

TolaSure Topical Gel is applied once-daily for up to 10 weeks to designated Treatment Area and Suction Blister Area.

DRUG

Vehicle Topical Gel

TolaSure Vehicle Gel is applied once-daily for up to 10 weeks to designated Treatment Area and Suction Blister Area.

Sponsors & Collaborators

  • BioMendics, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-05
Primary Completion
2023-06-22
Completion
2023-06-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05062070 on ClinicalTrials.gov