Clinical Trials

Phase I Clinical Trial of TolaSure for Simplex

Date Updated:
EB Type: Epidermolysis Bullosa Simplex
Name of Company: BioMendics
Recruitment Status: Completed

About the Study

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.

All costs, including travel, lodging, transportation, and food will be covered, and the participants will also receive a stipend for each in-person visit.

Trial Entry Criteria

  • Patient is a male or female at least 18 years of age.
  • Patient has a documented genetic mutation in either the keratin 14 (K14) or keratin 5 (K5) gene and that their EBS diagnosis and/or specific mutation are consistent with severe EBS (previously EBS-DM). (If severe EBS is suspected but not genetically confirmed, confirmatory testing will be performed).
  • Please click the link below for more inclusion and exclusion criteria.

Contacts & Location

If you have any questions or are interested in participating in this clinical trial, please contact:

Location:

Stanford University School of Medicine, Dermatology Department
Redwood City, California, United States, 94063

Get more information on ClinicalTrials.gov

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