University of Miami and Berg Health’s Phase I Study of Topical BPM31510 3.0% Cream in Patients with Epidermolysis Bullosa

Below you will find updated information about the University of Miami and Berg Health’s active EB trial. The purpose of this study is to evaluate the safety, pharmacokinetics and therapeutic effect of topical BPM31510 3.0% cream in patients with all forms of Epidermolysis Bullosa.


University of Miami and Berg Health Flyer

Click here to enlarge


About the Study

The primary objective of the study is to evaluate the safety and tolerability in patients with EB when treated with topical BPM31510 3% cream. The secondary objectives are to (1) evaluate the pharmacokinetics of BPM31510 3% cream, and (2) evaluate the reduction in pain, improvement in quality of life, time to healing, quality of healing, increased resistance to trauma, and reduction in blister formation. The exploratory objective is evaluation of skin integrity and wound healing through Reflectance Confocal Microscopy (RCM).  RCM is a cutting-edge imaging device that provides in vivo evaluation of skin without taking biopsies.

Patients remain on study for up to 18 weeks: up to 2 weeks of screening, 12 weeks of treatment and a 4 week follow up period. The study drug, BPM31510 is an ubidecarenone (Coenzyme Q10; CoQ10) containing cream formulation that has significant effect on several molecular, cellular and biochemical parameters associated with wound healing as determined using established in vitro and in vivo models. BPM31510 mediated delivery of CoQ10 to the mitochondria is associated with significant, dose dependent increase in ATP generation and increase metabolic activity in fibroblasts and keratinocytes.

Trial Entry Criteria

  • Participants must be ages 12 years and older (Child, Adult, Senior)
  • Participants must have histologically confirmed EB verified by immunofluorescent antigenic mapping (EM) or equivalent confirmation testing prior to starting application of study drug
  • Participants must be willing to refrain from using topical creams or lotions other than the study drug to the designated areas during the treatment.
  • Please visit https://clinicaltrials.gov/ct2/show/NCT02793960 for all inclusion and exclusion criteria.

A travel stipend may be provided. For further information about the study, or to participate, click here.

For more information, contact Aliette Espinosa, Clinical Research Coordinator, at 305-689-3376 or a [dot] espinosa2 [at] med [dot] miami [dot] edu.