Topical BPM31510 3.0% Cream in Patients With Epidermolysis Bullosa

Inclusion Criteria

• •1. Male or female at least 12 years of age at the time of screening.
• •2. Have primary, histologically confirmed EB verified by immunofluorescent antigenic mapping (EM) prior to starting application of study drug
• •3. Have no other dermatological disease that may adversely impact wound healing.
• •4. Willing to refrain from using topical creams or lotions other than the study drug to the designated areas during the treatment period and from washing the designated areas until the next application is done.
• •5. Willing to refrain from exposure to excessive direct sunlight or ultraviolet light for the duration of the study.
• •6. Laboratory values for the tests listed in the Study Schedule are within the local reference ranges as defined by the local laboratory, or "out of range" test results are clinically acceptable to the investigator. Acceptable "out of range" values are generally those within the patient's normal baseline levels due to concurrent medications or disease processes with the exception of INR and PT/APTT.
• •7. Caregiver/guardian or patient is able to follow study required instructions and likely to complete all study visit requirements.
• •8. Has a provided written informed consent by patient or a legal guardian, including consent for tissue to be examined and stored by the Department of Dermatology and Cutaneous Surgery. If the patient is between 12 and 17 years of age, assent must be given by the patient.
• •9. Guardian has provided written consent to allow photographs of the target EB lesion(s) to be used as part of the study data and documentation.
• •10. Females of childbearing potential must have a negative urine or serum pregnancy test at screening and be using an acceptable form of birth control (oral/implant/injectable/transdermal contraceptives, intrauterine device, condom, diaphragm, abstinence, or a monogamous relationship with a partner who has had a vasectomy).
• •11. Have an INR value of 0.8-1.2 as well as normal PT/APTT.
• •12. With at least 1 active EB wound between 2.5 and 50 cm2 in size on nonflexual surfaces