NL-OMON47706
Completed
Phase 2
An International, Multicenter, Randomized, Double-Blind, Parallel-Group Phase 2 Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS) [DELIVERS Study] - DELIVERS
Castle Creek Pharmaceuticals, LLC0 sites4 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Castle Creek Pharmaceuticals, LLC
- Enrollment
- 4
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subject is male or female at least 4 years of age at Visit 1
- •2\. Subject has a documented genetic mutation consistent with EBS. A blood or saliva sample will be collected for genetic confirmation if no documented gene mutation data is available. Gene mutations acceptable for inclusion are as follows: KRT5, KRT14, PLEC1, TGM5, PKP1, DSP, FERMT1, EXPH5, DST, KLHL24\.
- •3\. Subject has an Assessment Area of EBS lesions to be treated, that is \*2% body surface area (BSA) and the EBS lesions are in one or both of the following body areas:
- •\- Localized: plantar and/or palmar areas (plantar areas where \>25% of the area has hyperkeratosis that has been present for greater than 12 weeks cannot be included as part of the Assessment Area)
- •\- Generalized: arms, legs, torso, hands and feet (scalp, groin and areas where, in the investigator\*s opinion, the study medication might become occluded cannot be included as part of the Assessment Area
- •4\. Subject\*s EBS lesions in the Assessment Area have an Investigator\*s Global Assessment (IGA) score of \*3
- •5\. Subject/caregiver agrees to not use any topical therapies other than the study medication that, might influence the status of the EBS lesions during the duration of the study (e.g., medicated cleansers, CBD oil, MediHoney, Silvadine cream 1%); the Investigator should consult the Medical Monitor regarding therapies not specified in the protocol
- •6\. Subject/caregiver agrees to follow topical product application instructions during the treatment period
- •7\. If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an approved effective method of birth control, as defined by this protocol (see Section 10\.6\), for the duration of the study.
- •8\. Subject is non\-pregnant, non\-lactating and is not planning for pregnancy during the study period
Exclusion Criteria
- •1\. Subject has EBS lesions to be treated that are infected (i.e., EBS lesions that require therapy to treat an infection)
- •2\. Subject has used any diacerein containing product within 6 months prior to Visit 1
- •3\. Subject has used systemic immunotherapy or cytotoxic chemotherapy within 60 days prior to Visit 1
- •4\. Subject has used systemic steroidal therapy or has used topical steroidal therapy on the EBS lesions to be treated within 30 days prior to Visit 2 (Note: inhaled and ophthalmic products containing steroids are allowed)
- •5\. Subject has evidence of a systemic infection or has used systemic antibiotics within 7 days prior to Visit 1
- •6\. Subject is currently using systemic analgesics and/or anti\-histamine therapy for treatment of EBS lesions, unless on a stable regimen (i.e., the same dosing regimen) for at least 4 weeks prior to Visit 1\. Note: As needed (PRN) use of acetaminophen/paracetamol or NSAIDs within the 4 weeks prior to Visit 1 are permitted provided the treatment was unrelated to EBS symptom relief.
- •7\. Subject has used any systemic diuretics or cardiac glycosides or any systemic product that, in the opinion of the investigator, might put the subject at undue risk by study participation or interferes with the study medication application or the study assessments within 30 days prior to Visit 1
- •8\. Subject has used any topical product containing allantoin on the EBS lesions to be treated within 30 days prior to Visit 1
- •9\. Subject has a current malignancy, or a history of treatment for a malignancy within 2 years prior to Visit 1 (Note: does not include non\-melanoma skin cancer)
- •10\. Subject currently has diabetes mellitus (HbA1c \*6\.5%). Note: controlled diabetes (HbA1c \< 6\.5%) is also considered exclusionary
Outcomes
Primary Outcomes
Not specified
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