Epidermolysis Bullosa (EB)
Conditions
Brief summary
The objective is to characterize the continued safety of SD-101 cream containing 6% allantoin in the treatment of the skin in patients with Simplex, Recessive Dystrophic, or JEB-nH EB.
Detailed description
This is an open label extension, multi-center, study to assess the continued safety of topically applied SD-101 cream containing (6% allantoin) across the entire skin surface in subjects with Simplex, Recessive Dystrophic, or Junctional non-Herlitz (JEB-nH) EB. SD-101 cream (containing 6% allantoin) will be applied topically, once a day to the entire body for a period of up to 1 year or until approval. Subjects who complete the SD-007 study will roll over into the SD-008 open label extension study. The baseline visit 1 for SD-008 will occur at the time of the final visit for SD-007. The safety evaluation from the SD-007 final visit will provide the baseline safety assessment for the SD-008 study.
Interventions
SD-101 is a white, crystalline powder that is formulated within an odorless, soft, white cream base. SD-101-6.0 cream contains allantoin, a diureide glyoxylic acid, at a concentration of 6% and other excipients.
Sponsors
Paradigm Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
28 Days to 12 Years
Healthy volunteers
No
Inclusion criteria
1. ICF signed by the subject or subject's legal representative; if the subject is under the age of 18 but capable of providing assent, signed assent from the subject. 2. Subject (or caretaker) must be willing to comply with all protocol requirements. 3. Subjects must complete the SD-007 study.
Exclusion criteria
1. Subjects who do not meet the entry criteria outlined above. 2. Pregnancy or breastfeeding during the study. (A urine pregnancy test will be performed at the final visit for SD-007 for female subjects of childbearing potential as assessed if needed by the investigator) 3. Participant is one of the following: 1. Not of childbearing potential (premenarchal or male/not in possession of a uterus). 2. If of childbearing potential, is nonpregnant (negative urine pregnancy test results at Screening), nonlactating, and practicing 1 of the following medically acceptable methods of birth control: * Abstinence from heterosexual intercourse as a lifestyle choice. * Hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the participant's usual menstrual cycle period) before product administration. * Intrauterine device. If male, is willing to use a highly effective method of contraception throughout the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measuring safety of SD-101-6.0 | 1 Year | Evaluate the presence of Adverse Events of patients with Epidermolysis Bullosa using SD-101-6.0 Cream |
Contacts
CONTACTKathleen Watts
CONTACTRobert P Ryan, PhD
Outcome results
None listed