An Open Label Extension Safety Study to Evaluate SD-101 in Epidermolysis Bullosa
ConditionEpidermolysis Bullosa (EB)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age28-12
SponsorParadigm Therapeutics
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Subject (or caretaker) must be willing to comply with all protocol requirements.
Subjects must complete the SD-007 study.
Disqualifiers
Subjects who do not meet the entry criteria outlined above.
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)
Not of childbearing potential (premenarchal or male/not in possession of a uterus).
Abstinence from heterosexual intercourse as a lifestyle choice.
Trial design
Design model
Single group
Treatments tested in this trial
SD-101 Dermal Cream (6%)
DrugSD-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.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: SD-101 Dermal Cream (6%)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Measuring safety of SD-101-6.0
Evaluate the presence of Adverse Events of patients with Epidermolysis Bullosa using SD-101-6.0 Cream
Time frame
1 YearLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: