An Investigation into the Long-term Safety of Zorblisa (SD-101-6.0) cream used by Patients with Epidermolysis Bullosa.

An Open Label, Multi-center, Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients with Epidermolysis Bullosa - Study to Evaluate the Long-term Safety of Zorblisa in Patients with Epidermolysis Bullosa

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005679-96-AT

Enrollment

150

Registered

2015-02-12

Start date

2015-03-16

Completion date

Unknown

Last updated

2018-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidermolysis Bullosa MedDRA version: 20.0 Level: PT Classification code 10014989 Term: Epidermolysis bullosa System Organ Class: 10010331 - Congenital, familial and genetic disorders

Interventions

Product Name: Zorblisa Product Code: SD-101 Pharmaceutical Form: Cream INN or Proposed INN: ALLANTOIN CAS Number: 97-59-6 Other descriptive name: ALLANTOIN Concentration unit: % (W/V) percent weight/v

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Informed Consent form signed by the patient or patient's legal representative; if the patient is under the age of 18 but capable of providing assent, signed assent from the patient. 2. Patient (or caretaker) must be willing to comply with all protocol requirements. 3. Patient who completed the SD-005 study (on study drug at Visit 5) Are the trial subjects under 18? yes Number of subjects for this age range: 100 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Patients who do not meet the entry criteria outlined in the Inclusion criteria. 2. Pregnancy or breastfeeding during the study. (A urine pregnancy test will be performed at the final visit for SD-005 for female patients of childbearing potential and repeated at Visit 1 if these visits do not occur on the same day) 3. Females of childbearing potential who are not abstinent or not practicing a medically acceptable method of contraception.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to demonstrate the long-term safety of ZORBLISA in patients, with Simplex, Recessive Dystrophic and Junctional non-Herlitz Epidermolysis Bullosa.;Secondary Objective: The secondary objectives are to assess the efficacy of ZORBLISA in terms of the change in Body Surface Area (BSA) of lesional skin and wound burden; as well as closure of unhealed target wounds from the SD-005 study ;Primary end point(s): The primary endpoint is the long-term safety of ZORBLISA in patients with Simplex, Recessive Dystrophic, and Junctional non-Herlitz Epidermolysis Bullosa;Timepoint(s) of evaluation of this end point: Safety is assessed via monitoring of local tolerability at the application sites, occurrence of adverse events and physical examinations at Months 1,3,6,9,12,15,18, and 21	—

Measure

Time frame

Main Objective: The primary objective is to demonstrate the long-term safety of ZORBLISA in patients, with Simplex, Recessive Dystrophic and Junctional non-Herlitz Epidermolysis Bullosa.;Secondary Objective: The secondary objectives are to assess the efficacy of ZORBLISA in terms of the change in Body Surface Area (BSA) of lesional skin and wound burden; as well as closure of unhealed target wounds from the SD-005 study ;Primary end point(s): The primary endpoint is the long-term safety of ZORBLISA in patients with Simplex, Recessive Dystrophic, and Junctional non-Herlitz Epidermolysis Bullosa;Timepoint(s) of evaluation of this end point: Safety is assessed via monitoring of local tolerability at the application sites, occurrence of adverse events and physical examinations at Months 1,3,6,9,12,15,18, and 21

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Secondary

Measure	Time frame
Secondary end point(s): The secondary endpoints include the change from baseline in BSA coverage of lesional skin and wound burden; as well as closure of unhealed target wounds from the SD-005 study. ;Timepoint(s) of evaluation of this end point: - Change in lesional skin based on BSA estimates at Months 1,3,6,9,12,15,18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48 compared to Baseline - Change in total body wound coverage based on BSA estimates at Months 1,3,6,9,12,15,18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48 compared to Baseline - For target wounds that are not closed by the end of Study SD-005, the target wound area at the final visit for Study SD-005 will be used as the baseline area size of the target wound for SD-006. Target wounds will be assessed at each subsequent visit until the wound is documented as closed.	—

Measure

Time frame

Secondary end point(s): The secondary endpoints include the change from baseline in BSA coverage of lesional skin and wound burden; as well as closure of unhealed target wounds from the SD-005 study. ;Timepoint(s) of evaluation of this end point: - Change in lesional skin based on BSA estimates at Months 1,3,6,9,12,15,18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48 compared to Baseline - Change in total body wound coverage based on BSA estimates at Months 1,3,6,9,12,15,18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48 compared to Baseline - For target wounds that are not closed by the end of Study SD-005, the target wound area at the final visit for Study SD-005 will be used as the baseline area size of the target wound for SD-006. Target wounds will be assessed at each subsequent visit until the wound is documented as closed.

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Countries

Australia, Austria, Belgium, Bulgaria, France, Germany, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Serbia, Spain, United Kingdom, United States

Contacts

Public ContactJamie L. Gault

Scioderm, INC.

jamie.gault@sderm.com001919328-2022

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026