Back to resultsSelf-Assembled Skin Substitute for the Treatment of Epidermolysis Bullosa (SASS)
Primary Purpose
Epidermolysis Bullosa Dystrophica
Status
Active
Phase
Early Phase 1
Locations
Canada
Study Type
Interventional
Intervention
SASS
Sponsored by
About this trial
This is an interventional treatment trial for Epidermolysis Bullosa Dystrophica focused on measuring Dystrophic Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa, Tissue Engineering, Skin Substitute
Eligibility Criteria
This clinical trial was custom designed for one patient
Sites / Locations
- The Hospital for Sick Children
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SASS
Arm Description
SASS applied on chronic skin wounds as skin graft
Outcomes
Primary Outcome Measures
Percent reduction in wound surface area
Clinical assessment
Secondary Outcome Measures
Graft failure
Clinical assessment
Number of subsequent re-transplantation
Number
Time (in weeks) to 50% reduction in the surface area of the wounds;
Clinical assessment
Time (in weeks) to complete healing
Clinical assessment
Changes in pain scores
10 point visual analog scale where 0 is none and 10 the worst pain
Changes in itch scores where 0 is none and 10 the worst itch
10 point scale
Full Information
NCT ID
NCT04171661
First Posted
November 19, 2019
Last Updated
February 16, 2023
Sponsor
CHU de Quebec-Universite Laval
Collaborators
The Hospital for Sick Children
1. Study Identification
Unique Protocol Identification Number
NCT04171661
Brief Title
Self-Assembled Skin Substitute for the Treatment of Epidermolysis Bullosa
Acronym
SASS
Official Title
SASS 3: Self-Assembled Skin Substitute (SASS) for the Treatment of Epidermolysis Bullosa
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
December 24, 2019 (Actual)
Study Completion Date
December 10, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Quebec-Universite Laval
Collaborators
The Hospital for Sick Children
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Single patient study. Patient diagnosed with dystrophic epidermolysis bullosa presenting chronic open wounds that are not responding to dressings, topical preparations (antimicrobials, antibiotics) and systemic agents (anti-inflammatory antibacterials). The Self-Assembled Skin Substitutes will be used to cover wounds.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epidermolysis Bullosa Dystrophica
Keywords
Dystrophic Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa, Tissue Engineering, Skin Substitute
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
n-of-one
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SASS
Arm Type
Experimental
Arm Description
SASS applied on chronic skin wounds as skin graft
Intervention Type
Biological
Intervention Name(s)
SASS
Intervention Description
SASS applied on chronic skin wounds as skin graft
Primary Outcome Measure Information:
Title
Percent reduction in wound surface area
Description
Clinical assessment
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Graft failure
Description
Clinical assessment
Time Frame
2 weeks
Title
Number of subsequent re-transplantation
Description
Number
Time Frame
3 years
Title
Time (in weeks) to 50% reduction in the surface area of the wounds;
Description
Clinical assessment
Time Frame
3 years
Title
Time (in weeks) to complete healing
Description
Clinical assessment
Time Frame
3 years
Title
Changes in pain scores
Description
10 point visual analog scale where 0 is none and 10 the worst pain
Time Frame
3 years
Title
Changes in itch scores where 0 is none and 10 the worst itch
Description
10 point scale
Time Frame
3 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
This clinical trial was custom designed for one patient
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Self-Assembled Skin Substitute for the Treatment of Epidermolysis Bullosa
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