Self-Assembled Skin Substitute for the Treatment of Epidermolysis Bullosa

Epidermolysis Bullosa Dystrophica Clinical Trial

— SASS  

Official title:

SASS 3: Self-Assembled Skin Substitute (SASS) for the Treatment of Epidermolysis Bullosa

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04171661
• Other study ID #: LOEX 019
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: December 10, 2019
• Est. completion date: December 10, 2024

Study information

• Verified date: February 2023
• Source: CHU de Quebec-Universite Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1
• Est. completion date: December 10, 2024
• Est. primary completion date: December 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older
• Eligibility: This clinical trial was custom designed for one patient

Related Conditions & MeSH terms

• Epidermolysis Bullosa
• Epidermolysis Bullosa Dystrophica

Intervention

Biological:
• SASS
SASS applied on chronic skin wounds as skin graft

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval	The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent reduction in wound surface area	Clinical assessment	2 weeks
Secondary	Graft failure	Clinical assessment	2 weeks
Secondary	Number of subsequent re-transplantation	Number	3 years
Secondary	Time (in weeks) to 50% reduction in the surface area of the wounds;	Clinical assessment	3 years
Secondary	Time (in weeks) to complete healing	Clinical assessment	3 years
Secondary	Changes in pain scores	10 point visual analog scale where 0 is none and 10 the worst pain	3 years
Secondary	Changes in itch scores where 0 is none and 10 the worst itch	10 point scale	3 years