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Active, not recruitingNCT04171661SASSUpdated Mar 19, 2026

Self-Assembled Skin Substitute for the Treatment of Epidermolysis Bullosa

An Early Phase 1 interventional study of SASS in Epidermolysis Bullosa Dystrophica, sponsored by CHU de Quebec-Universite Laval. Active, not recruiting at 1 site in Canada. Per ClinicalTrials.gov, last updated 2026-03-19.

Sponsored by CHU de Quebec-Universite Laval · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Sex
All
01

Study 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.

02

Conditions studied

  • Epidermolysis Bullosa Dystrophica

Keywords

  • Dystrophic Epidermolysis Bullosa
  • Recessive Dystrophic Epidermolysis Bullosa
  • Tissue Engineering
  • Skin Substitute
03

In context

Epidermolysis Bullosa Dystrophica

77 studies on the registry are indexed under Epidermolysis Bullosa Dystrophica; 20 are open to participants now.

This study's enrollment of 1 is below the median of 9 across 54 interventional studies indexed under Epidermolysis Bullosa Dystrophica.

Browse Epidermolysis Bullosa Dystrophica studies →

Lead sponsor

CHU de Quebec-Universite Laval is the lead sponsor of 134 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

This clinical trial was custom designed for one patient

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    SASS

    SASS applied on chronic skin wounds as skin graft

    Biological: SASS

Interventions

  • BiologicalSASS

    SASS applied on chronic skin wounds as skin graft

06

What researchers measure

Primary outcomes

  1. Percent reduction in wound surface area

    Clinical assessment

    Time frame: 2 weeks

Secondary outcomes

  1. Graft failure

    Clinical assessment

    Time frame: 2 weeks

  2. Number of subsequent re-transplantation

    Number

    Time frame: 3 years

  3. Time (in weeks) to 50% reduction in the surface area of the wounds;

    Clinical assessment

    Time frame: 3 years

  4. Time (in weeks) to complete healing

    Clinical assessment

    Time frame: 3 years

  5. Changes in pain scores

    10 point visual analog scale where 0 is none and 10 the worst pain

    Time frame: 3 years

  6. Changes in itch scores where 0 is none and 10 the worst itch

    10 point scale

    Time frame: 3 years

07

Study locations

1 site
  • The Hospital for Sick Children
    Toronto, Ontario M5G 1X8, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04171661
Lead sponsor
CHU de Quebec-Universite Laval
Collaborators
The Hospital for Sick Children
Responsible party
Sponsor
First posted
Nov 21, 2019
Start date
Dec 10, 2019
Primary completion
Dec 24, 2019
Completion
Dec 18, 2026 (estimated)
Last update
Mar 19, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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