Epidermolysis Bullosa DystrophicaEarly Phase 1SASSNCT04171661
Self-Assembled Skin Substitute for the Treatment of Epidermolysis Bullosa
A Early Phase 1 study testing SASS in people with Epidermolysis Bullosa Dystrophica, run by CHU de Quebec-Universite Laval at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epidermolysis Bullosa Dystrophica
- What is being tested?
- SASS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- 10 Dec 2019to 18 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
This clinical trial was custom designed for one patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SASS 3: Self-Assembled Skin Substitute (SASS) for the Treatment of Epidermolysis Bullosa
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.
- Conditions
- Epidermolysis Bullosa Dystrophica
- Being tested
- SASS
- Keywords
- Dystrophic Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa, Tissue Engineering, Skin Substitute
- Medical subject headings
- Epidermolysis Bullosa Dystrophica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SASSBiological
SASS applied on chronic skin wounds as skin graft
| Study group | Role | What they receive |
|---|---|---|
| SASS | Experimental | SASS applied on chronic skin wounds as skin graft Receives: Biological: SASS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent reduction in wound surface area
Clinical assessment
Measured: 2 weeks
Secondary outcomes (6)
Graft failure
Clinical assessment
Measured: 2 weeks
Number of subsequent re-transplantation
Number
Measured: 3 years
Time (in weeks) to 50% reduction in the surface area of the wounds;
Clinical assessment
Measured: 3 years
Time (in weeks) to complete healing
Clinical assessment
Measured: 3 years
Changes in pain scores
10 point visual analog scale where 0 is none and 10 the worst pain
Measured: 3 years
Changes in itch scores where 0 is none and 10 the worst itch
10 point scale
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start10 Dec 2019
- Primary completion24 Dec 2019
- Study completion18 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidermolysis Bullosa DystrophicaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- n-of-one
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171661
- Sponsor's protocol ID
- LOEX 019
- Acronym
- SASS
- Status last verified
- Mar 2026
- First submitted
- 19 Nov 2019
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SASS 3: Self-Assembled Skin Substitute (SASS) for the Treatment of Epidermolysis Bullosa
- ClinicalTrials.gov ID
- NCT04171661
- Acronym / sponsor ID
- SASS / LOEX 019
- Conditions
- Epidermolysis Bullosa Dystrophica
- Keywords
- Dystrophic Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa, Tissue Engineering, Skin Substitute
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 24 Dec 2019 (actual)
- Study completion
- 18 Dec 2026 (estimated)
- First posted
- 21 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- n-of-one
| Arm | Type | Receives |
|---|---|---|
| SASS | Experimental | Biological: SASSSASS applied on chronic skin wounds as skin graft |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SASSSASS applied on chronic skin wounds as skin graft | Biological | SASS |
Primary outcome
Percent reduction in wound surface area
Time frame: 2 weeks
Clinical assessment
6 secondary outcomes
Graft failure
Time frame: 2 weeks
Number of subsequent re-transplantation
Time frame: 3 years
Time (in weeks) to 50% reduction in the surface area of the wounds;
Time frame: 3 years
Time (in weeks) to complete healing
Time frame: 3 years
Changes in pain scores
Time frame: 3 years
Changes in itch scores where 0 is none and 10 the worst itch
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing SASS in people with Epidermolysis Bullosa Dystrophica, run by CHU de Quebec-Universite Laval at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent reduction in wound surface area (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.