Recessive Dystrophic Epidermolysis BullosaRDEBNCT05944250
A Pilot Study to Evaluate a Temporary Skin Substitute (Spincare® Matrix) for Wound Healing in RDEB Patients
A study testing Spincare matrix in people with Recessive Dystrophic Epidermolysis Bullosa, run by Stanford University at 1 site in United States.
Trial summary
Recessive dystrophic epidermolysis bullosa (RDEB) is a subtype of epidermolysis bullosa (EB), an inherited skin condition that presents with blistering skin. The Spincare device, developed by Nanomedic, is the first portable tool that delivers a non-invasive, non-therapeutic electrospun, nanofibrous matrix dressing to… Read more about this study
- Who is it for?
- Ages 6 to 65 years
- Conditions the study is for
- Recessive Dystrophic Epidermolysis Bullosa
- What is being tested?
- Spincare matrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2023to 14 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical and/or genetic diagnosis of RDEB by a dermatologist
- Age 6 years or older willing and able to give consent/assent
- At least 6 wounds (3 wound pairs) each with an area of 10cm2 or greater located at any site (excluding face and genital skin)
- Wounds must be present for at least 4 weeks and able to be classified as recurrent wounds (wounds that heal within 12 weeks but then re-blister) vs chronic open (older than 12 weeks)
Who cannot join
- Actively infected wounds with pus (colonized wounds are eligible)
- Wounds that have had squamous cell carcinoma (SCC)
- Wounds on the face and genitals
- Wounds that have been treated with investigational therapies in the past 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Discovery Hall Stanford University
Redwood City, California, 94063
About this study
Recessive dystrophic epidermolysis bullosa (RDEB) is a subtype of epidermolysis bullosa (EB), an inherited skin condition that presents with blistering skin. The Spincare device, developed by Nanomedic, is the first portable tool that delivers a non-invasive, non-therapeutic electrospun, nanofibrous matrix dressing to wounds to promote healing. The aim of this study is to determine the suitability of this device in RDEB wounds and assess its wound healing properties, safety and tolerability.
Read the detailed description
Investigators will aim to recruit a mixture of adult and pediatric patient. However, the first patient that is recruited would be an adult to collect safety and efficacy data before enrolling pediatric patients.
Screening- Patients would be screened over the phone to assess if they meet the inclusion and exclusion criteria. Thereafter a virtual meeting via a secure virtual platform is arranged for the patient to review the consent form and sign. Wounds will be assessed to see if they meet the inclusion and exclusion criteria.
Day 0 - A full body wound examination will be performed by the investigator and target wound areas will be marked. All eligible wound sites will be randomized for matrix treatment versus standard of care wound care (at least 6 wounds, or 3 wound pairs). The matrix will be applied to randomized treatment wounds, along with a non-adhesive bandage as a protective layer. Reapplication of matrix treatment may be required depending on how well the matrix has propagated. At the time of matrix application, the investigator will score amount of wound burning, pain, or other adverse events. Non-treated wounds will have the patient's standard of care, non-adhesive bandage applied. Subjects and caregivers will be trained on how take photos. The aim is to capture photos of the wounds, pain and itch scores at least every 2 weeks. Surveys will be completed by the caregiver to see if they notice any difference in the wounds with the spray treatment. This will be completed together with the patient's pain and itch surveys.
Day 1 and optional Day 2- Clinic Visits: A wound examination will be performed in clinic. The investigator will assess the adherence of the matrix, and any adverse events (AEs). Day 2 visit may be necessary at the discretion of the investigators especially if any adverse events have occurred.
Months 1, 2, 3, 4 Visits: clinic attendance for patients with EB may be stressful and inconvenient due to their complex wound pattern and dressing changes. Keeping their safety and dignity as a priority the remaining visits as home visits are conducted with telehealth assessment. This will be done over a secure virtual platform or phone call whereby the assessors will be consulting remotely from a private Stanford based office room. The caregiver will apply the matrix to randomized, treated wounds (up to once a week application is allowed, the date and reason for reapplication is required)(additional interim visits/telehealth assessment and reapplication of matrix treatment may occur at Week 1, Week 2, Week 6, Week 10 and Week 14 or more frequently if deemed necessary). Patients will be asked to record the date each time the Spincare was applied. Photographs will be taken at those timepoints, and investigators will use Telehealth to monitor for healing and safety reporting (additional weekly photographs are encouraged). At the time of matrix application, the amount of wound burning, pain, or other adverse events will be scored Month 4 Telehealth/End of study Visit: The investigator will virtually assess wound healing compared to baseline photographs in the treated and control wounds. Digital photographs of the treatment and control wounds will be taken with a ruler by the caregiver and sent to the investigator. All wound photos will be reviewed via RedCAP. Wound swabs will be collected from treated and untreated wounds prior to spray treatment and at Month 2 and Month 4.
Participants may be offered the choice to complete surveys online and/or upload photos via Stanford RedCap.
Open-Label (Extension) Phase: After the completion of the 4-month randomized phase, patients will choose to enroll in an open Open-Label Phase for an additional 4 months. Investigators will conduct remote monitoring on a monthly basis to assess adverse events and wound healing. Participants will complete surveys regarding their pain and itch, offer updates on their medical history, and provide information about concurrent medications. No blood draws, wound cultures and in person visits will be required during the Open-Label Phase.
- Being tested
- Spincare matrix
- 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.
Spincare matrixDevice
The Spincare device, developed by Nanomedic, is the first portable tool that delivers a non-invasive, non-therapeutic electrospun, nanofibrous matrix dressing to wounds to promote healing.
| Study group | Role | What they receive |
|---|---|---|
| Randomized Arm | Experimental | A full body wound examination will be performed by the investigator and target wound areas will be marked. All eligible wound sites will be randomized for matrix treatment versus standard of care wound dressings (at least 6 wounds, or 3 wound pairs). The matrix will be applied to randomized treatment wounds, along with a non-adhesive bandage as a protective layer. Receives: Device: Spincare matrix |
| Open-label Arm (extension) | Other | Participants who are eligible and choose to participate, will be enrolled at the 4 month long optional Open-Label Phase. Participant will be allowed to treat previously randomized wounds (treated and control wounds) and new wounds, up to a max of 10 individuals wounds; there won't be control or randomized wounds. Participants might reapply up to once a week, and wound healing and safety will be assessed at the monthly visits. Receives: Device: Spincare matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Wounds With Greater Than 90% Wound Closure at 4 Months
The primary endpoint was comparison of the duration of wound closure of matrix-treated wounds vs control wounds measured as the number of wounds achieving greater than 90% wound closure within 4 months
Measured: Baseline to month 4 of the randomized phase
Secondary outcomes (5)
Adverse Event Profile Characterization
Comparison of application site adverse events (burning, erythema, pain) between matrix-treated wounds vs control wounds after application. For this outcome, adverse events were collected per wound; events affecting the participant but not the wound are not included.
Measured: 4-month randomized period followed by 4-month open-label period
Change From Baseline in Wound Pain Scale Score Assessment
Pain was assessed using the Wong-Baker Faces scale (prior to matrix application). The scale consists of six faces that range from 0 (no pain at all, favorable outcome) to 10 (worst pain imaginable, worst outcome). Participants rated each wound using this scale, and scores were summed and averaged for each time point, resulting in an overall score range of 0 (no pain at all) to 10 (worst pain imaginable).
Measured: months 1, 2, 3, and 4 of the randomized phase
Change in Wound Itch Scale Score Assessment
Wound itch scores were assessed using the Itch NRS (prior to matrix application). The Itch NRS is a numerical rating scale from 0 to 10. Participants rated each wound using this scale, and scores were summed and averaged for each time point, resulting in an overall score of 0 to 10 (higher scores correspond to more pain).
Measured: months 1, 2, 3, and 4 of the randomized phase
Number of Wounds That Reach >50% Healing From Baseline Per Investigator Assessment
Comparison of wounds that reach >50% healing from baseline in matrix vs control (standard-of-care treated) wounds, per clinician assessment.
Measured: months 1, 2, 3, and 4 of the randomized phase
Number of Wounds That Reach >70% Healing From Baseline Per Investigator Assessment
Comparison of wounds that reach >70% healing from baseline in matrix-treated vs control wounds, per clinician assessment.
Measured: months 1, 2, 3, and 4 of the randomized phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start19 Sep 2023
- Primary completion14 Aug 2024
- Study completion14 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recessive Dystrophic Epidermolysis BullosaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Intra-patient randomization of wound pairs into control wounds vs matrix treated wounds, followed by an open-label (extension) phase without randomization
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Yuh Tang, Stanford University
- Investigators
- Jean Y Tang, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944250
- Sponsor's protocol ID
- 69575
- Acronym
- RDEB
- Status last verified
- Aug 2025
- First submitted
- 5 Jul 2023
- Last updated
- 15 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified coded data may be shared with collaborators, funding agency and presented at scientific meetings. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) would be shared.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate a Temporary Skin Substitute (Spincare® Matrix) for Wound Healing in RDEB Patients
- ClinicalTrials.gov ID
- NCT05944250
- Acronym / sponsor ID
- RDEB / 69575
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 14 Aug 2024 (actual)
- Study completion
- 14 Aug 2024 (actual)
- First posted
- 13 Jul 2023 (actual)
- Results
- Posted 15 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recessive dystrophic epidermolysis bullosa (RDEB) is a subtype of epidermolysis bullosa (EB), an inherited skin condition that presents with blistering skin. The Spincare device, developed by Nanomedic, is the first portable tool that delivers a non-invasive, non-therapeutic electrospun, nanofibrous matrix dressing to wounds to promote healing. The aim of this study is to determine the suitability of this device in RDEB wounds and assess its wound healing properties, safety and tolerability.
Detailed description
Investigators will aim to recruit a mixture of adult and pediatric patient. However, the first patient that is recruited would be an adult to collect safety and efficacy data before enrolling pediatric patients.
Screening- Patients would be screened over the phone to assess if they meet the inclusion and exclusion criteria. Thereafter a virtual meeting via a secure virtual platform is arranged for the patient to review the consent form and sign. Wounds will be assessed to see if they meet the inclusion and exclusion criteria.
Day 0 - A full body wound examination will be performed by the investigator and target wound areas will be marked. All eligible wound sites will be randomized for matrix treatment versus standard of care wound care (at least 6 wounds, or 3 wound pairs). The matrix will be applied to randomized treatment wounds, along with a non-adhesive bandage as a protective layer. Reapplication of matrix treatment may be required depending on how well the matrix has propagated. At the time of matrix application, the investigator will score amount of wound burning, pain, or other adverse events. Non-treated wounds will have the patient's standard of care, non-adhesive bandage applied. Subjects and caregivers will be trained on how take photos. The aim is to capture photos of the wounds, pain and itch scores at least every 2 weeks. Surveys will be completed by the caregiver to see if they notice any difference in the wounds with the spray treatment. This will be completed together with the patient's pain and itch surveys.
Day 1 and optional Day 2- Clinic Visits: A wound examination will be performed in clinic. The investigator will assess the adherence of the matrix, and any adverse events (AEs). Day 2 visit may be necessary at the discretion of the investigators especially if any adverse events have occurred.
Months 1, 2, 3, 4 Visits: clinic attendance for patients with EB may be stressful and inconvenient due to their complex wound pattern and dressing changes. Keeping their safety and dignity as a priority the remaining visits as home visits are conducted with telehealth assessment. This will be done over a secure virtual platform or phone call whereby the assessors will be consulting remotely from a private Stanford based office room. The caregiver will apply the matrix to randomized, treated wounds (up to once a week application is allowed, the date and reason for reapplication is required)(additional interim visits/telehealth assessment and reapplication of matrix treatment may occur at Week 1, Week 2, Week 6, Week 10 and Week 14 or more frequently if deemed necessary). Patients will be asked to record the date each time the Spincare was applied. Photographs will be taken at those timepoints, and investigators will use Telehealth to monitor for healing and safety reporting (additional weekly photographs are encouraged). At the time of matrix application, the amount of wound burning, pain, or other adverse events will be scored Month 4 Telehealth/End of study Visit: The investigator will virtually assess wound healing compared to baseline photographs in the treated and control wounds. Digital photographs of the treatment and control wounds will be taken with a ruler by the caregiver and sent to the investigator. All wound photos will be reviewed via RedCAP. Wound swabs will be collected from treated and untreated wounds prior to spray treatment and at Month 2 and Month 4.
Participants may be offered the choice to complete surveys online and/or upload photos via Stanford RedCap.
Open-Label (Extension) Phase: After the completion of the 4-month randomized phase, patients will choose to enroll in an open Open-Label Phase for an additional 4 months. Investigators will conduct remote monitoring on a monthly basis to assess adverse events and wound healing. Participants will complete surveys regarding their pain and itch, offer updates on their medical history, and provide information about concurrent medications. No blood draws, wound cultures and in person visits will be required during the Open-Label Phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intra-patient randomization of wound pairs into control wounds vs matrix treated wounds, followed by an open-label (extension) phase without randomization
| Arm | Type | Receives |
|---|---|---|
| Randomized Arm | Experimental | Device: Spincare matrixA full body wound examination will be performed by the investigator and target wound areas will be marked. All eligible wound sites will be randomized for matrix treatment versus standard of care wound dressings (at least 6 wounds, or 3 wound pairs). The matrix will be applied to randomized treatment wounds, along with a non-adhesive bandage as a protective layer. |
| Open-label Arm (extension) | Other | Device: Spincare matrixParticipants who are eligible and choose to participate, will be enrolled at the 4 month long optional Open-Label Phase. Participant will be allowed to treat previously randomized wounds (treated and control wounds) and new wounds, up to a max of 10 individuals wounds; there won't be control or randomized wounds. Participants might reapply up to once a week, and wound healing and safety will be assessed at the monthly visits. |
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical and/or genetic diagnosis of RDEB by a dermatologist
- Age 6 years or older willing and able to give consent/assent
- At least 6 wounds (3 wound pairs) each with an area of 10cm2 or greater located at any site (excluding face and genital skin)
- Wounds must be present for at least 4 weeks and able to be classified as recurrent wounds (wounds that heal within 12 weeks but then re-blister) vs chronic open (older than 12 weeks)
Key exclusion criteria (4 listed)
- Actively infected wounds with pus (colonized wounds are eligible)
- Wounds that have had squamous cell carcinoma (SCC)
- Wounds on the face and genitals
- Wounds that have been treated with investigational therapies in the past 3 months
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 |
|---|---|---|
| Spincare matrixThe Spincare device, developed by Nanomedic, is the first portable tool that delivers a non-invasive, non-therapeutic electrospun, nanofibrous matrix dressing to wounds to promote healing. | Device | Open-label Arm (extension), Randomized Arm |
Primary outcome
Number of Wounds With Greater Than 90% Wound Closure at 4 Months
Time frame: Baseline to month 4 of the randomized phase
The primary endpoint was comparison of the duration of wound closure of matrix-treated wounds vs control wounds measured as the number of wounds achieving greater than 90% wound closure within 4 months
5 secondary outcomes
Adverse Event Profile Characterization
Time frame: 4-month randomized period followed by 4-month open-label period
Change From Baseline in Wound Pain Scale Score Assessment
Time frame: months 1, 2, 3, and 4 of the randomized phase
Change in Wound Itch Scale Score Assessment
Time frame: months 1, 2, 3, and 4 of the randomized phase
Number of Wounds That Reach >50% Healing From Baseline Per Investigator Assessment
Time frame: months 1, 2, 3, and 4 of the randomized phase
Number of Wounds That Reach >70% Healing From Baseline Per Investigator Assessment
Time frame: months 1, 2, 3, and 4 of the randomized phase
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified coded data may be shared with collaborators, funding agency and presented at scientific meetings. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) would be shared.
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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.
Jean Y Tang, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spincare matrix in people with Recessive Dystrophic Epidermolysis Bullosa, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Wounds With Greater Than 90% Wound Closure at 4 Months (time frame: Baseline to month 4 of the randomized phase). 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 15 Sep 2025.