New combo therapy aims to heal wounds in rare skin disease
NCT ID NCT06834035
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding IV IgG treatment to standard VYJUVEK therapy can help wounds heal faster and reduce blistering in people with recessive dystrophic epidermolysis bullosa (RDEB), a rare genetic skin condition. Eight participants will receive IV IgG alongside their usual VYJUVEK treatment. The goal is to see if this combination reduces wound size and improves quality of life.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 8 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Diagnosis of generalized Recessive dystrophic epidermolysis bullosa (RDEB) demonstrated by COL7A1 mutations. 2. Diagnosis of EBA demonstrated by the presence of levels of serum C7 antibodies above the normal ELISA range 3. Baseline skin blistering greater than 5% total body surface area 4. 1 wound at least 20 cm\^2 able to be entirely treated with Vyjuvek weekly 5. 1 wound at least 20 cm\^2 that has never been treated with Vyjuvek 6. Ongoing VYJUVEK treatment. Exclusion Criteria: 1. History of thrombotic event(s) 2. History of cardiac failure 3. History of renal failure 4. IgA deficiency
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Stanford University
RECRUITINGRedwood City, California, 94163, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Gene therapy for 'Butterfly Skin' disease tracked for 15 years in major safety registry
- Anti-Inflammatory drug may ease swallowing in rare skin disease
- Turmeric and blue light may heal blisters in rare skin disease
- New eye drop battle: which offers better dry eye relief?
- New hope for blistering skin diseases: drug targets antibodies to heal wounds
- Stanford launches study to better understand rare blistering skin disease