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| Name | Class |
|---|---|
| Epidermolysis Bullosa Research Partnership | OTHER_GOV |
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The study objective is to see if IV IgG treatment in Recessive Dystrophic Epidermolysis Bullosa (RDEB) skin in conjunction with VYJUVEK treatment improves wound healing and affects the levels of C7 and HSV-1 antibody levels in serum.
Fewer wounds, more rapidly healing wounds, and decreased C7 and HSV-1 antibodies could improve quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intra-Personal Control | Experimental | There is one arm of the study. First, each participant undergoes a 3-month observational period, during which they continue application of their prescribed Vyjuvek. After 3 months, they enter the treatment period, during which they continue their Vyjuvek application and, in addition, receive the IV IgG treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunoglobulin G | Biological | Purified IgG from human serum, delivered via IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events and Effects | Occurrence of adverse events and effects | 9 Months |
| Percent Change in Wound Area | The wound area at the end of the treatment phase compared to the wound area at the beginning of the treatment phase. Wound healing (% and cm^2) over the course of the treatment phase compared to the wound healing (% and cm^2), over the observation phase. | 9 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kunju Clinical Research Coordinator, PhD | Contact | 650-721-4902 | kunju@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Matt P Marinkovich, MD | Associate Professor of Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Redwood City | California | 94163 | United States |
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| ID | Term |
|---|---|
| D004820 | Epidermolysis Bullosa |
| D016107 | Epidermolysis Bullosa Acquisita |
| D016108 | Epidermolysis Bullosa Dystrophica |
| ID | Term |
|---|---|
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
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| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| ID | Term |
|---|---|
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| D030342 | Genetic Diseases, Inborn |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012872 | Skin Diseases, Vesiculobullous |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |