inherited epidermolysis bullosa
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Subjects (or guardians) voluntarily sign the informed consent of the trial; 2) Patients with hereditary epidermolysis bullosa (hereditary epidermolysis bullosa) who are older than or equal to 2 years old and younger than or equal to 80 years old, regardless of gender; 3) Patients with moderate to severe itching, itching score > 6, and IgE increased; 4) Subjects were able to follow the drug dosage and visit plan; 5) Can objectively describe symptoms, no serious infection, respiratory insufficiency, etc., can actively cooperate; 6) Non-allergic diseases and non-allergic constitutions; 7) Contraindicated patients with non-Omazumab drugs; 8)
Exclusion criteria
Exclusion criteria: 1) those with asthma, allergic rhinitis and milk allergy; 2) The general situation is poor, and the symptoms can not be described objectively, or there are serious infections, respiratory insufficiency, etc. can not cooperate actively; 3) Patients with severe respiratory system, cardiovascular system diseases, liver and kidney dysfunction and malignant tumors; 4) Patients with allergic reaction to the active ingredient of Omazumab or any other excipient (the active ingredient is Omazumab; the excipients include sucrose, L-histidine, L-histidine hydrochloride monohydrate and polysorbide 20); 5) Patients with total IgE 1 500 IU/ml; 6) suspected or confirmed history of drug abuse and addiction; 7) Lactating and pregnant women: subjects (including male subjects) who had no pregnancy plan within one month after the trial; 8) Patients who had participated in the drug test within 3 months before the trial (including the drug in the trial); 9) Bidders or researchers directly involved in the experiment or their family members; 10) Researchers believe that there are any reasons why they cannot be selected.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Itching score;Itching score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Anxiety and depression score;Anxiety and depression score; | — |
Countries
China
Contacts
Xinhua Hospital, Shanghai Jiaotong University School of Medicine