Skin research study for patients CURRENTLY ON Dupixent (Dupilumab) (San Francisco)
compensation:$500 Visa gift card
QR Code Link to This Post
We are looking for patients with atopic dermatitis (eczema) who are currently being treated with Dupixent (dupilumab) for a clinical research study. The purpose of this study is to better understand skin inflammation through molecular profiling of healthy and inflamed skin. Participation in this research study involves attending at least one in-person visit at UCSF where small skin biopsies and a blood draw (up to 40 mL) will be taken. For your inconvenience, you will receive a $250 Visa gift card for each biopsy (up to $500).
At the initial visit, you will have two 6 mm skin punch biopsies taken from the chest/abdomen/back area-- one from an area of eczema and one from nearby unaffected skin. For this procedure, a small area of skin will be cleaned with an alcohol pad and numbed by injecting an anesthetic into the skin. Afterwards, the 6 mm punch biopsies will be removed, and then the resulting break in the skin will be stitched which will need to be removed in 1-2 week’s time. A punch biopsy is where a small, tube shaped piece of skin and some other tissue underneath are removed using a sharp cutting tool. A skin biopsy is a common diagnostic test in a dermatology clinic; however, in this case, your skin biopsies will used for research purposes. A skin biopsy is a generally safe procedure, but complications can occur, including bleeding, bruising, scarring, infection and allergic reaction to the anesthetic.
In addition, a blood draw (~ 40 ml) will be performed using a standard venipuncture. These procedures will take a total of about 40 minutes time. Molecular experiments (such as looking at skin cell gene expression) will be performed on these samples to compare against diseased/inflamed skin and blood samples. ~2 weeks later, for removal of stitches, we can either use absorbable sutures which will not need removal (does not need follow up visit), can offer you a suture removal kit (to remove stitches at home yourself), or have a follow up in-person visit lasting a few minutes for us to remove the stitches. Donating specimens may involve a loss of privacy, but information about you will be handled as confidentially as possible.
These specimens will be used for genetic research (about diseases that are passed on in families). Even if we use the specimen for genetic research, we will not put the genetic research results in your medical record. The research will not change the care you receive. Your specimen and any information about you will be kept until it is used up or destroyed. It may be used to develop new drugs, tests, treatments or products. In some instances, these may have potential commercial value. Your personal health information cannot be used for additional research without additional approval from either you or a review committee. Genetic information (also known as genotype data) and the medical record data (also known as phenotype data) may be shared broadly in a coded form for future genetic research or analysis. We may give certain medical information about you (for example, diagnosis, blood pressure, age if less than 85) to other scientists or companies not at UCSF, including to a public access government health research database, but we will not give them your name, address, phone number, or any other identifiable information. Research results from these studies will not be returned to you.
There will be no direct benefit to you from allowing your specimens to be kept and used for future research. However, we hope we will learn something that will contribute to the advancement of science and understanding of health and disease.
To participate, you must be 18 to 70 years old with a physician-confirmed diagnosis of atopic dermatitis for at least one year and be currently receiving Dupixent (dupilumab) under your physician’s care.
You may not participate if you are/have:
• Unwilling and/or unable to complete informed consent process
• Less than 18 years of age
• Older than 70 years of age
• Severe illness(es) that may adversely affect the individual’s participation in the study (e.g.: HIV infection, autoimmune disease, poorly controlled cardiopulmonary disease, severe heart failure, history of malignancy (other than in situ cervical cancer or skin cancer, etc.))
• Recent bacterial, fungal, or viral infection requiring systemic therapies within the last 4 weeks.
• Use of other immunosuppressive or immunomodulators systemic medications (other than dupilumab) including phototherapy within the past 4 weeks
• Use of other biologic agents within the past 12 weeks
• Vaccination within the past 4 weeks
• Currently enrolled in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy and subjects undergoing treatment with another investigational drug or approved therapy for investigational use within 12 weeks prior to study participation
• History of keloid formation or allergy to lidocaine/novocaine or reaction to epinephrine
If you are interested in participating in our Dupixent eczema study, please email JASON.CHEN3 [at] UCSF.EDU with "On Dupixent" in the subject heading. Please include your phone number and the best time to reach you for a brief screening call.