CODerm Research: 303.761.0906
(option 6)
Clinical Research
Colorado Center for Dermatology & Skin Surgery is committed to being at forefront of patient care including cutting-edge treatments through clinical research and clinical trials. Our research division, CODerm Research, is based in our Denver, Colorado Tech Center flagship office and is under the direction of Dr. Theo Alkousakis and Dr. Matt Mahlberg. We are dedicated to responsible research using the highest clinical practices and strict industry standards for safety.
Areas of research interest include psoriasis, atopic dermatitis, vitiligo and skin cancer. In addition, we work with laser and device companies to help develop new technologies for medical and cosmetic indications. Studies are open to current Colorado Center for Dermatology & Skin Surgery patients as well as patients who have never visited one of our locations.
Frequently asked questions:
You do not need to be a current patient at our practice to participate in a trial and you do not need to continue to be seen as a patient at our practice after a trial is completed, but you are free to do so if you chose. You may be referred by your current provider to be considered for a trial or you may contact our clinical research team directly.
Participating in a clinical trial may offer treatment options not yet generally available. Trial participation may potentially improve your specific skin condition or overall well being. Clinical trials and participating volunteers help advance our understanding of medical conditions and develop new treatments.
All information, including medical, personal or other information obtained during a clinical trial will remain confidential and is protected by state and federal regulations governing clinical research. Personal information will only be released with your authorization.
We list the general skin conditions or specific diagnoses that current or upcoming trials are focused on above.
Before participating in any trial, a clinical research coordinator will provide you with a detailed written and verbal description of the information you need to make an informed decision about joining a clinical trial. This process is known as informed consent. The consent form will include a detailed discussion of the following: potential risks and benefits; information about the study schedule and duration; and contact information for the physician and company sponsor overseeing the clinical trial. All clinical trials will adhere to a strict predetermined protocol that outlines exactly what will and may take place during the course of the study.
Many trials offer a patient stipend per visit. Please contact our research department or read about the trials we offer to find out whether or not a trial providers patient payment.
In some studies all medical care related to the clinical trial, including exams, laboratory tests and medications is provided at no charge to you. In other studies there is a reduced cost for participants. Certain clinical trials may also reimburse you a nominal flat fee to cover your travel and time expenses. Any costs or reimbursements would be covered as part of the informed consent before you join a trial.
The clinical research team uses specific inclusion and exclusion criteria to determine whether you are an appropriate candidate for a clinical trial. These criteria vary from trial to trial and are described in detail in the consent paperwork and study protocol. Inclusion criteria are characteristics that someone must have to join a clinical trial. Exclusion criteria are characteristics that someone cannot have in order to participate in a clinical trial.
Each clinical trial is different. This information will be provided to you in the consent paperwork. It may vary from a few months to over a year.
The length of each office visit may also vary significantly, depending on the study. The initial visit usually lasts 60-90 minutes, while subsequent visits usually shorter. Some studies include special testing at specified visits that may require waiting in our office for several hours between tests.
A board-certified dermatologist will diagnose you and/or offer medical advice. Both the physician and clinical research coordinators will determine if you are eligible for a specific clinical trial based on inclusion and exclusion criteria set by the sponsor.
Not all of our physicians participate in the clinical trials. Participating physicians vary per study. You will be able to continue to see your established physician for regular medical visits, but will see a physician participating in the study as an investigator for visits relating to the clinical trial. Clinical research appointments cannot be combined with any other type of patient visit.
You are free to cease participation in a clinical trial at any time and for any reason. Details about why you have decided to leave the study are appreciated but are not mandatory. Depending on the type of clinical trial, the clinical research team may offer you advice (i.e. if a study medication needs to be withdrawn gradually), but this is not required.
Interested in participating in a clinical trial?
Please contact us at (303) 761-0906, option 6 or email us at crcs@coloradodermatology.com with your name, phone number, date of birth and study of interest.
Sponsors
If you are interested in having CODerm running your study at our site please contact research@coloradodermatology.com.
