About
With the discovery of many new treatments, we are now offering a variety of different clinical trials for vitiligo patients. These clinical trials offer patients the opportunity to try the newest drugs that are being developed and to contribute to discovering and testing them; thus, changing the future of vitiligo treatment.
Clinical trials differ from common medical care. Within a clinical trial, a small group of participants are subjected to a new drug. This new trial is then closely monitored by clinicians to study the effects of the new treatment on participants. Due to the commitment and length, entering a clinical trial is not for everybody. While it can be very exciting, patients should think about the implications including: multiple visits during the trial, schedule, anxiety about using a new treatment, and other potential factors that may hinder commitment.
While some trials have been conceived, designed, and implemented by the Vitiligo Clinic and Research Center at the UMass Chan Medical School directly, many are sponsored by pharmaceutical companies to test their drugs. The Clinic frequently consult for these companies to help develop the protocol for the trial (how they are conducted), but do not have ultimate responsibility for them. Additionally, the Clinic receive payments from the companies who run the trials, and thus a potential conflict of interest exists between running the trial, treating our patients, and writing about how they may impact the future of vitiligo. We always do our best to manage this potential conflict and not let it change the way that we take care of our patients or how we educate the public.
The Process
Clinical trials take a long time to plan in order to be done well, ensure the safety of the participants, and ultimately give a clear answer about whether a treatment works for the disease or not. Thus, clinical trials are expensive to run and require a lot of funding. Once the planning is complete, it must be approved by the Institutional Review Board (IRB) at the UMass Chan Medical School and other participating institutions to ensure the safety of participants. Following approval, the trial is announced and recruiting subjects to participate can begin through word of mouth, dermatologist referrals, advertising, our website, and newsletter notifications.
Once patients reach out with interest, they are informed about the details of the study including what the drug is and how it's taken (topical, oral, injectable, etc.), the likelihood of getting the drug (some trials have a placebo and are blinded, so you have a chance of entering the trial and not getting the drug to be tested), how many visits are required, and how long the trial runs. Additionally, potential subjects are informed about inclusion and exclusion criteria, which list the exact type of person for the trial. This often includes an age range, where the vitiligo is located on the body, how much vitiligo a patient has, how long a patient has had it, other medical conditions a patient has, etc.
Once the potential subject has been informed about the inclusion and exclusion criteria, decide that they're still interested in the trial, and fulfill all of the detailed criteria, they are scheduled for a screening visit. This visit includes an examination and lab tests to make sure that they are healthy for the trial. If the results of this visit are positive, the potential subject is enrolled in the trial, visits are scheduled, and if applicable, they are randomized and given the drug or placebo to use.