Dr. Graber's Research Grant Project

Emmy Graber, MD
Boston University School of Medicine
2011 Research Grant Recipient


Research Grant Proposal

Patient and Parent Attitudes towards Isotretinoin: Both Before and After Treatment

Study sponsor: Diane Thiboutot, MD, FAAD

Abstract: Oral isotretinoin is the most effective acne medicine available and is the only available medicine to cure patients of acne. Despite this truth, patients and their parents are often leery to start isotretinoin, even more so with the media stories reporting the negative side effects of isotretinoin.  Many of these stories are based on rare, isolated incidents and do not reflect the typical patient's experience with isotretinoin.  Regulatory committees have also shown their concern over isotretinoin.  Due to the teratogenicity of isotretinoin, the US Food and Drug Administration has recently required strict regulation of the drug through the iPledge system.  Isotretinoin induced fetal harm and anecdotal reports of possibly unrelated adverse events may promopt tighter federal regulation or market withdrawal of isotretinoin.  The loss of isotretinoin would be devastating, as patients would no longer have a cure for their acne.

Studies have been performed to attempt to negate the link between isotretinoin and negative side effects.  While these studies are important, other studies are needed to demonstrate the positive experience that the majority of patients have with isotretinoin.  The aims of this study, in addition to trying to disprove the negative side effects, are to prove the positive aspects of isotretinoin by quantifying patient and parent attitudes toward isotretinoin before and after treatment.  Demonstrating high patient and parent satisfaction rate with isotretinoin will: 1) encourage future patients to seek treatment and 2) dissuade regulatory committees to potentially withdraw isotretinoin from the market.  This will be accomplished by giving both patients and their parents questionnaires to complete at the visit in which patients are enrolled in the iPledge program.  This questionnaire will capture feelings and thoughts regarding isotretinoin and the source of information by which patients and parents obtained these ideas.  Questionnaires will also be completed once the isotretinoin course has been finished.  With this questionnaire, patients and parents will be asked about any side effects encountered and their satisfaction with the treatment.