Managing The Infection To Prevent Relapse
Dr. Malay: Various studies have reported relapse rates of onychomycosis. The Tosti study from 1998 showed a 22 percent relapse after three years.5 In the Heikkila and Stubb study from 2002, they showed the relapse rate being as high as 66 percent.6 There was also information from Jansen, et. al., in PharmacoEconomics in 2001 that showed a 53 percent relapse rate for onychomycosis.22 In a 2002 study published in Archives of Dermatology, Sigurgeirsson, et. al., found that the relapse rate was in the range of 50 to 55 percent. So it’s certainly a problem.23
Anecdotally, I had a patient who came in after having onychomycosis for 20 years. He was 67 and had well-controlled diabetes and satisfactory circulation. This gentleman didn’t like to show his toes when he went to the beach. The patient had seen another practitioner who recommended a course of oral therapy and the patient was very happy with the therapy that appeared to cure his onychomycosis. However, a year and a half later, he was presenting to me with onychomycosis. This gentleman was depressed and frustrated to say the least.
This patient’s case is a good example. I believe that patients who have gone through this treatment to “cure onychomycosis” should subsequently use some form of topical therapy to prevent de novo reinfection or exacerbation of a sub-totally cured condition. I have my patients put on topical ciclopirox lacquer twice a week. They are willing to do it if they have had a cure, have been satisfied with it and want to maintain it.
Dr. Malkin: I couldn’t agree more. I tell patients I can’t guarantee that putting a prescription antifungal solution on the nail is going to prevent relapse, but it’s the best thing we have right now. I set them up for the possibility that they still may get a second infection. Do you routinely mycologically culture a patient at the end of treatment?
Dr. Malay: Not routinely. However, I’m looking for clinical signs of improvement and patient satisfaction and my own satisfaction with the appearance and the function of the nail. If we were to do a distinct study, then obviously we would have to define the outcomes. You would have a soft endpoint like improvement, patient satisfaction and that the nail looks good and it functions well. Then you would also have a hard endpoint such as microscopic inspection and/or culture sensitivity for fungus.
It has been done partially in different studies, but to look at this question of relapse or reinfection, it is going to take a long time and it is going to take a statistically properly powered number of patients being followed within a cohort study over time. You are probably going to have to do this for a minimum of a five- to 10-year period. It is costly and difficult.
Dr. Cervantes: That’s when prophylactic measurements come into play. I think that is the key. If you accomplish a clinical improvement and satisfaction, the patient is happy and you are happy. Now the key is to keep that satisfaction level for the next 10 to 15 years. Just like you said, if the patient applies ciclopirox once or twice a week, he or she will be happy. It eliminates the high cost and potential risk of oral antifungal medications.
Dr. Malay: Using that small bottle of topical twice a week on specific nails goes a long way. It’s been shown that treating in combination is cost effective, and it makes sense intuitively to maintain some type of defense against relapse or reinfection.
Where Shoe Gear And Clean Showers Come Into Play
Dr. Malkin: Getting back to your patient, did he simply want to go back to the way it was?
Dr. Malay: He certainly wanted to be treated again. The issue was how to prevent it from coming back. There are other aspects of this and they deal with shoe gear. When I start patients on a course of treatment, I tell them from day one that they need to either change their shoes or wash the shoes in diluted bleach. You can often do that and let the shoes air dry. They can also maintain their other shoes and treat other shoe gear with some type of spray or powder antifungal on a periodic basis.
Dr. Malkin: In my mind, you begin treatment, but the patient is going to reinfect that shoe because he or she is not cured yet so to speak. I wonder whether you should wait to change shoes toward the end of treatment when there is no fungus left in the nail to reinfect the shoes.
Dr. Cervantes: Shoes are important, but we must remember that this organism is found on wet surfaces. The shower is the main source of this reinfection. I instruct my patients to spray the shower walls and the floor with bleach before they take a shower. I tell them to irrigate that with cold water so they don’t irritate their eyes. I tell them to use the bleach again after they shower. So you would irrigate with bleach beforehand to protect yourself and after you take a shower so you can protect the next person in line. I think this type of regimen will eliminate the recurrence and also prevent the infection from spreading among family members.
Dr. Malay: This is obviously anecdotal and it makes sense, but this kind of thing would be extremely hard to study. Getting people to change how they clean their bathroom and how they handle their shoe gear really would be tough from a compliance standpoint in a control study.
Dr. Cervantes: I would be interested to spray the shower walls and then take a culture before and after.
Dr. Malay: It is still asking certain patients to do more than they are going to do. From an education standpoint and a management standpoint with the thought of preventing relapse or reinfection, it is important. I think we are obligated to talk about it with the patient.
Dr. Joseph: This goes back to the whole concept of not only managing the pathogen but also managing the environment. In order to manage reinfection, we need to manage the pathogen with, let us say, topical ciclopirox lacquer twice a week, and we also need to manage the environment with all the things we have just discussed.