Double-Blind Study


In 1998-99, Professor Loic Vaillant of the Department of Dermatology in the Faculty of Medicine in Tours, together with Dr. Deheuvels and eight independent physicians, undertook a double-blind clinical trial, producing a report entitled “Study of the Effects of Effects of ‘predicate thermal therapy device’  that utilized Topical Heatin in Recurrent Peri-buccal Herpes”. The study was a randomized, cross-over double-blind study, comparing the effectiveness of the Predicate thermal therapy device in treating cold sores with the results of a visually identical placebo device, to deliver verifiable cold sore facts via the study. The study involved a total of 47 patients at ten separate investigation centres. All patients had a history of recurrent cold sores, with a minimum of 4 outbreaks in the previous 12 months.

Study participants were randomly given either a Predicate device or a visually identical placebo unit that would not generate sufficient heat to be therapeutically effective, and were asked to use the device for three 30-second applications at 5 minute intervals during the first three hours of the prodromal phase of potential cold sore outbreaks. They were given a self-report notebook to record their experiences and a disposable camera with which to take before and after photographs of the affected area. Each patient participated in two separate 4-6 month study phases, receiving the opposite type of device for the second phase. Thus, each patient was observed while using both the Predicate thermal therapy device and the placebo. At the end of each phase, the patients completed a questionnaire and met for a consultation with the investigating physician.

The results of the randomized double-blind placebo-controlled study statistically demonstrate the effectiveness of Predicate provided it is used within 3 hours of the early prodromal phase of the disease, before the occurrence of blisters. The results also demonstrated that if the Predicate device was applied beyond the optimal conditions then the effectiveness of Predicate was reduced. Moreover, the study found that Tolerance to [the thermal therapy device] does not significantly differ from placebo. Acceptability of the treatment was total in almost all cases.

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