Online Clinical Trial for Cold Sores
Author Information
Author(s): Margaret Formica, Karim Kabbara, Rachael Clark, Tim McAlindon
Primary Institution: Tufts-New England Medical Center
Hypothesis
Can clinical trials requiring frequent participant contact be effectively conducted over the Internet?
Conclusion
The study demonstrated that while participant recruitment and retention were high, adherence to the study protocol was low, indicating challenges for future Internet-based trials.
Supporting Evidence
- 292 individuals applied to the trial, with 182 screened eligible.
- 32 participants with confirmed herpes labialis enrolled in the trial.
- 91% of participants completed the trial.
- The DSS treatment group had a statistically significant lower mean pain score compared to the placebo group.
Takeaway
This study tested a cold sore treatment online and found it was easy to get people to join, but many didn't follow the rules about using the treatment.
Methodology
A 6-month, double-blind, randomized, placebo-controlled trial with online questionnaires and topical treatment application.
Potential Biases
Participants were all Internet users, which may limit the generalizability of the findings.
Limitations
Participant adherence to the daily outbreak visit schedules was low, and many missed visits occurred during weekends and holidays.
Participant Demographics
Mean age of participants was 43, with 72% female and all participants being Caucasian.
Statistical Information
P-Value
P= .04
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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