Abstract
Objectives: This survey program was designed to evaluate patients' experiences with doxycycline, USP, 40 mg capsules (30 mg immediate release, 10 mg delayed release beads, ORACEA®; Galderma Laboratories, L.P.) as a treatment for the inflammatory lesions of rosacea and to provide patient-reported feedback to physicians.
Methods: This prospective, cross-sectional survey was implemented in January 2010. One thousand, two hundred and ninety-five physicians
identified patients eligible for treatment with doxycycline, USP, 40 mg capsules and provided them with information about the program.
Patients voluntarily participated by contacting a program coordinator or by enrolling online, providing consent, and responding to a series of questions prior to medication use and approximately four weeks post-treatment initiation. Surveys were completed through an automated interactive voice response system or a dedicated, secure website and included questions regarding patients' perceptions of when the treatment first started working, patients' symptom severity, interference of symptoms with work and social activities, and confidence
in appearance. Patients were also asked about prior medication use, adjunct medication use, and treatment satisfaction. Reports of patient progress and responses to these survey questions were sent directly to each patient's treating physician within a few days of survey completion. Paired t-tests were used to evaluate the statistical significance of differences in symptom severity, interference and confidence ratings before and after treatment.
Results: Two thousand, eight hundred ninety-eight patients enrolled in the survey program and completed the baseline survey. Of these, a total of 1,346 patients completed the baseline and four-week survey (mean age 50 years; 75% female). Most (58%) reported use of a prior prescription medication to treat rosacea. Over half the patients (52%) responded that the product began to work within two weeks of use. After four weeks of using doxycycline, USP, 40 mg capsules, patients felt that the severities of redness as well as bumps/blemishes were significantly reduced (P<.05). Patients also reported having more confidence with their skin's appearance (P <.05). In addition, with use of doxycycline, USP, 40 mg capsules, patients reported significant reductions in the interference of symptoms with work and social activities (P<.05). Satisfaction with doxycycline, USP, 40 mg capsules averaged 6.8 on a scale of 1 (not at all satisfied) to 9 (very satisfied) for patients using only doxycycline, USP, 40 mg capsules; mean satisfaction was 6.7 for those using it with adjunct medication. Seven patients reported 11 adverse events during the program, including lack of efficacy, joint injury with fatigue, dizziness, back pain, bloating and constipation, increased facial redness and pimples, yeast infection, sore throat, increased bruising and worsening of rosacea.
Conclusion: Satisfaction with doxycycline, USP, 40 mg capsules for the treatment of papulopustular rosacea was apparent from patient-rated measures of treatment impact. Patients with papulopustular rosacea reported improvement in symptoms, reductions in the interference
of symptoms with life's activities and satisfaction with treatment with doxycycline, USP, 40 mg capsules.
J Drugs Dermatol. 2011;10(12):1376-1381.
