A community-based study of the effectiveness of doxycycline 40 mg (30-mg immediate-release and 10-mg delayed-release beads) on quality of life and satisfaction with treatment in participants with rosacea
Baldwin, H.E.
Cutis 86(5 Suppl): 26-36
2010
ISSN/ISBN: 0011-4162 PMID: 21229828 Document Number: 644359
Changes to the skin of the face in patients with rosacea have the potential to substantially impair multiple domains of quality of life (QOL); however, the number of publications providing evidence for this topic is limited. This 12-week, open-label, community-based, phase 4 trial of 1421 participants is the largest study of the disease to date. It explores the effects of mild to severe rosacea and its treatment on QOL. Participants were treated with doxycycline 40 mg (30-mg immediate-release and 10-mg delayed-release beads) as monotherapy or add-on treatment to existing topical therapy. This article examines QOL issues in the primary analysis population consisting of 966 participants who completed the trial without a major protocol violation. Quality of life was assessed at baseline and study end (week 12) with the RosaQoL, a validated 21-question instrument. Participant and investigator satisfaction with treatment also were evaluated. In the monotherapy group, the mean RosaQoL score was 3.3 at baseline and 2.8 at end of study. In the add-on therapy group, the mean RosaQoL score was 3.2 at baseline and 2.8 at end of study. The improvement in QOL was both clinically and statistically significant (P < .0001) and was similar in both monotherapy and add-on therapy groups. Most participants expressed satisfaction with treatment and approximately 90% of the community-based investigators reported that they were likely or very likely to continue prescribing this formulation. The study demonstrates that the impaired QOL in patients with rosacea can be substantially improved during a 3-month period by once-daily treatment with the anti-inflammatory activity of subantimicrobial-dose doxycycline.