Abstract
Introduction: Acne has a significant negative impact on quality of life (QoL): lack of self-confidence, depressive symptoms and suicidal thoughts. The objective was to assess the impact of an initial and continued therapy in severe acne patients through patient-related outcomes (PRO). Methods: In two sequential double-blind randomized studies, patients received either adapalene 0.1% and benzoyl peroxide 2.5% (A–BPO) or vehicle, associated with doxycycline 100 mg for 12 weeks. Patients having obtained at least a good improvement according to investigator global assessment were re-randomized for a 24-week therapy with A–BPO or vehicle. PROs were assessed using the Acne-QoL and a patient treatment satisfaction questionnaire. Results: QoL was improved at week 12 in all domains with a significant difference for the Acne-symptoms domain (p < 0.001) in favor of the A–BPO regimen. Additional 24-week A–BPO treatment showed a sustained improvement, significant (p < 0.001) for all domains except for Acne-symptoms. In the vehicle arm, QoL significantly worsened for all domains (p < 0.03). At weeks 12 and 36, a significantly higher proportion of patients receiving A–BPO vs. vehicle reported high satisfaction for five out of six treatment satisfaction items. Conclusions: The early and sustained improvement of these PROs is correlated to the fast onset of action of A–BPO, the treatment effectiveness and a good safety profile.
Acknowledgments
The authors would like to thank the ACCESS I & ACCESS II investigators for their contribution.
Declaration of interest: These two studies were funded by Galderma R&D. Drs Brodell, Schlosser, Rafal, Toth and Tyring have served as investigators for Galderma R&D. Pr Wertheimer received a consulting fee for the scientific writing assistance. N. Kerrouche and D. Bucher are current employees of Galderma.