Galderma Announces Top-Line Results of Clinical Study Showing Patients Treated with Dysport® (abobotulinumtoxinA) Achieved High Levels of Satisfaction and Natural-Looking Results with Two Treatments Per Year
Lausanne, Switzerland – (May 12, 2020) Written by Isabella Laihorinne Smedh, PR & Communications on May 12, 2020. . For more information, please visit www.galderma.com.
Galderma today announced results of DREAM (Dysport Real-world Evaluation and Measured satisfaction study), a clinical study of Dysport®* (abobotulinumtoxinA) for Injection that evaluated patient satisfaction and safety with a twice-yearly treatment schedule. Top-line results showed that 95% of patients treated with Dysport achieved high levels of satisfaction with two treatments per year, and 97% of patients thought the result of the treatment looked natural.1 Dysport is a prescription injection for temporary improvement in the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults less than 65 years of age.
DREAM Study Design and Results1
The open-label, multicenter, interventional Phase 4 DREAM study enrolled 120 patients ages 18 to 65 with moderate to severe glabellar lines at maximum frown. Of those, 90% were female and one-third (33%) were toxin-naïve. The primary objective of the study was patient satisfaction, which was assessed by directly questioning study participants at 12 months and giving them the option of responding with “highly satisfied,” “satisfied,” “dissatisfied,” or “highly dissatisfied.” Secondary objectives included patient satisfaction as assessed by the 5-point Likert questionnaire and the FACE-Q scales measuring subject's psychological function and appraisal of lines between the eyebrows. DREAM was conducted at six sites in the United States. Patients were followed for 13 months to evaluate safety.
After receiving Dysport injections at the start of the study and then six months later, patients were assessed six months after that (12 months after the study began). Key top-line results of this study are as follows:
- 95% of patients were satisfied (35%) or highly satisfied (60%) at 12 months.
- 97% of the 35 patients who were toxin-naive and 93% of the 75 patients who had been previously treated with a toxin were satisfied/highly satisfied at 12 months.
- 97% of patients agreed that the treatment result looked natural at 12 months.
- 85% of patients were satisfied/very satisfied with their appearance at 12 months compared with 51% at baseline (i.e., before receiving an injection).
- 84% of patients were satisfied/very satisfied with the aesthetic outcome in the treated area at 12 months.
- 98% of patients agreed that “I am accepting of myself” and 94% of patients agreed that “I feel confident” at 12 months.
- 98% of patients would like to receive the same treatment again at 12 months
- 97% of patients would recommend this treatment to friends and family at 12 months
*Only one patient (0.8%) experienced a treatment-related adverse event (mild injection site bruising).
In short, 2 treatments per year yielded better satisfaction results compared to Botox treatments twice a year.