Topline results of DREAM (Dysport Real-world Evaluation and Measured satisfaction study), a clinical study of Dysport (abobotulinumtoxinA) for injection, showed that 95 percent of patients treated with Dysport achieved high levels of satisfaction with two treatments per year, and 97 percent of patients thought the result of the treatment looked natural, according to Galdmera. 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.
“As a physician in practice for nearly two decades, I have many long-standing patients who come in for retreatment with neuromodulators every three to four months. In the DREAM study, we were interested in evaluating patient satisfaction with a regimen in which Dysport was administered on a twice-yearly schedule,” says Joel L. Cohen, MD, a board-certified and fellowship-trained dermatologist and Director of AboutSkin Dermatology and DermSurgery in Colorado, and an investigator for the DREAM study. “We were encouraged to find in this Phase 4 study that close to 100 percent of patients were satisfied or highly satisfied with the aesthetic results of treating the lines between their eyebrows every six months for a year with Dysport. These top-line results suggest that aesthetic specialists can feel confident administering injections that match patient goals of treatment efficacy from every three to four months to a twice-yearly schedule.”
DREAM Study Design and Results
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 percent were female and one-third (33 percent) 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 percent of patients were satisfied (35 percent) or highly satisfied (60 percent) at 12 months.
97 percent of the 35 patients who were toxin-naive and 93 percent of the 75 patients who had been previously treated with a toxin were satisfied/highly satisfied at 12 months.
97 percent of patients agreed that the treatment result looked natural at 12 months.
85 percent of patients were satisfied/very satisfied with their appearance at 12 months compared with 51 percent at baseline (i.e., before receiving an injection).
84 percent of patients were satisfied/very satisfied with the aesthetic outcome in the treated area at 12 months.
98 percent of patients agreed that “I am accepting of myself” and 94% of patients agreed that “I feel confident” at 12 months.
98 percent of patients would like to receive the same treatment again at 12 months
97 percent 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).
“Today’s announcement underscores our commitment to growing the aesthetic market and continuing to drive innovation so that patients can embrace injections with confidence,” said Alexandre Brennan, Global Business Unit Head Aesthetics, Galderma. “We are thrilled with the top-line findings from the DREAM study demonstrating high levels of patient satisfaction and natural-looking results with Dysport when given twice a year. We anticipate publishing full results from DREAM, the first clinical study to evaluate this treatment schedule, in the coming months.”
GAIN Live Webinar on DREAM Details
As part of Galderma’s GAIN (Galderma Aesthetic Injector Network) live webinar series for aesthetic specialists, the company is hosting a webinar on the DREAM study featuring study investigators Dr. Joel Cohen and Dr. Carolyn Jacob tomorrow, Wednesday, May 13, at 7 pm CDT. To register, visit https://webinars.gainhcp.com/index/useraccess and use access code “GAINweb2020.”