Journal of Clinical and Aesthetic Dermatology

MauiDerm Abstract Supplement 2016

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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S U P P L E M E N T T O T H E J O U R N A L O F C L I N I C A L A N D A E S T H E T I C D E R M AT O L O G Y [ M AY 2 0 1 6 • V O L U M E 9 • N U M B E R 5 ] S 6 t rustworthiness in men, and because submental fullness can give the appearance of being overweight and/or older, this new injectable treatment may be of interest to men. This post- h oc analysis examined the efficacy and safety of ATX-101 in men who participated in the Phase 3 REFINE trials. Methods: REFINE-1 ( NCT01542034) and REFINE-2 (NCT01546142) were identical double- blind, placebo-controlled trials conducted in the United States and Canada. Adults with moderate (grade 2) or severe (grade 3) SMF (based on both investigator and subject assessment using the Clinician- Reported SMF Rating Scale [CR- SMFRS] and Patient-Reported SMF Rating Scale [PR-SMFRS], respectively) who were dissatisfied with their submental region were randomized to ATX-101 2mg/cm 2 or placebo for up to six treatments. The co-primary endpoints, composite ≥1-grade and ≥2- grade response based on both CR- SMFRS and PR-SMFRS were evaluated at 12 weeks after last treatment. Secondary endpoints were change in the psychological impact of SMF (using the Patient-Reported SMF Impact Scale [PR-SMFIS]) and percentage achieving a prespecified reduction in submental volume by magnetic resonance imaging (MRI) in a subset of subjects. Satisfaction with the appearance of their face/chin and with treatment were assessed using the Subject Self-Rating Scale (SSRS) and Subject Global Question (SGQ-3), respectively. Results: Of the 1,022 subjects enrolled in the REFINE trials, 156 (15.3%) were men (ATX-101, n=80; placebo, n=76). The mean (SD) age of the men was 47.0 (10.5) years with mean (SD) body mass index of 29.6 (3.5) kg/m 2 . Overall, 91.7 percent of men were white, 60.3 percent were CR-SMFRS grade 3, 35.9 percent were PR-SMFRS grade 3, and 74.4 percent were Fitzpatrick skin type I–III. The co-primary endpoints (composite ≥1- grade and ≥2-grade response) in men receiving ATX-101/placebo were: 64.4%/8.6% (p<0.001) and 9.6%/0 (p=0.014), respectively. Overall, 32.5 percent of ATX-101–treated men were M RI responders versus 2.9 percent of placebo-treated men (p<0.001). At baseline, men demonstrated psychological impact from their SMF, with PR-SMFIS scores of 6.9 and 6.8 ( 10=most impacted) in the ATX-101 and placebo groups, respectively. The mean change from baseline in PR- SMFIS at 12 weeks after last treatment was -3.0/-0.9, respectively (p<0.001). M ost men were satisfied with their face/chin and treatment; 79.2 percent of ATX-101–treated subjects versus 22.9 percent of placebo-treated subjects were SSRS responders (p<0.001) and 71.4 percent versus 24.3 percent, respectively, were satisfied with treatment based on SGQ- 3 (p<0.001). Overall, 96.3 percent of ATX-101–treated men and 78.9 percent of placebo-treated men reported an adverse event (AE); most AEs were localized to the treatment area, mild/moderate, and transient. The most common AEs in men receiving ATX-101/placebo were: edema (swelling), 90.0%/38.2%; anesthesia (numbness), 75.0%/2.6%; bruising (hematoma), 67.5%/42.1%; and pain, 63.8%/22.4%. Conclusion: This post-hoc analysis of pooled REFINE data illustrates that ATX-101 effectively reduced SMF in men with ≥50-percent reduction in the psychological impact of SMF. Importantly, men were satisfied with their face/chin and with treatment. Overall, the ATX-101 treatment effect and safety profile observed in men was similar to that seen in women. Changes in Skin Laxity Among Responders to ATX-101 (Deoxycholic Acid Injection) in the REFINE Trials Presenters: 1 Sabrina Fabi; 2 Zoe Draelos; 3,4 Steven H. Dayan; 5 Todd M. Gross; 5 Paul F. Lizzul; 5,6 Frederick C. Beddingfield, III; 5 Christine Somogyi Affiliations: 1 Private practice, San Diego, CA; 2 Private practice, High Point, NC; 3 University of Illinois, Chicago, IL; 4 Private practice (SDMD), Chicago, IL; 5 Allergan plc, Irvine, CA; 6 David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA Background: ATX-101 ( deoxycholic acid injection) was recently approved as a pharmacologic treatment for submental fat (SMF) reduction. When injected into subcutaneous fat, ATX-101 causes a dipocytolysis (targeted destruction of fat cells) and an expected local tissue response which may involve collagen production (neocollagenesis). Data from clinical trials, including the two P hase 3 REFINE trials, demonstrated that ATX-101 significantly reduced SMF based on investigator and subject assessment as well as objective assessment via magnetic resonance imaging (MRI; evaluated in a subset of subjects). In a pooled analysis of the REFINE data, 68.2 percent of ATX- 101–treated subjects and 20.5 percent of placebo-treated subjects (p<0.001) had a composite ≥1-grade response based on both investigator and subject evaluation. The MRI response rate (prespecified reduction in submental volume) was 43.3 percent and 5.3 percent in ATX-101–treated and placebo-treated subjects, respectively (p<0.001). A composite ≥2-grade response based on both investigator and subject evaluation was seen in 16.0 percent and 1.5 percent of subjects, respectively (p<0.001). In theory, SMF reduction could result in worsened skin laxity, as seen in some patients undergoing liposuction for SMF removal. However, skin laxity was unchanged or improved in 93.4 percent of ATX-101–treated subjects in the REFINE trials despite significant SMF reductions. To further explore the effect of SMF reduction with ATX- 101 treatment on skin laxity, a post- hoc analysis was conducted to evaluate the change in skin laxity among treatment responders in the REFINE trials. Methods: REFINE-1 and REFINE-2 were identical randomized, double- blind, placebo-controlled trials (NCT01542034 and NCT01546142). Adults with moderate or severe SMF (based on both investigator and subject assessment) who were dissatisfied with their submental region were enrolled. Skin laxity was assessed as a safety measure using the 4-point Submental Skin Laxity Grade (SMSLG) scale (1=none) and subjects

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