Clinical efficacy and tolerability of a hydroquinone-free and retinol-free topical brightening serum on females with facial melasma

Clinical efficacy and tolerability of a hydroquinone-free and retinol-free topical brightening serum on females with facial melasma

Presenters: Makino ET, Tan P; Mehta RC

Affiliation: Research & Development SkinMedica, an Allergan Company, Irvine, CA

Background/Objective: Melasma, a progressive form of hyperpigmentation, occurs more often in healthy women than men. The actual etiology is indefinite; however, pregnancy, hormonal changes, ultraviolet (UV) light exposure, photosensitizing medications, and genetic predisposition have all been considered as contributing factors. This dysfunction of the pigmentary system results in symmetric brown or gray-brown patches on sun exposed areas of the face, particularly on the forehead, cheeks, upper lip, and chin. Often, the psychosocial impact of melasma leads to a negative effect on quality of life and emotional well-being. The purpose of this study was to assess the cosmetic efficacy and tolerability of a HQ-free and retinol-free serum (LYT2) in nonpregnant women with mild-to-severe melasma that was self-perceived as being induced by a previous pregnancy.

Methods: This was a 12-week, single-center, clinical usage study with visits at baseline and Weeks 4, 8 and 12. Thirty female subjects aged 30 to 50 years with Fitzpatrick Skin Types (FST) II to IV presenting with mild-to-severe overall hyperpigmentation on the face due to melasma, which was self-perceived to be induced by a previous pregnancy, completed the study. Seventy-three percent of the subjects were Caucasian, 20 percent were Asian, and seven percent were African American. All subjects received LYT2, cleanser, moisturizer, and sunscreen. Subjects applied LYT2 twice-daily after cleansing. All subjects used cleanser and moisturizer twice-daily and a physical sunscreen once in the morning (and as needed throughout the day). At all visits, the investigator assessed for overall hyperpigmentation (0–9 scale; 0=none, 1–3=mild, 4–6=moderate, 7–9=severe), global Improvement in Overall Hyperpigmentation (0–5 scale), and Melasma Area and Severity Index (MASI). Each subject’s face was divided into four areas that were evaluated separately (forehead [F], right malar region [MR], left malar region [ML], and chin [C]). For each area, the pigment intensity (PI), lesion size (A), and homogeneity (H) were assessed. MASI score for the whole face was calculated using the following equation: MASI=0.3 (PIF + HF) AF + 0.3 (PIMR + HMR) AMR + 0.3 (PIML+ HML) AML + 0.1 (PIC + HC) AC. The values 0.3, 0.3, 0.3, and 0.1 represent the respective percentages of total facial area. The maximum score for MASI is 48 and the minimum score is 0. Tolerability assessments for erythema, scaling, edema, burning, stinging, and itching were graded on a 4-point scale at all visits. At all follow-up visits, subjects completed a self-assessment questionnaire on self- perceived efficacy, product texture, and product attributes. At baseline and Week 12, subjects completed a Melasma Quality of Life (MelasQol) Questionnaire (Likert Scale: 1=not bothered at all to 7=bothered all the time).Standardized digital photographs were taken using the VISIA-CR Imaging System (Canfield Imaging Systems) at all visits. Image analysis on a target dark spot for skin brightness (L*) was conducted for each time point. Corneometer and tewameter measurements were conducted for all visits.

Results: The HQ-free and retinol-free serum demonstrated a statistically significant decrease in clinical grading scores at Weeks 4, 8, and 12 when compared with baseline for overall hyperpigmentation, global improvement in overall hyperpigmentation, and MASI (all p<0.001; Wilcoxon Signed-Rank Test). Statistically significant increase in mean scores for global improvement in overall hyperpigmentation at all visits (all p<0.001; Wilcoxon Signed-Rank Test). MelasQol Combined Score showed a statistically significant improvement at Week 12 compared to baseline, indicating an increased perception of quality of life (p<0.03; Wilcoxon signed-rank test). Corneometer and tewameter measurements continuously improved from baseline at all follow-up visits, indicating an improvement in skin hydration and skin barrier function, respectively. Image analysis for brightness (L*) showed statistically significant improvements from baseline at all follow up visits (all p?0.025; paired t-test). LYT2 was well tolerated with tolerability scores remaining similar to baseline scores, and highly rated by subjects for self-perceived efficacy and product attributes with a significant proportion of subjects agreeing to favorable responses by Week 12. Ninety-seven percent of subjects were satisfied with LYT2 by Week 12. Seventy-seven percent of subjects saw moderate or marked improvement by Week 12. Eighty-three percent of subjects agreed it performed better than past facial treatments.

Conclusion: Results from this study support the efficacy and tolerability of this HQ-free and retinol-free serum in improving the appearance of mild-to-severe facial melasma in subjects with self-perceived pregnancy-induced melasma.

Funding/Disclosures: This study was sponsored by Allergan. All authors met the ICMJE authorship criteria. All authors are employees of Allergan.

Understanding the African American facial aesthetic patient

Understanding the African American facial aesthetic patient

Presenters: Boyd C1, Alexis A2, Callender V3, Downie J4, Shumate GT5, Gallagher CJ5

Affiliations: 1BOYD, Birmingham, MI; 2Icahn School of Medicine at Mount Sinai, New York, NY; 3Callender Dermatology and Cosmetic Center, Glenn Dale, MD; 4Image Dermatology, Montclair, NJ; 5Allergan plc, Irvine, CA

Background/Objective: Aesthetic injectors might perceive challenges when addressing the aesthetic needs of African American patients. Understanding the anatomical considerations, facial aging patterns, aesthetic concerns, and treatment preferences might increase the comfort level for the injector and improve outcomes for African American patients. Injectors should also consider any patient misconceptions (e.g., keloid scarring) associated with injection procedures. Accordingly, clinical case studies can provide practical examples of how to implement this knowledge during patient consultation, assessment, and treatment. Two studies were performed to gain insights into self-reported facial aging characteristics and treatment considerations among African American patients.

Methods: Eight-hundred and fifty-nine African American men (145) and women (714) completed an online evaluation in which they assessed their facial features against photonumeric scales depicting degrees of severity for 10 facial characteristics. Four-hundred and one African American women completed a separate online evaluation to identify areas of aesthetic concern, relative prioritization of treatment areas, and attitudes toward injectable treatments. Respondents for both evaluations were naïve to facial aesthetic treatments. A subsequent meeting of experts with significant experience in treating African American patients produced case studies to illustrate the translation of these data to the clinical setting.

Results: In the African American population, moderate-to-severe signs of facial aging were not generally reported until 50 to 79 years of age. At ages 70 to 79 years, over 70 percent were still without moderate-to-severe perioral lines, loss of lip fullness, or midface volume loss. The majority reported having uneven skin tone/color (57%) and dark circles under the eyes (48%). African American patients were most bothered by their tear trough and submental regions. Areas most likely to be prioritized for treatment included tear trough, submental region, and horizontal forehead lines. In contrast, African American patients were less likely to prioritize treatment of perioral lines, lips, temples, and cheeks. African American women reported the lowest consideration rate for injectables (64%), compared to Asian or Hispanic individuals. “Looking good for their age” was the top reason for considering aesthetic treatment, but the cost, perceived safety, and side effects were the largest barriers. Clinical case studies demonstrated practical treatment strategies utilizing commercially available facial aesthetic products.

Conclusion: Across the two research studies, self-reported facial aging characteristics correlated with bothersome areas; both tear trough treatment and submental fat reduction could be seen as entry points for facial aesthetic injectables for this population. An understanding of these objective research findings and practical case studies might increase the comfort level for an injector and improve outcomes for African American patients.

Efficacy, safety, and patient-reported outcomes following onabotulinumtoxinA treatment for moderate-to-severe forehead lines: a pooled analysis of two Phase III pivotal trials

Presenters: De Boulle K1, Fagien S2, Mao C3, Shumate GT3, Gallagher CJ3

Affiliations: 1Aalst Dermatology Clinic, Aalst, Belgium; 2Aesthetic Eyelid Plastic Surgery, Boca Raton, FL; 3Allergan plc, Irvine, CA

Background/Objective: Two pivotal, Phase III studies were conducted to evaluate the safety and efficacy of onabotulinumtoxinA (onabotA) versus placebo (PBO) for treatment of moderate-to-severe forehead lines (FHL).

Methods: In both studies, neurotoxin-naïve subjects were randomized to receive onabotA 40U (frontalis 20U, glabella 20U) or PBO. The second study included an additional treatment arm in which bilateral crow’s feet regions (CFL) were also treated for a total dose of 64U (FHL 20U, GL 20U, CFL 24U) or PBO. After Day 180, all eligible subjects could receive up to two additional open-label onabotA treatments, with assessments to Day 360. Dynamic and static FHL were assessed at all timepoints by both investigator and subject using the Facial Wrinkle Scale with photo numeric guide. Subject satisfaction with treatment was evaluated using the validated Facial Lines Satisfaction Questionnaire (FLSQ).

Results: This pooled analysis comprised 1,178 subjects in the intent-to-treat (ITT) population (onabotA 40U n=608, onabotA 64U n=313; PBO n=257). At maximum eyebrow elevation, Day 30 responder rates for those achieving more than a 2-grade composite FHL improvement based on investigator and subject FWS were 53.1 (40U) and 53.0 (64U) percent, respectively. Responder rates for those achieving more than a 1-grade FHL improvement were 97.9 (40U) and 99.0 (64U) percent, respectively. Percentage of subjects achieving a score of none/mild FHL were 92.3 (40U) and 94.9 (64U) percent, respectively. Of those subjects with at least mild static FHL at baseline, 85.4 (40U) and 84.8 (64U) percent achieved more than a 1-grade improvement at rest. Efficacy and patient satisfaction were comparable across treatment cycles. Based on the FLSQ, 85.6 (40U) and 87.9 (64U) percent of subjects reported being mostly satisfied or very satisfied with the effect treatment had on their forehead lines at Day 60. Across all treatment cycles over 12 months, 25.4 percent of subjects had treatment-related adverse events; of note were brow ptosis (2.6%) and lid ptosis (1.8%). Most frequently reported treatment-emergent adverse events included headache (11.8%), injection site bruising (7.4%), nasopharyngitis (8.3%), and upper respiratory tract infection (4.3%). No new safety signals were detected with repeated upper facial line treatments.

Conclusion: OnabotA significantly improved the appearance of FHL. Treatment of upper facial lines was well tolerated with efficacy and patient satisfaction maintained across repeat treatments.

Reduction of submental fat continues beyond 28 days after ATX-101 treatment: results from a post-hoc analysis

Reduction of submental fat continues beyond 28 days after ATX-101 treatment: results from a post-hoc analysis

Presenters: Dover JS1, Shridharani SM2, Bloom JD3, Somogyi C4, Gallagher CJ4

Affiliations: 1SkinCare Physicians, Chestnut Hill, MA; 2LUXURGERY, New York, NY; 3Main Line Center for Laser Surgery, Ardmore, PA; 4Allergan plc, Irvine, CA

Background/Objective: ATX-101 (deoxycholic acid injection) is approved in the United States, Australia, Canada, and Europe for reduction of submental fat (SMF). When injected into subcutaneous fat, ATX-101 results in adipocytolysis, which induces a localized inflammatory response to clear cellular debris and lipids liberated from the injection site. In ATX-101 clinical trials, subjects received 4 to 6 treatments spaced at intervals of 28 ± 5 days. A post-hoc analysis was conducted to characterize the response after a single ATX-101 treatment using data from a patient experience management study (NCT02007434).

Methods: Adults aged 18 to 65 years with a moderate or large amount of SMF (as assessed via the validated 5-point Clinician-Reported and Patient-Reported SMF Rating Scales) who were dissatisfied with the appearance of their face or chin were enrolled. Subjects were randomized to one treatment with either ATX-101 (area-adjusted dose: 2mg/cm2) or placebo. This post-hoc analysis evaluated efficacy among ATX-101-treated subjects (n=68); subjects with moderate SMF at baseline based on clinician assessment (n=49) received 6mL of ATX-101 while subjects with severe SMF (n=19) received 8mL. Outcomes, evaluated at Days 28 and 84 following ATX-101 treatment, included the percentage of subjects who achieved at least a 1-grade improvement in SMF from baseline based on clinician assessment (CR-1 response), percentage of subjects who achieved at least 1-grade improvement in SMF from baseline based on clinician and subject assessment (composite CR-1/PR-1 response), and mean change in SMF thickness from baseline (measured with calipers).

Results: Most ATX-101-treated subjects were female (62%) and Caucasian (79%). At baseline, 72 percent versus 28 percent of subjects had a moderate versus large amount of SMF, respectively. At Day 28, the CR-1 response rate was 14.1 percent. By Day 84, the CR-1 response rate increased to 47.0 percent. Similarly, the composite CR-1/PR-1 response rate was 7.8 percent at Day 28, and increased to 37.9 percent by Day 84. SMF thickness increased from baseline by 2.1mm at Day 28, which might be related to residual swelling and/or induration within the treatment area. However, SMF thickness decreased from baseline by 1.3mm at Day 84.

Conclusion: Results from this analysis demonstrate that reduction of SMF continues in 2 to 3 months following ATX-101 treatment. Overall, these data provide evidence of a progressive reduction in SMF beyond the 28-day retreatment interval used in the pivotal clinical trials and suggest that benefit might be gained by extending the interval between ATX-101 treatments beyond 28 days.

Funding: Funded by Allergan plc.

Subject satisfaction demonstrated for two on-label injection volumes of abobotulinumtoxinA (ABO) when used to treat moderate-to-severe glabellar lines

Subject satisfaction demonstrated for two on-label injection volumes of abobotulinumtoxinA (ABO) when used to treat moderate-to-severe glabellar lines

Presenters: Cohen J1, Kaufman J2, Peredo M3, Jonas B4, Nogueira A4, Mashburn J4

Affiliations: 1Director of AboutSkin Dermatology and DermSurgery, Greenwood Village and Lone Tree, CO, Associate Clinical Professor, Department of Dermatology, University of Colorado, CO, and Assistant Clinical Professor, Department of Dermatology, University of California Irvine; 2Skin Associates of South Florida, Skin Research Institute, Coral Gables, FL; 3Marina I. Peredo, MD, Smithtown, NY; 4Galderma Laboratories, L.P., Fort Worth, TX

Background/Objective: In the United States (US), glabellar lines (GLs) are most often treated with botulinumtoxin type A (BoNT-A), and satisfaction with treatment is typically measured using patient-reported outcomes. Dysport (abobotulinumtoxinA [ABO]) is approved in the United States for the treatment of GLs and can be injected at two different injection volumes­—0.05mL and 0.08mL. This was a multicenter, randomized, subject- and evaluator-blinded study to evaluate the safety, efficacy, and subject satisfaction of two on-label injection volumes, 0.05mL/injection (Group A) and 0.08mL/injection (Group B), for the treatment of GLs. This report focuses on the subject satisfaction health-related quality of life aspects of the study.

Methods: Subjects with moderate-to-severe GLs at maximum frown were treated with ABO. Subjects were randomized to receive either 0.05mL/injection (Group A) or 0.08mL/injection (Group B), per the approved US label (5 injection points in the glabella area totaling 50U [10U at each injection site] for 1 treatment session). Subjects were given one treatment, then followed for up to four months. Subject assessments were completed before and after treatment.

Results: At 30 days posttreatment, the majority of subjects reported they were satisfied with how attractive they looked (86.7% for Group A, 76.7% for Group B), compared to baseline pretreatment, 20.0 and 36.7 percent, respectively. Subjects also felt more confident after either treatment (90.0% and 80.0% at Day 30, Group A and B, respectively) compared to baseline, 33.3 and 33.3 percent, respectively. At Day 30, subjects also reported an increase in psychological well-being (mean change from baseline 29.5 [P<0.0001] for Group A and 25.0 [P<0.0001] for Group B), being less bothered by their GLs (mean change from baseline 52.2 [P<0.0001] for Group A and 45.7 [P<.0001] for Group B), and looking four years younger than their current age compared to baseline (mean change from baseline -4.4 [P<0.0001] for Group A and -4.3 [P<0.0001] for Group B). These results were mostly maintained through 120 days posttreatment. There were no significant differences between treatment groups.

Conclusion: Subjects treated with two on-label injection volumes of ABO for moderate-to-severe GLs reported high subject satisfaction and increased psychological well-being through Day 120.

Funding: Galderma Laboratories, L.P.

Differential facial aesthetic treatment considerations for skin of color populations: African American, Asian and Hispanic

Differential facial aesthetic treatment considerations for skin of color populations: African American, Asian and Hispanic

Presenters: Boyd C1, Chiu A2, Montes JR3, Narurkar V4; Shumate GT5, Gallagher CJ5

Affiliations: 1BOYD, Birmingham, MI; 2The Derm Institute, Hermosa Beach, CA; 3José Raúl Montes Eyes & Facial Rejuvenation, San Juan, PR; 4Bay Area Laser Institute, San Francisco, CA; 5Allergan plc, Irvine, CA

Background/Objective: By 2050, more than half of the total population in the United States will be of African American, Asian, or Hispanic descent. The unique anatomical needs, aesthetic goals, and cultural considerations for these growing patient populations should be evaluated to optimize treatment expectations and outcomes. A research study was performed to gain insights into the areas of aesthetic concern, relative prioritization of treatment areas, and any barriers to receiving injectables among these populations.

Methods: Four-hundred and one African American, 403 Asian, and 401 Hispanic women living in the United States, aged 30 to 65 years, completed an online evaluation in which questions focused on identifying bothersome facial areas, consideration levels for facial aesthetic treatments, and any barriers to receiving injectables. A maximum difference scaling method was used to identify which of the 15 facial areas would be prioritized for treatment. Respondents were naïve to facial aesthetic treatments but were aesthetically oriented and were considering physician administered aesthetic treatment within the next two years.

Results: The Hispanic population reported the highest consideration rate for injectables (85%), followed by Asian (75%) and African Americans (64%). African American and Hispanics were most bothered by their submental region, whereas Asian respondents were most bothered by the area underneath the eyes (infraorbital area). All skin of color populations prioritized first the periorbital region (infraorbital and crow’s feet areas) followed by the submental area and forehead lines. Relative to the other populations, African American respondents expressed the highest prioritization of the submental region. All respondents then prioritized treatment of glabellar lines, nasolabial folds, and oral commissures. Analysis by increasing Fitzpatrick Type (I–VI) showed an increasing prioritization of the periorbital region and decreasing prioritization of the chin and perioral lines. Most frequently cited barriers to considering injectable treatment included safety and side effects, concern about injecting a foreign substance into the body, and cost.

Conclusion: Understanding the unique aesthetic considerations of a diversifying patient population is imperative. Differences in injectable consideration rates and bothersome areas were apparent across the patient populations evaluated, but there was consensus regarding the facial areas most likely to be prioritized for treatment. An understanding of the differential aging patterns, cultural considerations, and aesthetic goals for each patient population may help optimize treatment expectations and outcomes.

IncobotulinumtoxinA versus onabotulinumtoxinA in the treatment of glabellar facial lines: results from a multicenter, randomized, double-blinded trial

IncobotulinumtoxinA versus onabotulinumtoxinA in the treatment of glabellar facial lines: results from a multicenter, randomized, double-blinded trial

Presenters: Kane MAC1, Gold MH2, Coleman WP III3, Jones DH4, Tanghetti EA5, Alster TS6, Rohrer TE7, Burgess CM8, Shamban AT9

Affiliations: 1Manhattan Eye, Ear & Throat Hospital, New York, NY; 2Tennessee Clinical Research Center, Nashville, TN; 3Tulane Health Sciences Center, New Orleans, LA; 4Skin Care and Laser Physicians of Beverly Hills, Los Angeles, CA; 5Center for Dermatology and Laser Surgery, Sacramento, CA; 6Washington Institute of Dermatologic Laser Surgery, Georgetown University Hospital, Washington, DC; 7Skin Care Physicians, Chestnut Hill, MA; 8Center for Dermatology and Dermatologic Surgery, Washington, DC; 9University of California Los Angeles, Los Angeles, CA

Background/Objective: Botulinum toxin type A is a well-established treatment for glabellar frown lines. Head-to-head comparison studies have demonstrated that incobotulinumtoxinA (Xeomin®) versus onabotulinumtoxinA (Botox®) result in comparable safety and efficacy for both cosmetic and therapeutic uses. In 2011, incobotulinumtoxinA was approved by the United States Food and Drug Administration (FDA) for improvement in the appearance of moderate-to-severe glabellar frown lines with a recommended dosage of 20 units (U).

This is the first large, multicenter, randomized, double-blinded, parallel-group study to compare the efficacy and safety of incobotulinumtoxinA versus onabotulinumtoxinA after a single 20U treatment to improve the appearance of glabellar frown lines.

Primary endpoint was response defined as a 1-point or greater improvement from baseline on the Facial Wrinkle Scale (FWS) at maximum frown one month from treatment.

Methods: Patients were randomized 1:1. Two-hundred and fifty female subjects 18 to 50 years of age (median age was 41 for both groups) with moderate-to-severe GFL on a 4-point FWS at maximum frown were included. Study duration was 120 days for each subject, plus the individual duration of screening (Day ?14 to 0). Eligible subjects received a single injection of the study treatment at Day 0 (baseline). Dose was 20U in both treatment groups; injection volume was 0.5mL.

Results: Primary endpoint was met. Primary efficacy analysis demonstrated equivalence of incobotulinumtoxinA and onabotulinumtoxinA at one month, with 95.7 percent of subjects in the incobotulinumtoxinA group achieving at least a 1-point improvement on FWS and 99.2 percent of subject in that onabotulinumtoxinA group achieving the same. Treatment satisfaction for both groups remained above 90 percent for the entire four-month treatment period. Fourteen (11.5%) subjects treated with incobotulinumtoxinA reported treatment-emergent adverse events (TEAE); 18 (14.1%) of subjects in the onabotulinumtoxinA group reported TEAEs. The most common TEAE among both groups was headache (incobotulinumtoxinA: n=7; onabotulinumtoxinA: n=5).

Conclusion: IncobotulinumtoxinA and onabotulinumtoxinA result in similar efficacy and safety profiles for the treatment of glabellar facial lines.

Funding: This study was funded by Merz North America, Inc.

Microfocused ultrasound in combination with diluted calcium hydroxylapatite for improving skin laxity and the appearance of lines in the neck and décolletage

Presenter: Casabona G

Affiliation: Cosmetic and Surgical Dermatology and Mohs Surgery, Clinica Vida, Sao Paulo, Brazil

Background/Objective: Skin laxity and wrinkling on the neck and décolletage can be age-revealing. The objective of this study was to evaluate the combined use of microfocused ultrasound with visualization (MFU-V) and diluted calcium hydroxylapatite (CaHA) for treating lines and wrinkles of the neck and décolletage.

Methods: Subjects with moderate-to-severe lines on the neck and/or décolletage were retrospectively enrolled. Prior to MFU-V treatment, a topical anesthetic (7% lidocaine, 7% prilocaine) was applied. For both the neck and décolletage, subjects were treated at two depths using the 7MHz transducer at a focal depth of 3.0mm and the 10MHz transducer at a depth of 1.5mm, applying 150 lines for each transducer per site. Immediately after MFU-V, subjects received treatment with CaHA (1.5 ml diluted 1:1 with 1.5 ml of 2% lidocaine solution). For the neck, CaHA was injected subdermally in microdroplets using a fanning technique with a 25G long cannula from four points of entrance starting on top of the lines and extending in a fan shape around the lines to cover the same area as the MFU-V (half a syringe per side). A similar technique was used for décolletage, but with three points of entry. Injections were followed by vigorous massage to ensure that the product was evenly dispersed. Subjects were assessed for skin laxity and wrinkling in the neck and décolletage at baseline and at 90 days (2 blinded, independent evaluators) using three validated scales: Merz Aesthetics Décolleté Scale and Fabi-Bolton Chest Wrinkle Scale (both scales range from 0=no wrinkles, 1=mild wrinkles, 2=moderate wrinkles, 3=severe wrinkles 4=very severe wrinkles); and Allergan Transverse Neck Lines Scale (ranging from 1=no wrinkles to 5=very severe wrinkles. Subject satisfaction was assessed using a 5-point scale (1=very unsatisfied, 2=unsatisfied, 3=neither satisfied nor dissatisfied, 4=satisfied, 5=very satisfied). Pain was assessed and adverse events (AEs) were documented.

Results: At baseline, 24 out of the 42 subjects were given a Grade 2 in the Allergan Transverse Neck Line Scale by Evaluator 1; Evaluator 2 placed 23 out of 42 subjects in the Grade 2 category. None of the subjects achieved a Grade 1 for neck lines at baseline. At 90 days, Evaluators 1 and 2 placed 30 and 27 subjects, respectively, in the Grade 1 category for neck lines. At baseline, 17 out of 18 subjects and 16 out of 18 subjects were given a Grade 2 or higher on the Merz Aesthetics décolletage wrinkles scale. At 90 days, 18 out of 18 subjects achieved a Grade 2 or lower from both evaluators. Using the subject satisfaction scale at baseline, the majority (64.3%) were neither satisfied nor dissatisfied with the neck lines treatment. At Month 3, the majority (54.8%) were very satisfied with the neck lines treatment. At baseline, the majority (66.7%) were neither satisfied nor dissatisfied with the décolletage treatment. At Month 3, 50.0 percent were satisfied and 44.4 were very satisfied with the décolletage treatment. Mild pain was experienced by 90 percent of subjects during the procedure; 10 percent reported no discomfort at all. All subjects experienced bruising, which resolved in three to seven days. No other AEs were reported.

Conclusion: Combining MFU-V with 1:1 diluted CaHA is effective in improving the appearance of neck and décolletage lines and wrinkles. Both procedures were well tolerated, and subject satisfaction was high.