A Multicenter, Randomized, Evaluator-Blinded Study to Examine the Safety and Effectiveness of Hyaluronic Acid Filler in the Correction of Infraorbital Hollows.

BACKGROUND: Hyaluronic acid injections are increasingly used for correction of infraorbital hollows (IOHs). OBJECTIVES: Examination of effectiveness (IOH correction) and safety of Restylane® EyelightTM hyaluronic acid (HAEYE, Galderma, Uppsala, Sweden) injections. METHODS: Subjects with moderate/severe IOHs, assessed using the Galderma infraorbital hollows scale (GIHS), were randomized to HAEYE injections (via needle/cannula) (Day 1+optional Month-1 touch up) or no-treatment control. Primary endpoint was blinded evaluator-reported Month-3 response, defined as ≥1-point GIHS improvement from baseline (both sides, concurrently). Other endpoints examined investigator-reported aesthetic improvement (GAIS), subject-reported satisfaction (FACE-Q™ satisfaction with outcome; satisfaction questionnaire), and adverse events. RESULTS: Overall, 333 subjects were randomized. Month 3 GIHS responder rate was significantly higher with HA-EYE (87.4%) versus control (17.7%; p<0.001), and comparable between HA-EYE-needle and HA-EYE-cannula groups (p=0.967). HAEYE GAIS responder rate was 87.5-97.7% (Months 3-12). Mean FACE-Q Rasch-transformed scores were 64.3-73.5 (HAEYE) versus 14.1-16.2 (control) through Month 12. Subjects reported looking younger (≥71%) and less tired (≥79%) with reduced under-eye shadows (≥76%) and recovered within 3-5 hours, post-treatment. Efficacy was maintained through Month 12 (63.5% GIHS responders) and through Month 18, after Month-12 retreatment (80.3% GIHS responders; 99.4% GAIS responders; FACE-Q scores: 72.5-72.8). Forty subjects (12.7%) reported typically mild adverse events (4.9% HAEYE-needle; 20.9% HAEYE-cannula). CONCLUSION: HAEYE treatment was effective in correcting moderate/severe IOHs at the primary endpoint (Month 3). Efficacy was sustained through Month 12 after first treatment for 63.5% and through Month 18 for 80.3% (after one retreatment) with needle or cannula administration. Safety outcomes were reassuring.

PrabotulinumtoxinA for Treatment of Millennials With Moderate to Severe Glabellar Lines: Post Hoc Analyses of the Phase III Clinical Study Data.

BACKGROUND: The use of esthetic products by millennials is increasing, yet published clinical trial data in this population are limited. OBJECTIVE: To compare the efficacy and safety of prabotulinumtoxinA for the treatment of moderate to severe glabellar lines in millennial and nonmillennial patients. METHODS AND MATERIALS: Post hoc analyses were performed on the pooled population of all patients treated with 20U prabotulinumtoxinA in the 3 single-dose Phase III glabellar line clinical studies. Patients were grouped by age: millennials (born 1982-2000) versus nonmillennials (born ≤1981). One key efficacy end point was the proportion of responders with a ≥1-point improvement from baseline at maximum frown on the 4-point Glabellar Line Scale. Adverse events were also summarized. RESULTS: Responder rates among millennials (n = 65) were greater than those of nonmillennials (n = 668) by 7.7% on average across all visits; differences were statistically significant at Day 90. Responder rates at Day 90 were 90.2% and 76.1%, respectively (absolute difference of 14.0%, p = .01). Headache was the most common treatment-related adverse event, occurring in 9.0% and 9.4% of millennials and nonmillennials, respectively. CONCLUSION: A single dose of 20U prabotulinumtoxinA administered for the treatment of glabellar lines was similarly well-tolerated by both millennials and nonmillennials; overall, it was more efficacious in millennials.

The First of Two One-Year, Multicenter, Open-Label, Repeat-Dose, Phase II Safety Studies of PrabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients.

BACKGROUND: PrabotulinumtoxinA is a 900-kDa botulinum toxin type A produced by Clostridium botulinum. OBJECTIVES: The authors sought to investigate the safety of prabotulinumtoxinA for treatment of glabellar lines. METHODS: This was a multicenter, open-label, repeat-dose, 1-year phase II safety study. Adults with moderate to severe glabellar lines at maximum frown, as assessed by the investigator on the validated 4-point photonumeric Glabellar Line Scale (0 = no lines, 1 = mild, 2 = moderate, 3 = severe), were enrolled. On day 0, patients received an initial treatment of 20 U prabotulinumtoxinA (4 U/0.1 mL freeze-dried formulation injected into 5 target glabellar sites). On and after day 90, patients received a repeat treatment (RT) if their Glabellar Line Scale score was ≥2 at maximum frown by investigator assessment. Safety was evaluated throughout the study. RESULTS: The 352 study patients received a median total dose of 60 U, that is, 3 treatments per year. Fifty-one patients (14.5%) experienced adverse events (AEs) assessed as possibly study drug related; 11.1% experienced study drug-related AEs after the initial treatment. With each RT, progressively lower percentages of patients experienced study drug-related AEs. Six patients (1.7%) experienced study drug-related AEs of special interest: 3 eyelid ptosis (0.9%), 2 speech disorder (0.6%), and 1 blepharospasm (0.3%). Seven patients (2.0%) experienced serious AEs; none were study drug related. Of the 2393 samples tested, 2 patients (0.6%) tested positive for antibotulinum toxin antibodies at a single postbaseline visit. CONCLUSIONS: The safety of RTs of 20 U of prabotulinumtoxinA for moderate to severe glabellar lines was first established in this early phase II study based on a broad range of outcomes.

Retrospective review of delayed adverse events secondary to treatment with a smooth, cohesive 20-mg/mL hyaluronic acid filler in 4500 patients.

BACKGROUND: Recent publications have suggested an increased risk of delayed adverse events (DAEs) with a smooth, cohesive 20-mg/mL hyaluronic acid filler, Juvéderm Voluma (HA-V). OBJECTIVE: To examine the occurrence of HA-V DAEs and identify patterns and characteristics. METHODS: Charts from patients who received HA-V between February 1, 2009, and February 28, 2018 from 2 clinics were analyzed. RESULTS: In 4500 patients who received 9324 treatments with HA-V, 44 DAEs were identified, for a combined incidence of 0.98% per patient, 0.47% per treatment, and 0.23% per syringe. Patients with DAEs received a slightly larger cumulative amount of HA-V than those who did not. Delayed swelling and nodule formation were the most common reactions and occurred a median of 4 months after treatment, with an increase in frequency between October and January. About a third were preceded by an identifiable immunologic stimulus. DAEs were transient and resolved without incident. LIMITATIONS: The retrospective nature made it difficult to capture time to resolution or remember potential triggers. CONCLUSION: In this large, long-term, retrospective review, HA-V DAEs occurred at a rate of 0.98% per patient. Although the exact cause has yet to be elucidated, we hypothesize that an increase in fragmentation during the HA-V degradation process may trigger an inflammatory response after an immunologic trigger.

Microcannula Injection of Large Gel Particle Hyaluronic Acid for Cheek Augmentation and the Correction of Age-Related Midface Contour Deficiencies.

BACKGROUND: There is a growing trend toward the use of blunt-tip microcannulas for the treatment of midface volume loss with injectable hyaluronic acid. OBJECTIVE: To evaluate the safety and efficacy of large gel particle hyaluronic acid with lidocaine, injected with a blunt-tip microcannula, for cheek augmentation and the correction of age-related midface contour deficiency. MATERIALS AND METHODS: Sixty subjects with mild to substantial loss of midface fullness were treated to optimal correction. Adverse events (AEs) were obtained during each examination visit. Efficacy was evaluated using the Global Aesthetic Improvement Scale, the Medicis Midface Volume Scale (MMVS), and the FACE-Q subject satisfaction questionnaire through 16 weeks. RESULTS: Five AEs were reported, with only one being considered injection procedure-related (mild presyncope). No serious AEs were reported. Global aesthetic improvements were reported for the majority of subjects (≥98.3% for investigator-assessed and ≥91.5% for subject-assessed) for up to 16 weeks. At 8 weeks, the MMVS responder rate was 100% and subject satisfaction scores (5/6 questions) in the FACE-Q were ≥91.5%. CONCLUSION: Hyaluronic acid with lidocaine, injected with a blunt-tip microcannula, has a favorable safety profile and is effective up to 16 weeks for cheek augmentation and the correction of age-related midface contour deficiencies (NCT03160716).

Ten-Year and Beyond Follow-up After Treatment With Highly Purified Liquid-Injectable Silicone for HIV-Associated Facial Lipoatrophy: A Report of 164 Patients.

BACKGROUND: Highly purified liquid-injectable silicone (LIS) has been established as a permanent agent for off-label correction of HIV-associated facial lipoatrophy (HIV-FLA). However, controversy exists about long-term safety. OBJECTIVE: To establish the safety and efficacy at 10 years or greater of LIS for HIV-FLA. METHODS: Patients from 3 practices with 10-year or greater in-person office follow-up were analyzed to determine the number of LIS treatments and total volume required to achieve optimal correction. The nature of any treated adverse events was noted. RESULTS: One hundred sixty-four patients had 10-year or greater in-office follow-up. All subjects maintained long-term correction with an average of 9 treatments, average of 1.56 mL per treatment, and an average total of 14.1 mL. Two patients had severe adverse events manifesting as temporary facial edema. Four patients experienced mild-to-moderate excess fibroplasia presenting as perceived overcorrection, and 6 patients had nondisfiguring subcutaneous firmness. All adverse events were successfully treatable, mostly with intralesional 5-fluorouracil and triamcinolone. CONCLUSION: Liquid-injectable silicone is an effective long-term treatment option for HIV-FLA. When injected in small quantities with the microdroplet serial puncture technique at monthly or greater intervals, optimal correction appears durable for more than 10 years. Adverse events consisted mostly of excess fibroplasia and were treatable.

Evaluating the Efficacy of Different Platelet-Rich Plasma Regimens for Management of Androgenetic Alopecia: A Single-Center, Blinded, Randomized Clinical Trial.

BACKGROUND: Studies suggest platelet-rich plasma (PRP) may mitigate androgenetic alopecia (AGA), but each varies in the frequency of and interval between treatments. OBJECTIVE: To compare the efficacy, satisfaction, tolerability, and safety of 2 initial PRP injection protocols over 6 months. METHODS: Prospective, randomized, single-blinded trial among 40 patients with moderate AGA. Participants received subdermal PRP injections according to 1 of 2 treatment protocols: 3 monthly sessions with booster 3 months later (Group 1) or 2 sessions every 3 months (Group 2). Folliscope hair count and shaft caliber, global photography, and patient satisfaction questionnaires were obtained at baseline, 3 months, and 6 months. RESULTS: At 6 months, both groups demonstrated statistically significant increases in hair count (p < .001). These improvements occurred more rapidly and more profoundly for Group 1 (mean percent change: Group 1, 29.6 ± 13.6 vs Group 2, 7.2 ± 10.4; p < .001). Shaft caliber also increased significantly with no difference between groups. Treatments produced high satisfaction (82% "satisfied" or "highly satisfied") and were safe and well tolerated (mean pain score 2.1). CONCLUSION: Subdermal PRP injections are an efficacious and tolerable therapy among men and women with AGA. The benefits may be greater if first administered monthly. Clinicians should consider these findings when designing treatment plans.

Cohesive Polydensified Matrix Hyaluronic Acid for the Treatment of Etched-In Fine Facial Lines: A 6-Month, Open-Label Clinical Trial.

BACKGROUND: Available hyaluronic acid dermal fillers have unique biophysical properties that influence their clinical utility, longevity, and aesthetic outcomes. OBJECTIVE: To evaluate the effectiveness and durability of a cohesive polydensified matrix hyaluronic acid dermal filler (CPM-HA) for the treatment of etched-in fine facial lines. MATERIALS AND METHODS: Subjects with etched-in fine lines of the forehead, cutaneous lip, melolabial folds, nasolabial folds, and/or radial cheek received treatment with CPM-HA mixed with lidocaine and epinephrine, with an optional touch-up treatment at Week 2, if deemed necessary. Response to treatment (as measured by the Merz Aesthetics Scales, Lemperle Facial Wrinkle Scales, and subject self-assessment) and safety/tolerability were monitored over the course of 26 weeks. RESULTS: Thirty-one subjects received treatment with CPM-HA to 1 or more facial areas. All 5 treatment areas showed clinically meaningful and statistically significant improvements in average clinician rating scale scores at all study visits (p < .001 vs baseline). Most subjects reported maintained improvement from baseline of 50% or more throughout the 26-week study. Injection site reactions were mild and resolved without intervention. CONCLUSION: Cohesive polydensified matrix hyaluronic acid dermal filler treatment was well tolerated and provided consistent and durable improvement in the appearance of a diverse range of etched-in fine facial lines.

The Male Aesthetic Patient: Facial Anatomy, Concepts of Attractiveness, and Treatment Patterns.

BACKGROUND: The number of nonsurgical aesthetic procedures performed in men is growing rapidly. However, there are limited data on treatment principles and goals for the male aesthetic patient.

OBJECTIVE: To review the objective data available on male aging and aesthetics and to synthesize with expert opinion on treatment considerations specific to male patients.

METHODS: Expert advisors met to discuss anatomical differences in male versus female facial anatomy related to aging, facial treatment preferences in aesthetically oriented men, and current dosing data for facial injectable treatments in male versus female patients.

RESULTS: Symmetry, averageness, sexual dimorphism, and youthfulness are generally accepted as factors that contribute to the perception of attractiveness. There are differences between men and women in facial anatomy, concepts of attractiveness in the context of masculinity and femininity, and treatment objectives. A communication gap exists for men, as evidenced by the lack of information available online or by word of mouth about injectable treatments.

CONCLUSIONS: Approaches to aesthetic consultation and treatment should differ between men and women based on the fundamental dissimilarities between the sexes. Educating men about available aesthetic treatments and about the safety and side effects associated with each treatment, as well as addressing concerns about their treatment results looking natural, are key considerations.

J Drugs Dermatol. 2018;17(1):19-28.

Efficacy and Safety of ATX-101 by Treatment Session: Pooled Analysis of Data From the Phase 3 REFINE Trials.

BACKGROUND: ATX-101 (deoxycholic acid injection) is the only injectable drug approved for submental fat (SMF) reduction. In the phase 3 REFINE trials, adults with moderate or severe SMF who were dissatisfied with the appearance of their face/chin were eligible to receive up to 6 treatment sessions with ATX-101 (2 mg/cm2) or placebo. Primary and secondary endpoints, evaluated at 12 weeks after last treatment, significantly favored ATX-101 supporting its efficacy for reducing SMF and the psychological impact of SMF, and increasing satisfaction with the appearance of the face/chin. OBJECTIVES: To evaluate the efficacy and safety of ATX-101 by treatment session. METHODS: This post hoc analysis used pooled data from the REFINE trials to evaluate efficacy endpoints and adverse events following each treatment session to further characterize the ATX-101 treatment response and safety profile. RESULTS: In both treatment groups, mean injection volume declined over subsequent treatment sessions, though more markedly in the ATX-101 group. The majority of ATX-101-treated patients achieved a ≥1-grade improvement in SMF within 2 to 4 treatment sessions based on either clinician or patient assessment. Furthermore, 19.1% of ATX-101-treated patients (vs 3.9% of placebo-treated patients) received fewer than 6 treatment sessions owing to patient satisfaction with treatment or lack of sufficient SMF for further treatment. In both treatment groups, the incidence/severity of common injection-site adverse events declined over subsequent treatment sessions. CONCLUSIONS: Although up to 6 treatment sessions were permitted in the REFINE trials, most ATX-101-treated patients achieved an improvement in SMF within 2 to 4 treatment sessions. Level of Evidence: 3.

Efficacy of IncobotulinumtoxinA for the Treatment of Glabellar Frown Lines in Male Subjects: Post-Hoc Analyses From Randomized, Double-Blind Pivotal Studies.

BACKGROUND: Males are increasingly seeking minimally invasive cosmetic procedures such as botulinum toxin injection. However, few studies have specifically examined the efficacy of such procedures among men. OBJECTIVE: To assess the efficacy of incobotulinumtoxinA for treating glabellar frown lines (GFLs) in men. METHODS: Three incobotulinumtoxinA studies were included in post hoc analyses of responder rates: 2 pivotal Phase 3 US registration studies for GFLs (n = 55 males in a pooled analysis) and a European pivotal Phase 3 study for upper facial lines (UFLs; n = 21 males). RESULTS: In the pooled analysis of Phase 3 GFL studies, 55.9% of males and 81.4% of females were responders on the Facial Wrinkle Scale (FWS) at 30 days. Similarly, 54.5% and 88.0% of males and females, respectively, treated for GFLs in the upper facial line study were responders on the Merz Aesthetics Scales (MAS) at 30 days. Lower proportions of male responders on the Facial Wrinkle Scale /Merz Aesthetics Scales were consistent with results from onabotulinumtoxinA and abobotulinumtoxinA GFL studies. CONCLUSION: Compared with females, males demonstrate lower response rates on wrinkle severity scales in studies on all 3 available botulinum toxins. Variations in treatment response are potentially associated with key male anatomic differences (e.g., muscle mass). Results emphasize the need for customized treatment plans.

Tempering Patient Expectations and Working With Budgetary Constraints When It Comes to a Single Versus a Multimodal Approach.

BACKGROUND: This article is a review of the literature and the authors' experience in managing patients seeking facial and nonfacial rejuvenation procedures with budgetary constraints. OBJECTIVE: To provide readers with an approach to the cosmetic patient with financial limitations. METHODS AND MATERIALS: This article is written from a review of the literature and the authors' experience. RESULTS: The readers should learn how to better manage a patient with financial limitations seeking cosmetic procedures. CONCLUSION: Because patients seeking cosmetic procedures are often faced with budgetary constraints, it is important for the cosmetic physician to educate patients about available treatment options and their costs. Giving patients realistic expectations and tailoring treatment plans to the patient's primary goals and financial limitations can help maximize overall patient satisfaction.

Prevention and Management of Injection-Related Adverse Effects in Facial Aesthetics: Considerations for ATX-101 (Deoxycholic Acid Injection) Treatment.

ATX-101 (deoxycholic acid injection; Kythera Biopharmaceuticals, Inc. [an affiliate of Allergan plc, Dublin, Ireland]) was approved in 2015 in the United States (Kybella) and Canada (Belkyra) for submental fat reduction. As expected, injection-site reactions such as pain, swelling, and bruising, which were mostly mild or moderate and transient, were common adverse events (AEs) reported in clinical trials. An exploratory Phase 3b study investigating interventions for management of injection-site AEs associated with ATX-101 treatment was recently completed. Based on its results, literature review, and our clinical experiences, we have put forward considerations for management of AEs associated with ATX-101 treatment in clinical practice. Pretreatment with oral ibuprofen and/or acetaminophen an hour before treatment and preinjection with epinephrine-containing buffered lidocaine 15 minutes before treatment can help with management of pain and bruising. Cold application to the treated area before and immediately after the procedure may help to reduce pain (if local anesthetic preinjection is not performed) and swelling. Discontinuing medications/supplements that result in increased anticoagulant or antiplatelet activity 7 to 10 days before ATX-101 treatment, when possible, can reduce the risk of bruising. In summary, injection-site AEs associated with ATX-101 treatment can be effectively managed with commonly used interventions.

REFINE-1, a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial With ATX-101, an Injectable Drug for Submental Fat Reduction.

BACKGROUND: ATX-101, an injectable form of deoxycholic acid, is approved in the United States and Canada for submental fat (SMF) reduction. OBJECTIVE: To report results of REFINE-1, a randomized, double-blind, placebo-controlled, Phase 3 trial investigating the efficacy and safety of ATX-101. METHODS: Subjects dissatisfied with their moderate or severe SMF received ATX-101 (2 mg/cm) or placebo. Coprimary outcome measures were composite ≥1-grade and ≥2-grade improvements in clinician-assessed and subject-assessed SMF severity using validated scales at 12 weeks after last treatment. Magnetic resonance imaging (MRI) provided an objective measure of submental volume reduction. Patient-reported outcomes were assessed. RESULTS: Among 256 ATX-101-treated and 250 placebo-treated subjects, a ≥1-grade composite response was achieved in 70.0% and 18.6%, and a ≥2-grade composite response in 13.4% and 0%, respectively (p < .001 for both). The proportion of MRI responders was more than 8 times higher with ATX-101 than placebo (46.3% vs 5.3%; p < .001). ATX-101-treated subjects reported improvement in the psychological impact of SMF and satisfaction with treatment (p < .001 for all assessments vs placebo). Of note, 55% and 75% of ATX-101-treated subjects reported 1-grade improvement in clinician-assessed SMF after 2 and 4 treatments, respectively. Adverse events (primarily localized to the injection site) were mostly mild or moderate, and transient. Marginal mandibular nerve paresis reported in 4.3% of ATX-101-treated subjects (1.0% of all ATX-101 treatment sessions) was mostly mild, transient, and resolved without sequelae. CONCLUSION: ATX-101 is a safe and efficacious, first-in-class, injectable drug for SMF reduction.

Overview of ATX-101 (Deoxycholic Acid Injection): A Nonsurgical Approach for Reduction of Submental Fat.

In 2015, ATX-101 (deoxycholic acid injection; Kybella in the United States and Belkyra in Canada; Kythera Biopharmaceuticals, Inc., Westlake Village, CA [an affiliate of Allergan plc, Dublin, Ireland]) was approved as a first-in-class injectable drug for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat. ATX-101 has been evaluated in a clinical development program that included 18 Phase 1 to 3 studies supporting the current indication. Since 2007, the toxicity and safety profiles of ATX-101 have been characterized in numerous preclinical studies, its pharmacokinetics, pharmacodynamics, and optimal treatment paradigm have been defined in multiple Phase 1 and 2 studies, and its efficacy and clinical safety have been confirmed in 4 large Phase 3 trials (2 conducted in Europe and 2 in the United States and Canada [REFINE-1 and REFINE-2]). As subcutaneous injection of deoxycholic acid has been shown to cause adipocytolysis, the reduction in submental fat achieved after ATX-101 treatment is expected to be long lasting. This prediction is confirmed by data from long-term follow-up studies of up to 4 years after last treatment with ATX-101, which demonstrate that the treatment response is maintained over time in most subjects. ATX-101 offers a durable, minimally invasive alternative to liposuction and surgery for addressing submental fullness.

Proper Technique for Administration of ATX-101 (Deoxycholic Acid Injection): Insights From an Injection Practicum and Roundtable Discussion.

ATX-101 (deoxycholic acid injection; Kybella in the United States and Belkyra in Canada; Kythera Biopharmaceuticals, Inc., Westlake Village, CA [an affiliate of Allergan plc, Dublin, Ireland]) is the first aesthetic injectable approved for reduction of submental fat. In February 2014, an injection practicum was conducted in the anatomy laboratory at the University of Texas Southwestern Medical Center to explore the proper injection technique for ATX-101 and the importance of its appropriate, safe anatomical placement within the submental area. Subsequent to the injection practicum, a structured roundtable discussion was conducted in which potential implications of the various injection protocols evaluated during the practicum were reviewed. Furthermore, the faculty had the opportunity to provide additional perspectives based on their clinical experience with facial injectables and ATX-101 specifically. In this article, the findings from the injection practicum and roundtable discussion are reported.

Anatomy of the Cervicomental Region: Insights From an Anatomy Laboratory and Roundtable Discussion.

In 2015, ATX-101 (deoxycholic acid injection; Kybella in the United States and Belkyra in Canada; Kythera Biopharmaceuticals, Inc., Westlake Village, CA [an affiliate of Allergan plc, Dublin, Ireland]) was approved as a first-in-class injectable drug for reduction of submental fat. Use of a pharmacologic/injectable therapy within the submental region requires a thorough understanding of cervicomental anatomy to ensure proper injection technique and safe administration. To this end, an anatomy laboratory was conducted to review key external landmarks and important internal anatomic structures that characterize the lower face and anterior neck. External landmarks that define the boundaries of the cervicomental and submental regions were identified including the inferior mandibular border, the anterior border of the sternocleidomastoid muscle, the antegonial notch, the submental crease, the thyroid notch, and the hyoid bone. Relevant internal anatomic structures, including preplatysmal submental fat (the target tissue for ATX-101) and the platysma muscle as well as critical neurovascular and glandular tissues were revealed by dissection. Of particular interest was the marginal mandibular branch of the facial nerve because it typically courses along the inferior mandibular border near the proposed treatment area for ATX-101.

ASDS Cosmetic Dermatologic Surgery Fellowship Milestones.

BACKGROUND: The American Council of Graduate Medical Education, which oversees much of postgraduate medical education in the United States, has championed the concept of "milestones," standard levels of achievement keyed to particular time points, to assess trainee performance during residency. OBJECTIVE: To develop a milestones document for the American Society for Dermatologic Surgery (ASDS) Cosmetic Dermatologic Surgery (CDS) fellowship program. METHODS: An ad hoc milestone drafting committee was convened that included members of the ASDS Accreditation Work Group and program directors of ASDS-approved Cosmetic Dermatologic Surgery (CDC) fellowship training programs. Draft milestones were circulated through email in multiple rounds until consensus was achieved. RESULTS: Thirteen milestones were developed in the 6 Accreditation Council for Graduate Medical Education (ACGME) competency areas, with 8 of these being patient-care milestones. Additional instructions for milestone administration more specific to the CDS fellowship than general ACGME instructions were also approved. Implementation of semiannual milestones was scheduled for the fellowship class entering in July 2018. CONCLUSION: Milestones are now available for CDS fellowship directors to implement in combination with other tools for fellow evaluation.