BACKGROUND:Nasolabial folds (NLFs) are common age-related facial lines, often treated with dermal fillers. Princess FILLER Lidocaine (PFL; now saypha filler Lidocaine) and Juvéderm Ultra XC (JUXC) are both hyaluronic acid-based fillers used for this purpose. OBJECTIVES:The aim of the authors of this study is to evaluate the effectiveness and safety of PFL in reducing NLF severity compared with JUXC using a split-face study design. METHODS:In this randomized, subject- and investigator-blinded multicenter study, patients with moderate-to-severe NLFs received PFL on one side of the face and JUXC on the other. Baseline NLF severity was assessed using the 5-point NLF-Severity Rating Scale (NLF-SRS). Follow-up assessments occurred at Weeks 12, 24, 36, and/or 48. The primary endpoint was the proportion of NLF-SRS responders at Week 24. Secondary endpoints included assessments by photographic reviewers and treating investigators, along with Global Aesthetic Improvement Scale (GAIS) ratings. Safety was monitored by adverse event reporting and patient diaries. FACE-Q questionnaires evaluated patient satisfaction. Repeat treatment was permitted at Week 36 or 48 if needed. RESULTS:At Week 24, PFL demonstrated noninferiority to JUXC (82.2% vs 81.9% responders; difference 0.37%, P < .0001). Secondary assessments confirmed this finding. Adverse events occurred in 24.4% of patients post PFL, with most being mild to moderate. Serious treatment-emergent adverse events were rare (1.1%). CONCLUSIONS:PFL is a noninferior alternative to JUXC for treating moderate-to-severe NLFs, with comparable efficacy, safety, and patient satisfaction. LEVEL OF EVIDENCE: 1 (THERAPEUTIC):For image description, please refer to the figure legend and surrounding text.
BACKGROUND:Chemical peels are a safe and effective method to treat a wide range of both medical and cosmetic indications originating with acne scarring, pigmentary dyschromias, rhytides, and actinic keratoses. Over the past 2 decades, growing evidence has supported their continued use, while new techniques and innovative indications have broadened their applications in both medical and aesthetic dermatology. OBJECTIVE:To review the scientific and clinical advances of chemical peeling within dermatologic surgery. RESULTS:Since 2000, chemical peels have undergone significant advancements in formulation, in technique, and in application, offering a wider range of treatments for additional medical and cosmetic conditions. This progress is driven by enhanced research efforts spearheaded by the International Peeling Society(IPS-USA,) which has been dedicated to publishing these developments and actively promoting education with new techniques. CONCLUSION:Chemical peeling remains a cost-effective and easily accessible option in the 21st century for addressing a wide range of skin disorders across lighter and darker skin types.
*Volunteer Clinical Faculty, Department of Dermatology, UCSD, San Diego, California †Dermatology Institute, Chula Vista, California The author has indicated no significant interest with commercial supporters.
This chapter covers the full range of dermatologic surgery for residents in dermatology, family practice, and surgical specialties. Chemical peeling remains an important method to even out skin pigmentation and irregularities mostly related to chronic sun damage. Although the technique of chemical peeling is relatively simple, selection of patients and peeling agents is critical to achieve optimal results. Chemical peels can be used to treat a variety of skin disorders, including acne, dyschromias, photoaging, scarring, and epidermal growths. Peels are generally divided into three categories depending on depth of injury: superficial, medium-depth, and deep peels. Pre- and postpeel skin care regimens are vital for ideal outcomes. Low cost, ease of procedure, and longstanding safety and efficacy records make chemical peels useful tools in the dermatologic surgeon's armamentarium, despite the advent of modern lasers and radiofrequency devices.
BACKGROUND:Actinic keratoses (AKs) are a common premalignant cutaneous neoplasm and can progress to squamous cell carcinoma. A variety of treatment options are available for field therapy of diffuse AKs.OBJECTIVE:This review systematically analyzes the use of chemical peels for treatment of AKs.MATERIALS AND METHODS:A systematic review of PubMed was performed searching from 1946 to March 2020 to identify the literature on chemical peels for AKs.RESULTS:Of the 151 articles identified, 5 met inclusion criteria for review. Four of the reviewed articles demonstrated the efficacy of chemical peels in reducing AK count and minimal adverse effects. In some studies, chemical peels exhibited potential to prevent additional AK formation and development of keratinocyte carcinomas.CONCLUSION:Chemical peels are an efficacious and affordable treatment option for field treatment of AKs. With improved patient tolerance and adherence, chemical peels are an attractive option for field therapy of AKs for both dermatologists and patients.
BACKGROUND The aesthetic use of botulinum toxins is widely accepted in routine treatment of glabellar lines. OBJECTIVE To strengthen existing efficacy and safety data, and examine subject satisfaction concerning abobotulinumtoxinA (ABO) treatment for moderate to severe glabellar lines. MATERIALS AND METHODS A 150-day prospective, single-dose, multicenter, randomized, parallel-group, placebo-controlled, double-blind study of 300 subjects treated with ABO (50 Units [U]). Response was defined as having no or mild glabellar lines after treatment (primary objective was Day 30 response). Glabellar line severity, onset and duration of effect, satisfaction, treatment emergent adverse events (TEAEs), and treatment-related adverse events (TRAEs) were assessed. RESULTS Median time to onset of effect was 2 days. Day 30, ABO treatment response was 89% and 85% for investigator and subject assessments, respectively (p < .001 vs placebo). At Day 120, 60% of subjects demonstrated ≥1 grade improvement and 45% at Day 150. Subject satisfaction concerning glabellar line appearance was high (93%) at Day 14 and maintained by 35% through Day 150 with ABO treatment. No serious AEs were related to study treatment. CONCLUSION Most ABO-treated subjects sustained ≥1 grade glabellar line improvements over 120 days, and satisfaction was maintained by >30% of subjects throughout 150 days. ABO was well tolerated.
BACKGROUND A range of monophasic dermal fillers made of high-molecular-weight hyaluronic acid (HA) chains with reduced cross-linking was developed for aesthetic procedures. OBJECTIVE The efficacy, durability, and safety of 2 of these resilient HA (RHA) fillers, and their noninferiority to an effective HA comparator available in the United States, were tested in the treatment of dynamic facial wrinkles. METHODS A 15-month, prospective, multicenter, active-controlled, randomized, double-blinded, split-face clinical trial was carried out on 174 subjects presenting moderate-to-severe bilateral nasolabial folds (NLFs). Assessed parameters included improvement on a proprietary Wrinkle Severity Rating Scale (WSRS) and Global Aesthetic Improvement Scale, according to Blind Live Evaluators, subjects, and treating investigators. Self-perception was evaluated with FACE-Q and satisfaction scales. RESULTS The per-protocol populations included 67 and 62 subjects of all Fitzpatrick skin-phototypes, in the 2 comparison groups. Significant improvement of mean WSRS scores and associated responder rates established the noninferiority of RHA fillers to their comparator, over 15 months. Aesthetic improvement and subject satisfaction were durably high, with no meaningful differences between the fillers. Treatments were safe and well tolerated. CONCLUSION The 2 RHA fillers are at least equivalent to a well-established comparator for the correction of NLF in subjects of diverse skin-phototypes.
Introduction: Reconstitution of botulinum toxin type A formulations is typically required before injection. QM1114 is a novel ready-to-use liquid botulinum toxin type A formulation. The objective of this study was to evaluate efficacy and safety of 3 doses of QM1114 in esthetic treatment of glabellar lines (GLs).
BACKGROUND PrabotulinumtoxinA is a 900-kDa botulinum toxin Type A produced by Clostridium botulinum . OBJECTIVE To investigate the efficacy and safety of prabotulinumtoxinA for the treatment of glabellar lines. MATERIALS AND METHODS Adult subjects ( n = 330 in EV-001; n = 324 in EV-002) with moderate to severe glabellar lines at maximum frown on the 4-point Glabellar Line Scale (GLS; 0 = no lines, 1 = mild, 2 = moderate, and 3 = severe) were enrolled in 1 of 2 identical 150-day, double-blind, placebo-controlled, single-dose, Phase III studies. Subjects were randomized 3:1 to receive 20-U prabotulinumtoxinA or placebo. The primary efficacy end point was the proportion of responders on Day 30 where the investigator and subject independently agreed that a ≥2-point improvement had occurred on the GLS at maximum frown from Day 0. Adverse events (AEs) were evaluated throughout the study. RESULTS Responder rates in the prabotulinumtoxinA and placebo groups were 67.5% and 1.2% in EV-001 and 70.4% and 1.3% in EV-002; absolute differences between groups were 66.3% and 69.1% in EV-001 and EV-002, respectively (both p < .001). No serious AE in either study was assessed as study drug related. CONCLUSION In these studies, a single dose of 20-U prabotulinumtoxinA was safe and effective for the treatment of glabellar lines.
BACKGROUND:Microneedling and soft-tissue filler injections have been used independently to improve acne scarring. The effectiveness of a combined approach using microneedling followed by polymethylmethacrylate (PMMA)-collagen gel has not been carefully studied.OBJECTIVE:The goal of this study was to assess the effectiveness and safety of microneedling alone versus microneedling followed by injection of PMMA-collagen gel filler for correction of atrophic facial acne scars.METHODS:We conducted a multicenter, open-label, randomized, prospective study on subjects with distensible atrophic acne scars in the face to determine whether microneedling with PMMA-collagen gel is a superior acne scar treatment over microneedling alone. Forty-four subjects received 3 microneedling treatments over a 12-week period followed by randomization to treatments with PMMA-collagen gel (treatment group) or no further treatment (control group).RESULTS:At 24 weeks, the treatment group achieved a statistically significant improvement in acne scores over microneedling alone. The improvement continued at 36 weeks. At 24 weeks, the treatment group showed a strong trend in improvement on the Physician Global Aesthetic Improvement Scale compared with microneedling alone.
Background: DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A formulation in clinical development. A phase 2 dose-ranging study identified an optimal dose and demonstrated efficacy with a median duration of 24 weeks. Methods: In two phase 3, multicenter, randomized, double-blind, placebo-controlled studies (SAKURA 1 and SAKURA 2), subjects with moderate or severe glabellar lines at maximum frown were assigned randomly to receive placebo or 40 U of DAXI. Glabellar lines were evaluated at least every 4 weeks for at least 24 weeks until severity returned to baseline (≤36 weeks). Results: Overall, 609 subjects were enrolled (DAXI, n = 405; placebo, n = 204). DAXI was significantly more effective than placebo in achieving the primary efficacy outcome (≥2-point improvement in glabellar line severity at maximum frown at week 4 according to both investigator and subject ratings): 73.6 percent versus 0.0 percent (SAKURA 1), and 74.0 percent versus 1.0 percent (SAKURA 2) (both p < 0.0001). Composite investigator and subject ratings of maximum frown after DAXI treatment showed that glabellar line severity of none or mild was maintained for a median of 24.0 weeks (SAKURA 1) and 23.9 weeks (SAKURA 2), and glabellar line severity did not return to baseline levels for a median of 27.7 and 26.0 weeks, respectively. DAXI was generally well tolerated, with the most common adverse events related to DAXI treatment being headache (SAKURA 1, 7.0 percent; SAKURA 2, 5.9 percent) and injection-site pain (5.0 percent and 2.4 percent, respectively). Conclusions: Results from both studies were highly consistent. DAXI may offer a prolonged duration of response (median, ≥24 weeks) and is generally well tolerated. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.
BACKGROUND Skin cancers of the periorbital area present unique challenges to Mohs surgeons. OBJECTIVE The need for precise and high-quality Mohs micrographic surgery (MMS) is paramount because of the complex anatomy, vital structures, and potential threat to vision. METHODS A thorough comprehension of anatomy is essential to help predict tumor behavior and ensure successful outcomes for patients. RESULTS Tumors occurring at the medial and lateral canthi are of greatest concern for deeper orbital penetration. CONCLUSION In this study, we present our experience with MMS of periorbital tumors, including clinical pearls and techniques to aid the Mohs surgeon.
Mohs micrographic surgery is dependent upon accurate interpretation of frozen section slides to ensure complete tumor removal and high cure rates. The objective of this study was to determine an aggregate concordance of histologic frozen section interpretation between the Mohs surgeon and dermatopathologists as available in the literature. The study sought to assess the bias risk, applicability, and level of evidentiary support for studies of histologic accuracy between these two provider groups. A systematic literature review of three medical databases was conducted. The Quality Assessment of Diagnostic Accuracy Studies instrument was used to determine bias risk and applicability. The level of evidence was then determined by using the Center for Evidence-Based Medicine (CEBM) model. According to the literature, the concordance rate for frozen slide interpretation between fellowship-trained Mohs surgeons and dermatopathologists was 99.4% after reviewing 5,566 cases with CEBM Level 2 evidence. This study confirms a high level of correlation of histologic frozen section slide interpretation between fellowship-trained Mohs surgeons and dermatopathologists, which is supported by Level 2 evidence with low bias risk and low applicability concerns.
BACKGROUND:Juvéderm Vollure XC (VYC-17.5L; Allergan plc, Dublin, Ireland) belongs to a family of hyaluronic acid gels based on the Vycross technology platform.OBJECTIVES:The authors sought to evaluate the safety and effectiveness of Vollure for correction of moderate to severe nasolabial folds (NLFs) over 18 months and after repeat treatment.METHODS:In this prospective, randomized study, patients (N = 123) received initial/touch-up treatment with Vollure in 1 NLF and control filler in the contralateral NLF. Patients received optional repeat treatment with Vollure after month 12, 15, or 18. Assessments included investigator-rated NLF Severity Scale responder rates (≥1-point improvement vs baseline), patient-assessed Appraisal of Nasolabial Folds scale of the FACE-Q questionnaire, and patient satisfaction (11-point scale).RESULTS:Median volume of Vollure injected was 1.7 mL for initial/touch-up treatment combined and 0.6 mL for repeat treatment. The NLF Severity Scale responder rates were 93%, 85%, and 59% at months 6, 9, and 18 after initial/touch-up treatment and increased to 94% at 1 month after repeat treatment. Mean patient-reported FACE-Q scores significantly improved from baseline at all timepoints. Most patients were very satisfied with treatment at all timepoints from day 3 (75%) through month 18 (68%) and at 1 month after repeat treatment (94%). Common injection site responses after initial/touch-up and repeat treatment were firmness, swelling, and tenderness to touch; most were mild/moderate.CONCLUSIONS:Vollure was safe and effective for correction of moderate to severe NLFs, with results lasting 18 months in 59% of NLFs. Repeat treatment required one-third of the injection volume to achieve similar improvement in NLF severity as initial/touch-up treatment.LEVEL OF EVIDENCE: 2:
BACKGROUND Hyaluronic acid (HA) dermal fillers are frequently used to correct or smooth facial wrinkles and folds such as nasolabial folds. OBJECTIVE To compare the efficacy and safety of 2 HA gels, formulated by 2 different manufacturing processes: XpresHAn Technology (HA RRL [with lidocaine]) and Hylacross technology (HA JU —a comparator product without lidocaine). PATIENTS AND METHODS One hundred seventy subjects with bilateral nasolabial folds rated as moderate or severe, according to the Wrinkle Severity Rating Scale (WSRS), received injections of HA RRL in the nasolabial folds on one side of the face and HA JU on the other side. Investigator- and subject-assessed wrinkle severity was measured up to 48 weeks after final injection. RESULTS HA RRL exhibited a similar safety and efficacy profile compared with HA JU . Noninferiority of HA RRL was demonstrated at 24 weeks (WSRS mean change from baseline mean difference −0.1 [95% confidence interval: −0.15, 0.01], p = .090). Incidence of adverse events was 40% for both treatments. CONCLUSION HA RRL exhibited a similar safety and efficacy profile compared with HA JU .
Private PracticeTotal Skin and Beauty Dermatology Center, PCBirmingham, AlabamaDepartment of DermatologyUniversity of Alabama at Birmingham Birmingham, Alabama The authors have indicated no significant interest with commercial supporters.
BACKGROUND Mohs micrographic surgery enables the surgeon to maximize tumor removal while minimizing the amount of tissue being removed using advanced mapping techniques combined with microscopy. Interpretation of frozen section slides is vital to the success of Mohs micrographic surgery. OBJECTIVE Evaluate and confirm the congruence of frozen section slide interpretation between fellowship-trained Mohs surgeons and dermatopathologists. METHODS Retrospective cohort concordance study spanning 10 years (n = 1,720 cases). RESULTS The concordance rate for frozen slide interpretation between fellowship-trained Mohs surgeons and dermatopathologists in this study was 99.5%. CONCLUSION This study demonstrates agreement between the interpretation of histologic frozen section slides when evaluated by fellowship-trained Mohs surgeons and dermatopathologists.