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DaxibotulinumtoxinA-lanm for injection (DAXI), a novel botulinum toxin type A formulation, contains a purified 150-kD core neurotoxin (daxibotulinumtoxinA) and proprietary stabilizing peptide (RTP004), and is approved for glabellar line treatment. As with any biologic product, DAXI may potentially be immunogenic and elicit unwanted antibody formation, possibly resulting in partial or complete treatment failure. The immunogenicity of DAXI was assessed in 2 double-blind, placebo-controlled, single-dose studies and an open-label safety study of up to 3 repeat treatments. Of the 2737 evaluable patients, none developed neutralizing antibodies to daxibotulinumtoxinA and 0.8% developed treatment-related nonneutralizing anti–daxibotulinumtoxinA-binding antibodies. Of evaluable patients exposed to RTP004 with either DAXI or placebo, 1.3% developed treatment-related anti–RTP004-binding antibodies, which were mostly transient. No patient developed binding antibodies to both daxibotulinumtoxinA and RTP004. All patients with treatment-related binding antibodies to daxibotulinumtoxinA or RTP004 achieved a clinical response (none or mild glabellar line severity) at Week 4 following each DAXI treatment cycle. The duration of clinical response was not different between treatment cycles when antibodies were detected vs when they were absent. Although the analysis population was small compared to the number of patients likely to receive repeated treatment in clinical practice, these results suggest that DAXI administration at the approved glabellar lines dose has low immunogenic potential and that nonneutralizing antibodies to daxibotulinumtoxinA or RTP004 occur infrequently and often transiently, and have no impact on clinical efficacy, safety, or duration of action. Real-world data encompassing larger numbers of patients is needed to substantiate these results. Level of Evidence: 3

Background Microneedling as an adjuvant to topical medications has shown promising but variable results in the treatment of melasma. Objective To conduct a systematic review and meta-analysis on the efficacy of microneedling as an adjuvant to topical therapies for the treatment of melasma. Methods This study followed PRISMA guidelines. All comparative, prospective studies on the use of topical interventions with microneedling for the treatment of melasma were included. Studies involving radiofrequency microneedling were excluded. Results Twelve eligible studies comprising 459 patients from 7 different countries were included. Topical therapies included topical tranexamic acid, vitamin C, platelet-rich plasma, non-hydroquinone-based depigmentation serums, and hydroquinone-based depigmenting agents. Topical therapy with microneedling improved melasma severity with a large effect (standardized mean difference >0.8) beyond 8 weeks, with best results seen at 12 weeks. Compared to topical therapy alone, topical therapy with microneedling resulted in an additional improvement in melasma severity with a moderate effect at 8 weeks and a large effect at 12-16 weeks. Microneedling was well tolerated across studies, with no serious adverse events reported. Limitations Heterogeneity in study designs did not allow for a comparison of the efficacy of various topical therapies with microneedling. Conclusion Microneedling is useful adjuvant to topical therapies for the treatment of melasma.

The Fraxel Dual laser system (Solta Medical, Inc., Bothell, WA) contains a 1,550 and 1,927 nm wavelength single handpiece with different indications for each wavelength.To discuss treatment setting recommendations and best practices for select on-label and investigational applications of the 1,550 and 1,927 nm dual laser system.Eight board-certified dermatologists with 10 or more years of experience with the 1,550 and 1,927 nm laser system completed an online survey about their clinical experience with the system and then participated in a roundtable to share clinical perspectives and best practices for using the laser system.For all Fitzpatrick skin types, treatment recommendations were described for selected approved indications for the 1,550 and 1,927 nm laser system, including both lasers in combination. Treatment recommendations were also reached for investigational applications with the 1,550 nm laser and 1,927 nm laser. Best practices for using the lasers during the treatment session to achieve optimal outcomes and decrease the post-treatment recovery time were compiled.The 1,550 and 1,927 nm dual laser system is effective for a wide range of aesthetic and therapeutic applications, on and off the face and across all Fitzpatrick skin types.

Background and objective Actinic keratoses (AKs) have been described with varying color and morphology; however, no reports have demonstrated associations between color, vasculature, and inflammation. In this retrospective study, we analyze the clinical, dermoscopic, and histopathologic features of AKs to elucidate this relationship. Methods A retrospective search for patients diagnosed with AK between January 2018 and October 2019 was performed. Clinical and dermoscopic photographs and pathology slides for all included subjects were reviewed. Results Forty-nine images and histopathology slides were analyzed. Dermoscopy of white AKs demonstrated scale and absence of erythema with corresponding absence of inflammation on histopathology. Dermoscopy of brown AKs revealed pseudonetwork, absent scale, and a variable vessel pattern with pigment incontinence and absence of inflammation on histopathology. Red AKs had a distinct polymorphous vessel pattern and presence of erythema on dermoscopy. On histopathology, about half of samples showed increased vascularity and variable inflammation. Pink AK dermoscopy revealed a presence of erythema with corresponding presence of inflammation on histopathology. Conclusion This report adds to our understanding of AKs and confirms that, in general, the pinker or redder the AK, the more prominent the inflammatory infiltrate and vasculature, respectively. Dermatologists should continue to use their diagnostic skills to successfully diagnose and triage AKs.

Simultaneous treatment of moderate-to-severe upper facial lines is reflective of real-world clinical practice.To evaluate the efficacy and safety of daxibotulinumtoxinA-lanm for injection (DAXI) for simultaneous treatment of glabellar, forehead, and lateral canthal (LC) lines.In this open-label, single-arm Phase 2 study, patients (48 enrolled, 94% completed, follow-up 24-36 weeks) received DAXI 40U (glabellar), 32U (forehead), and 48U (LC) lines. Key efficacy endpoints: percentages of patients achieving none/mild wrinkle severity (investigator-rated) for each upper facial line scale at Week 4.At Week 4, most patients achieved none/mild wrinkle severity (investigator-rated): glabellar (96%), forehead (96%), and LC (92%). Median times to loss of none/mild response (investigator- and patient-rated) among all patients were: 24.6 (glabellar), 20.9 (forehead), and 24.9 (LC) weeks; and 25.0, 24.0, and 28.1 weeks, respectively, among Week-4 responders. At Week 4, most patients reported improvements (Global Aesthetic Improvement Scale: 96%-98%) and high satisfaction rates (85%-98%). Five patients experienced treatment-related adverse events: injection-site erythema (3 patients/7 events), facial discomfort (2 patients/2 events), and headache (1 patient/1 event). No patients experienced eyebrow or eyelid ptosis.Simultaneous treatment of upper facial lines with DAXI was well tolerated and demonstrated high response rates, extended duration, and high patient satisfaction.https://clinicaltrials.gov/ct2/show/NCT04259086.

Aging is a multifactorial response to genetic preprogramming nuances, sun exposure, and ultraviolet radiation. Recently, there has been a paradigm shift toward minimally invasive rejuvenation.This prospective multicenter study aims to evaluate the efficacy and safety of a novel hands-free bipolar bulk radiofrequency (RF) device in terms of improvement in skin appearance.This multicenter prospective study enrolled subjects aged 35 to 75 years with visible signs of aging. The primary objective was to evaluate skin appearance pretreatment and at 1, 3, and 6 months after the final treatment. Each patient received 3 total treatments to the chin and cheeks using the hands-free RF device spaced 2 weeks apart.In total, data from 87 patients were assessed from 6 treatment sites. The average age was 54 years (range 35-75 years). Most patients were female (97%), and Fitzpatrick skin types I to V were represented. Overall, patients found the procedures to be relatively pain-free, and both patients and investigators felt they noted some improvement in their skin appearance. Histological sections demonstrated an increase in collagen or elastic fibers within the papillary dermis.This study supports the use of this novel noninvasive hands-free bipolar facial remodeling device for the improvement of skin appearance.

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 independently assessed by both investigator and patient 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 (IT) of 20 U prabotulinumtoxinA (4 U/0.1 mL final vacuum-dried formulation injected into 5 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 outcomes were evaluated throughout the study. Results The 570 study patients received a median total dose of 60 U, that is, 3 treatments. Sixty-one patients (10.7%) experienced adverse events (AEs) assessed as possibly study drug related; 6.5% experienced study drug–related AEs after the IT. With each RT, progressively lower percentages of patients experienced study drug–related AEs. Eight patients (1.4%) experienced study drug–related AEs of special interest: 5 experienced eyelid ptosis (0.9%), 3 eyebrow ptosis (0.5%), 1 blepharospasm (0.2%), and 1 blurred vision (0.2%). Seven patients (1.2%) experienced serious AEs, but none were study drug related. A total of 4060 serum samples were tested for antibotulinum toxin antibodies; no seroconversion was observed. Conclusions The safety of RTs of 20 U of prabotulinumtoxinA for moderate to severe glabellar lines was confirmed in this second phase II study based on a broad range of outcomes. Level of Evidence: 2

Background No validated assessment tools are available to evaluate patient-reported outcomes specifically related to submental fat (SMF). Objective To develop and validate scales measuring the severity (Patient-Reported SMF Rating Scale [PR-SMFRS]) and psychological impact (Patient-Reported SMF Impact Scale [PR-SMFIS]) of SMF. Materials and methods A literature review, content validation interviews (concept elicitation [n = 29] and cognitive debriefing [n = 15]) in adults with SMF, and expert interviews (n = 3) were conducted to develop the PR-SMFRS and PR-SMFIS. Psychometric validity (acceptability, reliability, and validity) for the PR-SMFRS and PR-SMFIS was assessed using data from 1 phase 2 and 5 phase 3 ATX-101 studies in patients with excess SMF. Results The PR-SMFRS was constructed as a single-item, 5-point rating of the SMF amount/size. The PR-SMFIS was constructed as a 6-item scale, with an 11-point numeric rating for each item. Both scales demonstrated acceptable psychometric properties (test-retest reliability and internal consistency). The anchor-based minimally important difference analysis suggests a 1-point improvement on the PR-SMFRS (scale of 0[FIGURE DASH]4) and a 3-point improvement on the PR-SMFIS (scale of 0[FIGURE DASH]10) represent clinically meaningful change. Conclusion The PR-SMFRS and PR-SMFIS are reliable, valid instruments for assessing the severity and psychosocial impact, respectively, of SMF and detecting clinically meaningful change with intervention.

Background and Objective Magnetic muscle stimulation (MMS) is a relatively new energy‐based technology that provides a non‐invasive option for body contouring through stimulation and toning of underlying skeletal muscles. This study was conducted to examine the safety, efficacy, and body satisfaction scores of MMS using a CoolToneTM prototype for the aesthetic improvement of abdominal and buttock contour. Study Design/Materials and Methods This was a prospective, non‐comparative, non‐randomized, 12‐week, multicenter study. Male and female participants aged 22‐65 years received 4 MMS treatment sessions to the abdomen and/or buttocks. Body Satisfaction Questionnaire (BSQ) scores for abdomen and/or buttocks were assessed at baseline, immediately post final treatment, at 4 weeks (primary endpoint), and 12 weeks post final treatment. Subject‐rated Global Aesthetic Improvement Scale (SGAIS) was assessed at 4 weeks post final treatment (secondary endpoint), and 12 weeks post final treatment. Additional efficacy assessment included abdominal circumference obtained by 3D imaging at baseline, immediately post final treatment, and at 4 and 12 weeks post final treatment. A Subject Experience Questionnaire (SEQ) was used to assess treatment satisfaction and perspectives at 4 weeks and 12 weeks post final treatment. Adverse events (AEs) were monitored throughout the study. Results A total of 110 participants were recruited, who were 75% female, 80% Caucasian (mostly non‐Hispanic), average age of 39.5 years (range 22–59) with an average body mass index (BMI) of 23.3 kg/m2 (range 18–29.9). At the 4‐week post final treatment visit, the average BSQ score for participants receiving abdominal treatment (n = 93) was significantly improved with a 5.1 average increase in total score from baseline (possible score range 10–50) and by a 5.5 average increase from baseline for participants receiving buttocks treatment (n = 32) (p “Improved” was 68.1% for participants receiving treatment of the abdomen (n = 94), and 81.8% for those receiving buttocks treatment (n = 33). The mean total decrease from baseline in waist circumference was significant at all time points. At the 12‐week post final treatment visit, SEQ data revealed that a majority of participants were “Satisfied” or “Very Satisfied” with overall treatment results and “Agreed” or “Strongly Agreed” that they were motivated to maintain results either by working out or by additional treatment. A total of 6 AEs related to the device and/or treatment were reported, which resolved spontaneously during the study. Conclusion Treatment of the abdomen and/or buttocks with MMS was well‐tolerated and demonstrated significant improvement in aesthetic appearance through the 12‐week post final treatment study duration. As a stand‐alone treatment, MMS expands the range of options for individualized treatment planning for patients seeking abdominal and/or gluteal muscle toning. © 2020 The Authors. Lasers in Surgery and Medicine published by Wiley Periodicals, Inc.

Lasers and energy-based devices (EBD) are popular treatments for skin rejuvenation and resurfacing. Achieving desired outcomes and avoiding complications require understanding the effects of these devices at a histologic level. Currently, no comprehensive review summarizing the histologic effects of laser and energy-based treatments exists.To describe how lasers and EBD alter skin histology and improve the overall understanding of these devices.A PubMed search was conducted for studies with histologic analysis of fractional picosecond laser, fractional radiofrequency microneedling, nonablative lasers, and ablative lasers.Fractional picosecond lasers induce intraepidermal and/or dermal vacuoles from laser-induced optical breakdown. Fractional radiofrequency microneedling delivers thermal energy to the dermis while sparing the epidermis, making it safer for patients with darker skin phototypes. Fractional nonablative lasers induce conical zones of coagulation of the epidermis and upper dermis. Ablative lasers vaporize the stratum corneum down to the dermis. Traditional ablative lasers cause diffuse vaporization while fractional ablative lasers generate columns of tissue ablation.Lasers and EBD are effective for skin resurfacing and rejuvenation and have different mechanisms with disparate targets in the skin. Safe and effective use of devices requires understanding the histologic laser-tissue interaction.

Background and objectives There is a wide diversity of opinions regarding the management of delayed inflammatory reactions (DIRs) secondary to hyaluronic acid (HA)-based fillers. The plethora of approaches has led the authors to conduct a review regarding management and treatment of DIRs as well as establish therapeutic guidelines for this purpose. Materials and methods A review of the literature was performed through databases such as PubMed using keywords including HA-fillers and complications, delayed HA filler sequelae and therapy, soft tissue and dermal filler reactions and management. Additionally, a survey comprised of questions regarding the management and treatment of DIRs was sent to 18 physicians highly experienced with soft-tissue filler injections in 10 countries. Their answers and recommendations were analyzed and debated amongst these panelists. Results Sixteen panelists favored antibiotic therapy as first -line treatment for DIRs, specifically dual antibiotic therapy consisting of a fluoroquinolone along with a tetracycline or macrolide for a period of 3-6 weeks. The majority refrained from the use of intralesional (IL) or systemic steroids except in the case of disfiguring or recalcitrant reactions. IL hyaluronidase was recommended by 13 panelists; however, some preferred a watchful waiting approach for a period of 48 hours to 2 weeks prior to IL hyaluronidase, and in cases where antibiotics did not lead to improvement. Conclusion A consensus was reached and summarized to propose a clear, easy-to-follow, stepwise algorithm for the treatment of DIRs.

Objectives To evaluate skin barrier and hydration effects of a new rebalancing moisture treatment (TRMT) and to assess efficacy and tolerability in subjects with photodamaged skin. Methods In an epidermal skin model, tissues (n = 5/group) were topically treated with 25 µL of TRMT, 25 µL of a market‐leading moisturizer (MLM), or untreated for 60 minutes. Hydration was measured at 0, 15, and 30 minutes. Tissues were harvested for gene expression analysis of markers associated with skin barrier and hydration: Claudin (CLD), Aquaporin (AQP), Hyaluronic Acid Syntheses (HAS), and Hyaluronidase (HYAL). A clinical study evaluated twice‐daily application of TRMT, assessing changes in fine lines/wrinkles, brightness, texture, erythema, and tolerability from baseline through week 8. Hydration was measured using electrical impedance. Results TRMT and MLM demonstrated significant increases in hydration vs untreated tissue at each timepoint (P

Background The number of patients receiving minimally and noninvasive cosmetic procedures is increasing. Often, patients turn to online review forums to gain and share advice regarding cosmetic procedures. Understanding and discussing patient-reported outcome data can help align physician and patient expectations and ultimately help improve the patient experience. Objective To determine the most common reasons patients are dissatisfied with a selection of minimally and noninvasive cosmetic procedures. Materials and methods Negative patient reviews from the RealSelf.com website were analyzed, and the reason for patient discontent was recorded for the following treatments: tissue stabilized-guided subscision, cryolipolysis, electromagnetic therapy, deoxycholic acid injections, energy-induced thermolysis, radio thermoplasty, threadlifts, and ultrasound therapy. Results One thousand two hundred four reviews were included in analysis. For all treatments analyzed, the most common reason for patient dissatisfaction was ineffectiveness (n = 782, 65.0%), followed by complications (n = 301, 25.0%). The most common complications were as follows: lumps for tissue stabilized-guided subscision (n = 6, 50.0%), treated area enlargement for cryolipolysis (n = 23, 22.1%), swelling for deoxycholic acid injections (n = 9, 47.4%), numbness for energy-induced thermolysis (n = 6, 35.3%), fat loss for radio thermoplasty (n = 26, 53.1%) and ultrasound therapy (n = 32, 48.5%), and indentations for threadlifts (n = 10, 30.3%). Conclusion Ineffectiveness and complications were the most common reasons for dissatisfaction among all treatments analyzed. Patient-reported outcome data may offer insight into how physicians can improve their patient's satisfaction with cosmetic procedures.

BACKGROUND ATX-101 (deoxycholic acid injection) is approved for reduction of moderate or severe submental fat (SMF). OBJECTIVE To evaluate the efficacy and safety of ATX-101 in subjects with mild or extreme SMF. PATIENTS AND METHODS Adults with mild or extreme SMF (based on clinician assessment) were randomized to receive ≤6 treatments with ATX-101 or placebo. Efficacy end points, evaluated at 12 weeks after last treatment, included percentage of subjects who achieved ≥1-grade improvement in SMF from baseline based on both clinician and patient assessment (composite CR-1/PR-1 response) as well as multiple subject-reported outcomes. Safety end points included change in skin laxity and incidence of adverse events. RESULTS Overall, 61.3% of ATX-101-treated subjects versus 6.7% of placebo-treated subjects with mild SMF and 89.3% versus 13.3% of subjects, respectively, with extreme SMF achieved a composite CR-1/PR-1 response (p < .001 for both). ATX-101-treated subjects also reported higher levels of satisfaction and greater reductions in the psychological impact of SMF versus placebo-treated subjects regardless of baseline SMF severity. Skin laxity was unchanged or improved in most of the subjects. Adverse events were mainly mild/moderate, transient, and associated with the injection site. CONCLUSION ATX-101 was efficacious and well tolerated for reduction of mild or extreme SMF.

Radiographic imaging has demonstrated muscle hypertrophy after treatment with noninvasive body contouring devices that target skeletal muscles.This pilot study sought to evaluate whether increased muscle mass translated to improved functional strength and endurance.A prospective, single-center, randomized open-label controlled study included 26 subjects randomized into 3 groups: 2 treatment groups and 1 control group. Both treatment groups received 4 neuromuscular electrical stimulation (NMES) treatments over a 2-week period. Muscle performance testing was conducted at baseline and 2-week and 4-week posttreatment. Anthropometric measurements were assessed at baseline and at 4-week posttreatment. Study participants completed subject satisfaction surveys and a personal experience assessment.Treatment with NMES resulted in statistically significant improvements in abdominal and quadriceps strength and endurance from baseline through 4-week posttreatment. Mean waist circumference decreased and quadriceps circumference increased, both nonsignificantly. Subject satisfaction regarding abdominal and quadriceps strength was reported as "satisfied or very satisfied" in 89% and 92% at 4-week and 8-week posttreatment, respectively.Treatment of the abdomen and quadriceps with NMES leads to significant improvements in muscular strength and endurance.

Background Fractional laser treatment was introduced in 2004 as a non-invasive technique to treat sun-damaged and aging skin. Since then, numerous ablative and non-ablative photothermolysis technologies and devices have been introduced, increasing the options for clinicians and patients but also increasing the complexity regarding which system to use and the techniques to optimize outcomes. No two devices are the same and the user-manuals preset dosimetry does not address many clinical situations, which can create confusion for new and inexperienced users. Methods An online survey addressing use of a 1550 nm /1927 nm dual wavelength, non-ablative, fractional laser was sent to eight (8) US board certified dermatologists with extensive experience in the use of the device. The survey included 39 questions, addressing experience, best practices and recommendations for use. Results The survey data suggests that the device can be used to treat patients of all ages and skin types for indications including photoaging and photodamage, periorbital wrinkles, freckles, (ephelides), solar lentigines, poikiloderma, scarring due to acne or surgery. It can be used on both facial and non-facial areas, including neck, chest, hands, arms, abdomen, legs, and buttocks. Unexpected and adverse effects were rarely reported and those that did were mild and transient. Conclusions This position paper provides practical real-world guidelines resulting from a small survey of experienced users, for new and early uses of the novel 1550 nm /1927 nm dual wavelength, non-ablative, fractional laser. J Drugs Dermatol. 2021;20(11):1150-1157. doi:10.36849/JDD.6181.

COVID‐19 continues to affect the delivery of healthcare services, as practices across North America gradually re‐open with new safety measures and practice guidelines. Specifically in dermatology, clinical care is delivered in close physician‐patient proximity through physical examination and the use of additional diagnostic and therapeutic procedures. We designed a 10‐question survey to better understand how COVID‐19 has impacted the delivery of care in North American dermatology practices. Survey questions explored themes including changes in patient volumes, the use of virtual visits/teledermatology, the frequency of aesthetic and surgical procedures, and other related topics. We invited 102 board‐certified dermatologists working in a variety of medical, aesthetic, surgical, and mixed practices, to participate in our survey hosted through Qualtrics XM. These dermatologists were selected based on their geographic location and our ability to access their contact information. Each dermatologist received an individualized e‐mail and survey link; however, all survey responses were anonymized. In 2.5 weeks after survey invitations were sent, the survey was viewed and completed by 71 and 54 dermatologists, respectively. The second wave of e‐mails was sent to the remaining 48 dermatologists who had not yet completed the survey, after which 15 participants both viewed and completed the survey. In total, 69 responses were recorded with an overall response rate of 67.6%. We report decreased patient volume capacity, fewer aesthetic and surgical procedures, and an increase in the use of virtual medicine among board‐certified North American dermatologists. However, this represents a reflection on perspectives at a single time point in a rapidly evolving situation. Understanding the full scope of the impact that COVID‐19 continues to have on dermatologic care is paramount to effectively serve our patients.

ImportanceLaser-assisted drug delivery (LADD) is used for various medical and cosmetic applications. However, there is insufficient evidence-based guidance to assist clinicians performing LADD.ObjectiveTo develop recommendations for the safe and effective use of LADD.Evidence ReviewA systematic literature review of Cochrane Central Register of Controlled Trials, Embase, and MEDLINE was conducted in December 2019 to identify publications reporting research on LADD. A multidisciplinary panel was convened to draft recommendations informed by the systematic review; they were refined through 2 rounds of Delphi survey, 2 consensus meetings, and iterative review by all panelists until unanimous consensus was achieved.FindingsOf the 48 published studies of ablative fractional LADD that met inclusion criteria, 4 were cosmetic studies; 21, oncologic; and 23, medical (not cosmetic/oncologic), and 6 publications of nonablative fractional LADD were included at the request of the expert panel, producing a total of 54 studies. Thirty-four studies (63.0%) were deemed to have low risk of bias, 17 studies (31.5%) had moderate risk, and 3 (5.5%) had serious risk. The key findings that informed the guidelines developed by the expert panel were as follows: LADD is safe in adults and adolescents (≥12 years) with all Fitzpatrick skin types and in patients with immunosuppression; it is an effective treatment for actinic keratosis, cutaneous squamous cell carcinoma in situ, actinic cheilitis, hypertrophic scars, and keloids; it is useful for epidermal and dermal analgesia; drug delivery may be increased through the application of heat, pressure, or occlusion, or by using an aqueous drug solution; laser settings should be selected to ensure that channel diameter is greater than the delivered molecule; antibiotic prophylaxis is not recommended, except with impaired wound healing; antiviral prophylaxis is recommended when treating the face and genitalia; and antifungal prophylaxis is not recommended. The guideline’s 15 recommendations address 5 areas of LADD use: (I) indications and contraindications; (II) parameters to report; (III) optimization of drug delivery; (IV) safety considerations; and (V) prophylaxis for bacterial, viral, and fungal infections.Conclusions and RelevanceThis systematic review and Delphi consensus approach culminated in an evidence-based clinical practice guideline for safe and effective use of LADD in a variety of applications. Future research will further improve our understanding of this novel treatment technique.