A Review of Current Data on Duration of Effect in Glabellar Lines After Treatment With AbobotulinumtoxinA 50 U.

BACKGROUND: AbobotulinumtoxinA has become well established as a treatment option for moderate to severe glabellar lines since its first aesthetic approval in 2009. OBJECTIVE: Pivotal trials leading to regulatory approval showed that abobotulinumtoxinA treatment was associated with high responder rates when defined as achievement of none or mild glabellar lines (0 or 1 on the glabellar line severity scale) and a duration of action of up to 5 months. More recently, the goals for treatment of glabellar lines have shifted toward not only achieving a decrease in glabellar line severity but also ensuring that patients are satisfied with their experience. MATERIALS AND METHODS: Patients seek an improvement in the appearance of their glabellar lines while maintaining a "natural look," fast onset of effect, and long duration of response. RESULTS: Trial designs have evolved to meet these new targets, including expanding the definition of responders to those having at least 1-grade improvement in the glabellar line severity scale score from baseline coupled with the use of subject satisfaction and psychological well-being questionnaires. CONCLUSION: The findings demonstrate that abobotulinumtoxinA remains a well-tolerated and consistently effective treatment option associated with a rapid onset of effect, duration of efficacy lasting up to 6 months, and high, long-lasting levels of patient satisfaction.

The utility of artificial intelligence platforms for patient-generated questions in Mohs micrographic surgery: a multi-national, blinded expert panel evaluation.

BACKGROUND: Artificial intelligence (AI) and large language models (LLMs) transform how patients inform themselves. LLMs offer potential as educational tools, but their quality depends upon the information generated. Current literature examining AI as an informational tool in dermatology has been limited in evaluating AI's multifaceted roles and diversity of opinions. Here, we evaluate LLMs as a patient-educational tool for Mohs micrographic surgery (MMS) in and out of the clinic utilizing an international expert panel. METHODS: The most common patient MMS questions were extracted from Google and transposed into two LLMs and Google's search engine. 15 MMS surgeons evaluated the generated responses, examining their appropriateness as a patient-facing informational platform, sufficiency of response in a clinical environment, and accuracy of content generated. Validated scales were employed to assess the comprehensibility of each response. RESULTS: The majority of reviewers deemed all LLM responses appropriate. 75% of responses were rated as mostly accurate or higher. ChatGPT had the highest mean accuracy. The majority of the panel deemed 33% of responses sufficient for clinical practice. The mean comprehensibility scores for all platforms indicated a required 10th-grade reading level. CONCLUSIONS: LLM-generated responses were rated as appropriate patient informational sources and mostly accurate in their content. However, these platforms may not provide sufficient information to function in a clinical environment, and complex comprehensibility may represent a barrier to utilization. As the popularity of these platforms increases, it is important for dermatologists to be aware of these limitations.

Ultraviolet Protection From a Patented Amino Acid Complex Technology.

OBJECTIVE:   This study aimed to investigate the ultraviolet (UV) protection/repair benefits of a patented Amino Acid Complex (AAComplex). METHODS: I) AAComplex was incubated with dermal fibroblasts, with/without UVA, and collagen I was measured with a GlasBoxPlus device. II) A lotion, with/without AAComplex (1%) was applied topically to skin explants, following UVA irradiation, and quantified for health-related biomarkers (TNFalpha, histamine, and MMP-1). III) A broad spectrum sunscreen with SPF 46 and a skincare serum containing AAComplex (2%) were assessed using epidermal equivalents, in the presence of UV irradiation, for effects on IL-1alpha, thymine dimers, Ki-67, filaggrin and Nrf2. RESULTS: I) Collagen I synthesis in dermal fibroblasts was significantly decreased after UVA compared to without UV. The presence of AAComplex prevented this decrease. II) UVA irradiation of skin explants increased histamine, TNFα, and MMP-1. Hydrocortisone aceponate cream significantly decreases all 3 biomarkers. AAComplex contained lotion also significantly decreased all 3 biomarkers, the no AAComplex control lotion only reduced histamine. III) With the regimen of sunscreen + AAComplex contained skincare serum, the significant reduction in IL-1alpha was observed along with a complete recovery of Ki-67 and stimulation of filaggrin and Nrf2T. No thymine dimer positive cell was observed indicating the most positive skin impact from the regiment.  Conclusion: This research using different human skin models demonstrated that AAComplex can provide protection and damage repair caused by UV, at the ingredient level also when formulated in a serum or lotion formula. Skin may be best protected from UV damage when the regimen is used.   J Drugs Dermatol. 2024;23(5):366-375. doi:10.36849/JDD.7916.

Spontaneous resolution of eruptive papules following ablative laser resurfacing-Case report and review of laser-associated eruptive keratoacanthomas.

BACKGROUND: Keratoacanthomas (KAs) following laser treatment are a rare, but well-described entity. AIM: Herein, we describe a case of eruptive keratoacanthoma (KA) following laser resurfacing treatment and aim to better characterize laser-associated KAs. METHODS: A literature search was performed on PubMed reviewing laser-associated KAs including various characteristics: epidemiology, history of skin cancer, location, and number, type of laser, as well as the management and outcome. RESULTS: Fractional ablative was the most common type of laser triggering KAs, and most cases presented within the first month following treatment. The majority of cases of laser-induced KA had a prior history of a malignant or premalignant skin neoplasm. Laser-induced KAs were treated using modalities similar to KAs arising in other contexts. CONCLUSION: Clinicians need to be knowledgeable and prepared to understand, and manage complications following laser treatments, as rare as they may be, including KAs.

LetibotulinumtoxinA Attenuates the Psychological Burden of Glabellar Lines and Is Associated With High Subject Satisfaction in Phase 3 Clinical Trials.

BACKGROUND: Hyperfunctional glabellar frown lines can transmit facial miscues that adversely affect emotional communication, increase perceptions of age, and diminish self-esteem. OBJECTIVE: To evaluate the efficacy of letibotulinumtoxinA in mitigating the negative psychological impact associated with moderate to severe glabellar lines and to assess subject satisfaction with treatment outcome in the BLESS phase 3 clinical trials. MATERIALS AND METHODS: Baseline and posttreatment assessments were made using validated subject-administered instruments: Modified Skindex-16 Glabellar Line Quality of Life (GL-QoL) Scale, Facial Assessment and Cosmetic Evaluation Questionnaire (FACE-Q) Appraisal of Lines Between Eyebrows Scale, FACE-Q Age Appraisal Visual Analog Scale, and FACE-Q Satisfaction with Outcome Scale. An integrated analysis using pooled BLESS data was conducted on these secondary end points. RESULTS: Among enrolled and treated subjects ( N = 1,272), 85.5% had moderate to severe psychological impact at baseline. LetibotulinumtoxinA subjects experienced significant improvements compared with placebo on all measures. Mean improvement to Week 4 for the Modified Skindex-16 GL-QoL Scale overall score was -33.84 for letibotulinumtoxinA subjects compared with -1.37 for placebo subjects ( p < .001). Attenuation of psychological burden was highly correlated with improvement in glabellar line severity ( p < .0001). CONCLUSION: LetibotulinumtoxinA significantly improved the psychosocial burden associated with glabellar lines across all trials. Treated subjects experienced improved quality of life, younger perceived age, and satisfaction with treatment outcome.

A Novel Approach to Shaping the Lateral Abdomen: Simultaneous Application of High-Intensity Focused Electromagnetic (HIFEM) Therapy and Synchronized Radiofrequency at the Flanks: A Multicenter MRI Study.

BACKGROUND: An accumulation of adipose tissue on the lateral abdomen (flanks) coupled with muscle deconditioning negatively affects core stability, muscular balance, and the intrinsic strength essential for maintaining optimal body mechanics and posture. This lateral fat accumulation and diminution of muscle result in an unfavorable abdominal profile and present challenges in finding appropriately fitting attire. OBJECTIVES: The aim of this study was to explore the effectiveness and safety of the simultaneous application of high-intensity focused electromagnetic (HIFEM) therapy and synchronized radiofrequency for sculpting the lateral abdomen. METHODS: All patients were scheduled to undergo four 30-minute treatments at approximately weekly intervals and then subsequent follow-up visits at 1 month and 3 months after the last treatment. The primary evaluation assessed changes in the oblique muscles, adipose tissue thickness, and cross-sectional area (CSA) by MRI performed at baseline and follow-ups. The secondary outcomes included digital photographs of the treated areas, a Subject Satisfaction Questionnaire, and a Therapy Comfort Questionnaire. Adverse events and side effects were monitored throughout the study duration. RESULTS: The muscle tissue showed a substantial increase in thickness (+27.2%) and CSA (+29.0%). The adipose tissue measurements showed a decrease of -30.5% in CSA and -28.8% in thickness. As secondary outcomes, 81.8% of patients reported feeling more toned, and 84.9% of patients found the treatment comfortable and reported less than mild pain. CONCLUSIONS: Based on the evaluation, the study suggests that the simultaneous application of HIFEM and synchronized radiofrequency is safe and effective for reducing adipose tissue and strengthening muscle in the area of the lateral abdomen.

A focused review on laser- and energy-assisted drug delivery for nail disorders.

The purpose of this review is to consolidate and summarize laser-assisted drug delivery (LADD) for nail diseases, particularly onychomycosis and psoriasis. A PubMed search was conducted in June 2023 using search terms (1) "laser assisted drug delivery" AND "nail," (2) "laser" AND "nail," and (3) "nail disorder" AND "laser treatment." References of papers were also reviewed, yielding 15 papers for this review. Fractional ablative CO2 laser (FACL) and Er:YAG laser can be used for LADD of topical medications such as amorolfine, terbinafine, and tioconazole to treat onychomycosis. A fungal culture should be performed to determine the type of dermatophyte, which will help determine which topical will be most effective. Laser settings varied between studies, but overall LADD tended to be more effective than topical treatments alone. Laser-assisted photodynamic therapy (PDT) was also found to be effective in treating onychomycosis. For psoriatic nails, LADD was used to deliver calcipotriol-betamethasone dipropionate foam, tazarotene, triamcinolone, or methotrexate into the nail. Again, LADD was found to be significantly more effective than topical treatment alone. FACL was the only laser noted for use for LADD in both diseases. Laser-assisted drug delivery for nail disease is a newer approach for onychomycosis and nail psoriasis with several benefits and drawbacks. Dermatologists should discuss the option of LADD with their patients who have recalcitrant onychomycosis or nail psoriasis.

Efficacy and Safety of Tapencarium (RZL-012) in Submental Fat Reduction.

BACKGROUND: Tapencarium (RZL-012) (5-(3.6-dibromo-9H-carbazol-9-yl)-N, N, N-trimethylpentan-1-aminium chloride) is a novel injectable synthetic molecule with cytolytic properties, capable of reducing subcutaneous fat volume. OBJECTIVES: The goal of this 3-armed, randomized, double-blind, placebo-controlled phase 2b study was to determine the safety and efficacy of low- and high-dose RZL-012 vs placebo on submental fat (SMF) reduction. METHODS: Patients (n = 151, age 18-65 years) with excess SMF received a single treatment session of RZL-012 or placebo in the submental area, after which they were monitored for 84 days. SMF was assessed at baseline and after dosing with newly developed scales, namely the Clinician Chin Assessment Tool (C-CAT) and Subject Chin Assessment Tool (S-CAT). SMF was also assessed by magnetic resonance imaging (MRI) at screening and on Day 84 after treatment. RESULTS: The proportion of patients who had a 1-grade or 2-grade improvement in C-CAT and/or S-CAT on Day 84 vs baseline was significantly higher in the high-dose RZL-012 group vs the placebo group (P < .002). The relative percentage reduction in MRI-measured SMF volume (Day 84 vs screening) was significantly greater in the high-dose RZL-012 group vs the low-dose RZL-012 or the placebo group (P < .0001). Local injection site reactions were the most common adverse events (AEs). CONCLUSIONS: A single administration of RZL-012 into SMF resulted in significant improvement in submental appearance as assessed by clinicians, patients, and MRI. From a safety perspective, there were no serious AEs and no clinically significant changes in vital signs or laboratory tests over the course of the study.

Reduction of Erythema in Moderate-Severe Rosacea by a Low Molecular Weight Heparan Sulfate Analog (HSA).

Rosacea changes are a result of an immune mediated response and the angiogenic properties of the LL-37 peptide. This peptide induces an inflammatory signal that activates the NLRP3-mediated inflammasome, triggering rosacea pathogenesis. Research findings show that LL-37 peptide is inhibited by binding to a cell surface glycosaminoglycan, heparan sulfate. Heparan Sulfate Analog (HSA) is a proprietary low molecular weight analog of heparan sulfate that has been formulated into a Dermal Repair Cream (DRC), specifically to aid in such immune mediated responses. Herein, in vitro studies using human epidermal keratinocytes showed an increase in HSA decreased LL-37 toxicity and IL-8 cytokine release. A single-center, randomized double-blind trial included 16 subjects (Fitzpatrick skin types I-IV) with a clinical diagnosis of type 1 rosacea and moderate to severe facial erythema, who were undergoing Pulsed Dye Laser (PDL) treatment. The clinical improvements of their facial erythema were assessed at baseline, 2 weeks, 4 weeks, and 8 weeks. Results revealed that low molecular weight HSA significantly improves the clinical signs of rosacea during the 8 weeks of use likely resulting from inhibition of LL-37 induced IL-8 cytokine release. These findings support the use of DRC in rosacea topical treatment regimens as it demonstrates visible skin benefits and improves tolerability of PDL therapy in a shorter duration of time as compared with PDL alone.George R, Gallo RL, Cohen JL, et al. Reduction of erythema in moderate-severe rosacea by a low molecular weight Heparan Sulfate Analog (HSA). J Drugs Dermatol. 2023;22(6):546-553. doi:10.36849/JDD.7494.

Two-Step Skincare Regimen Addressing Aging in Three Unique Geographic Locations: A Prospective, Multi-Center, Open-Label Study.

BACKGROUND: Extrinsic factors including solar radiation and air pollution significantly impact facial skin aging. The efficacy and tolerability of a 2-step skincare regimen consisting of a vitamin C antioxidant serum (VCAS) and a 100% mineral tinted sunscreen moisturizer (TSM) were evaluated in women with hyperpigmented and photodamaged facial skin exposed to beach, mountain, and river-traversed basin city stressors. METHODS: This was an institutional review board (IRB)-approved, multi-center, prospective, open-label study involving healthy subjects. Thirty-six females aged 35 to 60 years with Fitzpatrick Skin Types I to V and exhibiting moderate to severe hyperpigmentation and moderate photodamage were recruited. The VCAS was applied to the global face twice-daily (morning and evening), and the TSM was applied in the morning with at least 2 reapplications during daily activity for 12 weeks. Clinical grading with a validated scale, standardized photography, and a self-assessment questionnaire were performed at baseline and weeks 4, 8, and 12. RESULTS: Statistically significant improvements were shown in clinically graded efficacy parameters at weeks 4, 8, and 12. Subjects showed an average improvement of 11.7%, 14.9%, and 19.1% in overall photodamage and an average improvement of 19.5%, 23.4%, and 24.5% in clarity/brightness at weeks 4, 8, and 12, respectively. Forehead lines and cheek lines demonstrated clinically significant improvement from baseline to week 12. Both products were well-tolerated and well-perceived by subjects. CONCLUSION: The 2-step skincare regimen was well-tolerated and effective in improving extrinsic signs of facial aging induced by solar radiation and air pollution stressors after 12 weeks of use. J Drugs Dermatol. 2023;22(1):16-22. doi:10.36849/JDD.7154.

Noninvasive Hands-free Bipolar Radiofrequency Facial Remodeling Device for the Improvement of Skin Appearance.

BACKGROUND: 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. OBJECTIVE: 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. PATIENTS AND METHODS: 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. RESULTS: 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. CONCLUSION: This study supports the use of this novel noninvasive hands-free bipolar facial remodeling device for the improvement of skin appearance.

Laser-Assisted Drug Delivery in the Treatment of Scars, Rhytids, and Melasma: A Comprehensive Review of the Literature.

Although broad reviews on laser-assisted drug delivery (LADD) have been published in the past, an updated focused examination of its utility in the context of common, treatment-resistant, dermatologic conditions has not been published. This article reports a comprehensive scoping review of the potential benefits of LADD compared to laser or drug monotherapy for the treatment of 3 such conditions: scars, rhytids, and melasma. A PubMed (National Institutes of Health; Bethesda, MD) search was conducted for keywords including "laser-assisted drug delivery," "scar," "rhytid," and "melasma." Out-of-scope studies were excluded. To evaluate the efficacy of LADD for the treatment of scars, relevant articles were categorized by scar type: hypertrophic/keloid, atrophic, and hypopigmented. LADD, with both ablative and nonablative laser types, was studied in combination with corticosteroids, botulinum toxin-A (BTX-A), 5-fluorouracil, 5-aminolevulinic acid photodynamic therapy, stem cells, platelet-rich plasma, and prostaglandin analogs for the treatment of scars. Some randomized controlled trials demonstrated the efficacy of LADD, whereas others showed no significant differences in clinical outcomes but demonstrated reduced adverse effects. Regarding rhytids, laser treatment has been combined with various cosmeceuticals, including poly-L-lactic acid, topical retinaldehyde, and topical BTX-A. The studies reviewed supported the use of LADD with these drugs over monotherapy. Some studies showed that LADD was effective for the absorption of drugs such as poly-L-lactic acid and BTX-A which are often not effective topically. For melasma treatment, LADD with tranexamic acid and hydroquinone was superior in some studies, but not significantly different than monotherapy in other studies. LADD with certain drugs could be considered to treat scars, rhytids, and melasma.

High Patient Satisfaction for up to 6 Months With OnabotulinumtoxinA Treatment for Upper Facial Lines.

BACKGROUND: OnabotulinumtoxinA safety and efficacy are well established for upper facial lines (UFL), including forehead lines (FHL), glabellar lines (GL), and crow's feet lines (CFL). OBJECTIVE: To investigate the association of onabotulinumtoxinA efficacy with patient-reported psychological impacts and satisfaction in UFL. MATERIALS AND METHODS: A pooled analysis of data from 4 pivotal Phase 3 trials (onabotulinumtoxinA vs placebo in FHL ± GL, FHL + GL ± CFL, CFL, and CFL + GL for ≤180 days) evaluated investigator-assessed ≥1-grade severity improvement on the Allergan Facial Wrinkle Scale at Day 30 (responders). Facial Line Outcomes (FLO-11) Questionnaire, Facial Line Satisfaction Questionnaire (FLSQ), and Subject Assessment of Satisfaction of Appearance (SASA) were used to evaluate responder appearance-related psychological impacts and satisfaction. RESULTS: OnabotulinumtoxinA patients, by primary study focus (FHL, GL, or CFL), totaled 921, 921, and 833, respectively; 786 patients received placebo. Most patients were female, White, and aged 45 to 50 years (median). Through 150 days, >42% FHL, >43% GL, and ≥32% CFL patients were onabotulinumtoxinA responders. Responders reported improvements in appearance-related psychological impacts (FLO-11) and high satisfaction (FLSQ and SASA), sustained through ≥150 days. CONCLUSION: A ≥1-grade improvement with onabotulinumtoxinA is a clinically meaningful outcome in UFL, associated with long-lasting improved patient-reported psychological impacts and high satisfaction.

An Open-Label Study Evaluating the Periorbital Skin Rejuvenation Efficacy of a Cosmeceutical Containing Methyl Estradiolpropanoate (MEP) in Women With Estrogen Deficient Skin (EDS).

BACKGROUND: A cosmeceutical topical formulation containing a non-hormonal estrogen receptor activator, Methyl Estradiolpropanoate (MEP), has been developed to address periorbital skin aging in post-menopausal women with estrogen-deficient skin (EDS). OBJECTIVE: The primary objective of the study was to evaluate the efficacy of Emepelle Eye Cream® (Biopelle, Ferndale Pharma Group, Ferndale, MI, USA) for the rejuvenation of the periorbital skin areas in women EDS. The secondary objectives were to assess the tolerability and satisfaction with Emepelle Eye Cream as assessed by the clinical investigator and the participants. METHODS: Clinical improvement (ie, change from baseline visit) to the end of study topical application in the periorbital areas were assessed by the clinical investigator using the clinician-rated quality of periorbital skin area visual scoring scale and by the participant using the participant’s self-evaluation of the quality of periorbital skin area questionnaire. Secondary objectives and endpoints were assessed using a subject Quality of Life (QoL) evaluation, a clinician- and a participant-evaluation of tolerability and side effects, and the C-GAIS and P-GAIS questionnaires. Baseline scores were compared to scores at the follow-up visits. RESULTS: Clinician evaluations included a Global Aesthetic Improvement Scale (GAIS) rating of periorbital skin areas using a 6-point rating scale as well as tolerability and side effects. The averaged clinical GAIS improvement for all subjects who completed the study improved by 21%. The mean clinician GAIS score at study completion was 2.7, and 26 of the 31 subjects who completed the study showed improvement. A clinician GAIS score of 1 (very much improved) was observed in 3 study subjects. The averaged subject improvement results included improvements in each category at the primary endpoint. The subjects reported that their satisfaction with their periorbital appearance improved by 47% as compared to before treatment. The product was well tolerated by all subjects and no significant side effects were reported. CONCLUSION: In an open label study of 31 female subjects who had been amenorrheic for at least one year, topical application of Emepelle Eye Cream for periorbital skin rejuvenation was effective and well-tolerated. J Drugs Dermatol. 2022;21(11):1185-1190. doi:10.36849/JDD.7279.