Stephanie Kao BA,a Alexi Kiss MD,b Tatiana Efimova PhD,b,c Adam J. Friedman MDc,d
Seborrheic keratosis (SK) is the most common skin tumor seen by dermatologists in everyday practice. Although the lesions are mostly benign, many patients still elect to have asymptomatic SK removed. The historical standards of treatment are cryosurgery and electrocautery, two surgical options that are effective at lesion removal but have high rates of postoperative adverse events such as treatment-site scarring and pigmentary alterations. The cosmetic outcomes of SK treatment modalities are of keen interest to dermatologists, as the American population becomes increasingly more diverse. In this article, the inclusion of darker Fitzpatrick skin types into clinical studies investigating post-treatment side effects of SK therapy is reviewed. The recent approval of a 40% hydrogen peroxide topical formulation is discussed in light of these issues, and several non-invasive topical treatments that optimize cosmetic outcomes of SK lesion removal are highlighted. Finally, treatment strategies aimed at reducing cost and minimizing the burden of adverse sequelae are provided.
J Drugs Dermatol. 2018;17(9):933-940.
Jose Raúl Montes MD FACS FACCS and Elizabeth Santos DrPH
Men’s interest and participation in cosmetic procedures has increased in recent years; however, the factors that motivate or discourage men from undergoing these procedures is not well understood. To evaluate which factors impact men’s decisions towards cosmetic procedures, an observational, single-site, cross-sectional study utilizing a voluntary questionnaire was executed in a target population size of 209 men ≥21 years old who visited the study site from 2015 to 2017. A majority of the male respondents incorporate a basic skincare regimen into their daily routine (90%), have had experience with neurotoxin treatments (54%), and expressed interest in either neurotoxin or dermal filler treatments (77% and 83%, respectively). The main motivating reason to undergo a cosmetic procedure was pursuit of a youthful appearance and the main discouraging reasons were cost and time for appointments or recovery. This study suggests that a majority of our male patients have either embraced or are interested in cosmetic treatments, but the cost and time play a big role in their decision. As cosmetic providers, we should reflect a commitment to the male population through marketing efforts and offerings to increase participation in minimally invasive aesthetic procedures.
J Drugs Dermatol. 2018;17(9):941-946.
Patrick Micheels MDa and Martinien Obamba Engb
Background: Adding lidocaine to hyaluronic acid (HA)-based gels appeared to modify their rheological properties, in the view of the first author.
Objective: This paper sought to compare the rheological properties of three CE-marked and FDA-approved gels, administered with and without lidocaine, along with two other newly FDA-approved gels.
Methods: The tested gels were as follows: NASHA® Restylane® with and without lidocaine; CPM®; Belotero® Balance with and without lidocaine; 3-D Matrix®; Surgiderm® 30XP (without lidocaine) and Juvederm® Ultra 3- Juvederm® Ultra Plus XC (with lidocaine); Preserved Network® RHA®2 (with lidocaine); Vycross® Volbella® (with lidocaine). For rheological analyses, viscoelastic data were collected with plate-plate geometry of 25mm, temperature regulated by a Peltier-effect plate, and the following assessed: Strain sweep from 0.01% to 3000% strain at 1Hz over frequency sweep from 0.1 to 100 Hz.
Results: NASHA Restylane gels with and without lidocaine exhibited similar viscoelastic characteristics, with very similar tan δ values, but the elastic modulus G’ proved significantly higher when the gel was injected with lidocaine vs without. 3D-Matrix Surgiderm 30XP gel without lidocaine and Juvéderm Ultra 3 with lidocaine exhibited similar viscoelastic characteristics, as well as tan δ values, yet the elastic modulus G’ of Surgiderm 30XP proved significantly higher than that of Juvederm Ultra 3-Juvederm Ultra Plus XC. CPM Belotero Balance gels with and without lidocaine exhibited similar G’ and G’’ values. tan δ was somewhat higher when the gel was administered without lidocaine. VYCROSS Volbella gel exhibited a higher elastic modulus G’ than the other Allergan gels, roughly nearing the NASHA gel values. Preserved Network RHA 2 gel exhibited values that were close to its partially cohesive "competitors", except for Vycross.
Conclusion: Adding lidocaine to HA gels does modify their rheological properties yet this, to a variable extent depending on the
J Drugs Dermatol. 2018;17(9):948-954.
Akash Dhawan,a Sunil Dhawan MD,b,c Domenico Vitarella PhDd
Botulinum toxins have been utilized in a number of cosmetic and therapeutic applications. One of the more novel uses of botulinum toxin involves its use to mitigate the effects of superficial cutaneous scarring. This is accomplished by decreasing the dynamic tension of a wound by denervating the underlying muscle. Studies have indicated that botulinum toxin serotypes A and B have a positive effect on wound healing and scar appearance. However, larger prospective, blinded, randomized, placebo-controlled clinical trials are required to refine this concept and target optimum toxin dose placement, timing, and concentration. The delayed onset of effect of available botulinum toxins is likely not taking full advantage of the scar improvement capabilities of the toxin, considering the time to immobilization of the muscle is a key factor in the improvement of wound healing with this technique. Furthermore, it has been noted in studies that the use of botulinum toxin can result in significant, yet temporary functional issues, due to prolonged paralysis of the muscle. In this paper, we review the role of botulinum toxin in improving scar appearance, evaluate animal and human studies to date demonstrating its effect on scarring, and highlight an opportunity for continued research in this application.
J Drugs Dermatol. 2018;17(9):956-958.
Jeremy A. Brauer MD,a,b Mitalee P. Christman MD,b Yoon Soo C. Bae MD,a,b Leonard J. Bernstein MD,a,c Robert Anolik MD,a,b Ron Shelton MD,a,d Roy G. Geronemus MDa,b
Introduction: This was a prospective non-randomized observational study of female subjects seeking treatment for cellulite who were consecutively enrolled into a registry. The objective was to evaluate the efficacy and safety of a tissue stabilized-guided subcision device for the treatment of cellulite using three-dimensional (3D) imaging analysis.
Methods: Subjects received a single treatment to the buttocks and/or posterolateral thighs with the study device. Follow-up telephone evaluations were conducted at 3 and 14 days to evaluate safety and 30 and 90 days to evaluate efficacy. Subjects returned to clinic at three months to obtain follow-up two dimensional and 3D imaging.
Results: Sixteen women of average age 44.1 years with a total of 291 lesions of cellulite were treated. Thirteen subjects presented for all follow up visits. Physicians graded results an average of 2.23/5 or “much improved” to “improved” with 9 subjects as much or very much improved (69.2%). Blinded assessors graded overall improvement an average of 2.8 (26-75% improvement) with 8 subjects having greater than 50% improvement overall (61.6%). Improvement in dimple depth was graded an average of 2.9, with 9 subjects having greater than 50% improvement (69.2%). Analysis of 3D imaging yielded 67.4% average improvement in negative volume and 58.4% improvement in minimum height of dimples. Most expected treatment effects resolved within three months after treatment.
Conclusion: Utilizing three-dimensional imaging analysis, investigators quantitatively and objectively demonstrated efficacy of a tissue stabilized-guided subcision device in the treatment of cellulite of the buttocks and thighs.
J Drugs Dermatol. 2018;17(9):960-965.
Doris Day MD,a Cheryl M. Burgess MD,b Leon H. Kircik MDc
Background: Melatonin is an endogenous hormone commonly associated with regulation of sleep. However, over the last two decades, research has elucidated a range of effects associated with the compound, including anti-inflammatory, both direct and indirect antioxidant activity, tissue regenerative benefits, and preservation of mitochondrial function. Melatonin’s anti-inflammatory and antioxidant support, coupled with its mitochondrial support, make it an intriguing target for use to support skin health. Human skin and hair follicles express functional melatonin receptors. They also engage in substantial melatonin synthesis. By supporting cutaneous homeostasis, melatonin and its metabolites are thought to attenuate carcinogenesis and possibly other pathological processes, including hyperproliferative/inflammatory conditions.
The primary extrinsic driver of aging has been considered to be exposure to ultraviolet (UV) light, which is well-established to contribute to sunburn, immunosuppression, skin aging, and carcinogenesis. Topically applied melatonin has been shown to reduce markers of reactive oxygen species formation and to reverse signs of skin aging.
As the global population continues to age, photo-damage remains a significant cutaneous concern. While use of sunscreens and UV avoidance strategies are essential to mitigate skin cancer risks, the potential to protect the skin and improve the appearance of photo-damage through the use of topical antioxidant support is appealing. The evidence suggests that melatonin deserves consideration for topical use as an anti-aging and skin protective agent. It is shown to be both safe and effective when topically applied.
J Drugs Dermatol. 2018;17(8):966-969.
Alexis Lyons MD,a Joseph Stoll BS,a and Ronald Moy MD FAADa
Introduction: Melasma is a condition in which patients develop symmetric, reticulated, hyperpigmented macules and patches on the face which is thought to be the result of ultraviolet (UV) exposure and hormonal influences, although the pathogenesis is not completely understood. The topical application of epidermal growth factor has been used as a whitening agent, moisturizer, and an aid for wound healing. In this study, we explore the efficacy of topical EGF in the treatment of melasma.
Materials and Methods: This was a randomized, double-blind, placebo-controlled, split-face study to determine the efficacy of a topical EGF serum in the treatment of melasma. Fifteen women with a mean age of 44 were randomized to treatment side of the face and applied a topical EGF serum and a placebo twice daily to each designated side of the face for eight weeks. Patient satisfaction was assessed by use of the MelasQoL Questionnaire as well as a patient outcome survey. Subjects were evaluated using the Physician Global Aesthetic Improvement Scale (GAIS) by two board-certified dermatologists.
Results: GAIS scores showed an improvement in the melasma in 73.4% of subjects vs 13% improvement for the placebo side. The average MelasQoL questionnaire score decreased from 42 to 33 with 73% of subjects having an improvement in their score. In addition, 73% of subjects reported an improvement in their melasma. No adverse events or side effects were reported with use of the topical serum or placebo.
Conclusions: This study suggests that topical EGF is a safe, noninvasive, and effective treatment for melasma.
J Drugs Dermatol. 2018;17(6):970-973.
Elizabeth T. Makino BS MBA,a Annie Jain MD,b Priscilla Tan BA,a Audrey Nguyen BS,a Alain Moga MSc,c Cécile Charmel,d Kuniko Kadoya PhD,a Tsing Cheng PhD,a and Rahul C. Mehta PhDa
Introduction: Air pollution continues to be a global health concern and recent studies have shown that air pollutants can cause skin damage and skin aging through several pathways that induce oxidative stress, inflammation, apoptosis, and skin barrier dysfunction. Preventive measures need to be considered to retain optimal skin health, and topical skincare products may be able to alleviate the negative effects of air pollution on skin. A randomized, double-blind, placebo-controlled clinical usage study was conducted to assess the efficacy and tolerability of a novel two-part skincare system (LVS) that was developed to provide protection against environmental skin aggressors including air pollution. After 8 weeks of use in subjects exposed to extremely high levels of pollution, LVS provided significant improvements compared to placebo in all clinical efficacy parameters including crow’s feet wrinkles, overall skin damage, skin tone evenness, tactile roughness, and visible redness. Subject self-assessment questionnaires showed that the treatment product was highly rated in self-perceived efficacy. Decreased SQOOH and MDA content in skin swab samples suggest that LVS helped to reduce oxidative stress in patients’ skin. Histological analyses of biopsy samples using biomarkers related to skin structure, damage and function (collagen IV, MMP1, CPD, and CD1a) further support the clinical benefits of LVS. Altogether, the presented study is among the first to show that topical skincare products can help to reduce pollution-induced skin damage and improve skin quality, especially when specifically formulated with active ingredients that combat the harmful effects of air pollutants.
J Drugs Dermatol. 2018;17(9):975-981.
Björn Lundgren PhD,a Ulrika Sandkvist MSc,a Nicole Bordier MSc,b Beatrice Gauthier DVMb
Background: The rheological properties of HA products have been investigated thoroughly, and these properties have been used to predict the clinical performance of HA fillers. It has been suggested that firm gels have a better ability to withstand deformation, and softer gels have been claimed to integrate and spread more into the tissue since they are perceived to deform more easily. However, the scientific published data regarding product integration of filler products with different physicochemical properties is limited. Thus, there is a need to improve the understanding regarding links between rheological properties of the gel material and the clinical performance.
Objective: The objectives of this study were: to develop and validate a photo scale for assessment of product distribution after intradermal injection, and to evaluate if product differences, such as overall rheological properties, gel particle size, swelling factor, and cohesivity effect the product distribution into the tissue after intradermal injections.
Material and Methods: Intradermal injections of HA fillers were performed in ex vivo human abdominal skin samples. The skin samples were processed for histological evaluation. In order to evaluate the product integration after intradermal injection and compare the results between different products a 5-grade product integration scale (from 0 to 4) was developed based on representative microphotographs. The scale was validated and used for the evaluation of integration of the different products used in the study. The results were correlated with the rheological properties of the different products.
Results: G’, the elastic modulus, is one important rheological parameter. Strong and firm gels have higher G’ than weak and soft gels. When plotting the G’ to mean product integration score in human skin obtained in the study, there was a statistically significant correlation with products with lowest G’ having the highest integration score and products with high G’ having the lowest integration scores. No statistical correlation could be seen when analyzing the score versus particle size, swelling factor, and cohesivity.
Conclusion: The degree of product integration can be assessed and scored according to a 5-grade visual scale based on representative microphotographs. Products with different rheological properties distribute differently when injected into the skin. Firmer gel texture resulted in more targeted product integration whiles softer gel texture resulted in distributed product integration.
J Drugs Dermatol. 2018;17(9):982-986.
Angela Moore MD,a Lawrence J. Green MD,b Suzanne Bruce MD,c Neil Sadick MD,d Eduardo Tschen MD MBA,e Philip Werschler MD FAAD FAACS,f Fran E. Cook-Bolden, MD,g Sunil S. Dhawan MD,h Douglass Forsha MD,i Michael H. Gold MD FAAD,j Scott Guenthner MD,k Steven E. Kempers MD,l Leon H. Kircik MD,m Jennifer L. Parish MD,n Marta I. Rendon MD,o Phoebe Rich MD,p Linda Stein-Gold MD,q Stephen K. Tyring MD PhD,r Robert A. Weiss MD FAAD,s Adnan Nasir MD,t Carsten Schmitz MD PhD,u* Terry I. Boodhoo MS,u Alexandre Kaoukhov MD,u,* and David R. Berk MDu
Background: Side effects may limit the use of current tetracycline-class antibiotics for acne.
Objective: Evaluate the efficacy and safety of once-daily sarecycline, a novel, narrow-spectrum tetracycline-class antibiotic, in moderate to severe acne.
Methods: Patients 9–45 years with moderate to severe facial acne (Investigator’s Global Assessment [IGA] score ≥ 3, 20–50 inflammatory and ≤ 100 noninflammatory lesions, and ≤ 2 nodules) were randomized 1:1 to sarecycline 1.5 mg/kg/day or placebo for 12 weeks in identically designed phase 3 studies (SC1401 and SC1402).
Results: In SC1401 (sarecycline n=483, placebo n=485) and SC1402 (sarecycline n=519, placebo n=515), at week 12, IGA success (≥ 2-grade improvement and score 0 [clear] or 1 [almost clear]) rates were 21.9% and 22.6% (sarecycline), respectively, versus 10.5% and 15.3% (placebo; P less than 0.0001 and P equals 0.0038). Onset of efficacy in inflammatory lesions occurred by the first visit (week 3), with mean percentage reduction in inflammatory lesions at week 12 in SC1401 and SC1402 of −51.8% and −49.9% (sarecycline), respectively, versus −35.1% and −35.4% (placebo; P less than 0.0001). Onset of efficacy for absolute reduction of noninflammatory lesion count occurred at week 6 in SC1401 (P less than 0.05) and week 9 in SC1402 (P less than 0.01). In SC1401, the most common TEAEs (in ≥ 2% of either sarecycline or placebo group) were nausea (4.6% [sarecycline]; 2.5% [placebo]), nasopharyngitis (3.1%; 1.7%), headache (2.7%; 2.7%), and vomiting
(2.1%; 1.4%) and, in SC1402, nasopharyngitis (2.5%; 2.9%) and headache (2.9%; 4.9%). Most were not considered treatment-related.
Vestibular (dizziness, tinnitus, vertigo) and phototoxic (sunburn, photosensitivity) TEAEs both occurred in ≤ 1% of sarecycline patients.
Gastrointestinal TEAE rates for sarecycline were low. Among females, vulvovaginal candidiasis (SC1401: 1.1% [sarecycline] and 0 [placebo];
SC1402: 0.3% and 0) and mycotic infection (0.7% and 0; 1.0% and 0) rates were low.
Conclusion: The narrow-spectrum antibiotic sarecycline was safe, well tolerated, and effective for moderate to severe acne, with low
rates of side effects common with tetracycline antibiotics.
J Drugs Dermatol. 2018;17(9):987-996.
Monica Boen MD, Marwan Alhaddad MD, Isabella Guiha BSc, Douglas P. Wu MD PhD, Mitchel P. Goldman MD
Introduction: Lip plumpers are topical agents that offer immediate, but temporary, volumization of the lips. While these products are becoming increasingly popular and are available at multiple retailers, there is a lack of clinical studies to evaluate the efficacy, longevity, and safety of the lip plumping products.
Methods: This is a prospective, single center, clinical trial to evaluate the duration, efficacy, and safety of a lip plumping agent in two clinical visits. Lip volume and adverse event were assessed by two clinicians at various time points: 15 minutes, 1 hour, 2 hours, 3 hours, and 4 hours.
Results: Twenty-two subjects were enrolled in the study, and eighteen completed the study. Investigator assessments of global improvement 15 minutes after application of the lip plumping product demonstrated improvement in lip fullness in 100% of the subjects (18/18), and 1 hour post-application 67% (12/18) showed an improvement in lip fullness that was statistically significant compared to the 2-hour assessment (P less than 0.05). Subject evaluations noted improvement in lip fullness 15 minutes post-application in 94.4% (17/18) of subjects, and 1 hour post-application, 89% (16/18) of the subjects who completed the trial noted some improvement in the volume of their lips that was statistically significant compared to the 2-hour post-application time point (P less than 0.0001). Subjects noted that they did experience a tingling and heat sensation, but a majority noted that that this sensation lasted less than 15 minutes.
Discussion: Our study demonstrated that the lip plumping product increased lip volume in almost all patients 15 minutes post-application and showed a continued improvement in lip fullness per investigator assessments 1 hour after application. Adverse events of a tingling or heat sensation were expected and observed as the topical product contained capsaicin, cinnamon, and menthol, all of which can induce this sensation by the release of substance P.
J Drugs Dermatol. 2018;17(9):999-1004.
Antonella Melina MSc,a Nhan Ngo Dinh MSc,b Benedetta Tafuri MSc,c Giusy Schipani MD,d Steven Nisticò MD,d Carlo Cosentino PhD,a Francesco Amato PhD,a Diane Thiboutot MD,e Andrea Cherubini PhDb
Introduction: The evaluation of Acne using ordinal scales reflects the clinical perception of severity but has shown low reproducibility both intra- and inter-rater. In this study, we investigated if Artificial Intelligence trained on images of Acne patients could perform acne grading with high accuracy and reliabilities superior to those of expert physicians.
Methods: 479 patients with acne grading ranging from clear to severe and sampled from three ethnic groups participated in this study. Multi-polarization images of facial skin of each patient were acquired from five different angles using the visible spectrum. An Artificial Intelligence was trained using the acquired images to output automatically a measure of Acne severity in the 0-4 numerical range of the Investigator Global Assessment (IGA).
Results: The Artificial Intelligence recognized the IGA of a patient with an accuracy of 0.854 and a correlation between manual and automatized evaluation of r=0.958 (P less than .001).
Discussion: This is the first work where an Artificial Intelligence was able to directly classify acne patients according to an IGA ordinal scale with high accuracy, no human intervention and no need to count lesions.
J Drugs Dermatol. 2018;17(9):1006-1009.