Franchesca D. Choi BS RPh,a,b Calvin T. Sung BS,a,c Margit L.W. Juhasz MD,a Natasha Atanaskova Mesinkovska MD PhDa
IMPORTANCE: The use of nutraceuticals such as collagen for skincare has been rising, but regulations are lacking on quality, absorption, and efficacy. To address this knowledge gap, clinical studies regarding the potential effects of collagen-based dietary supplements on skin are being completed.
OBJECTIVE: To review the literature and assess available randomized-controlled trials using collagen supplementation for treatment efficacy regarding skin quality, anti-aging benefits, and potential application in medical dermatology.
EVIDENCE REVIEW: A literature search was conducted with PubMed using search criteria (collagen) AND (supplement OR food OR nutrition). No lower limit on the year of publication was set. Inclusion criteria were: randomized, placebo-controlled trials using collagen supplementation in human subjects related to dermatology and written in English.
FINDINGS: Eleven studies with a total of 805 patients were included for review. Eight studies used collagen hydrolysate, 2.5g/d to 10g/d, for 8 to 24 weeks, for the treatment of pressure ulcers, xerosis, skin aging, and cellulite. Two studies used collagen tripeptide, 3g/d for 4 to 12 weeks, with notable improvement in skin elasticity and hydration. Lastly, one study using collagen dipeptide suggested anti-aging efficacy is proportionate to collagen dipeptide content.
CONCLUSIONS AND RELEVANCE: Preliminary results are promising for the short and long-term use of oral collagen supplements for wound healing and skin aging. Oral collagen supplements also increase skin elasticity, hydration, and dermal collagen density. Collagen supplementation is generally safe with no reported adverse events. Further studies are needed to elucidate medical use in skin barrier diseases such as atopic dermatitis and to determine optimal dosing regimens.
J Drugs Dermatol. 2019;18(1):9-16.
Kayla H. Felix MS,a Constance E. Ediale MS,a,b Amy J. McMichael MDa
A recombinant vaccine (HZ/su) was approved in 2017 to prevent herpes zoster (HZ) infection and associated sequelae with greater efficacy and safety than its live precursor. Though dermatologists regularly encounter patients with HZ infection, recommendation of vaccination by dermatologists and other physicians has been minimal in past years. Overall patient awareness and utilization of the HZ vaccines has subsequently been low. While HZ/su touts several improvements over the live vaccine, dermatologists still face obstacles to vaccine recommendation and administration including concerns of efficacy, limited availability, and complex cost and reimbursement for administration. Additionally, dermatologists have not historically played a systematic role in the recommendation and administration of vaccines. A review of literature was completed to identify the current role of dermatologists in HZ prevention, the efficacy and safety of HZ/su, potential barriers to recommendation by dermatologists, and the feasibility of vaccine administration in dermatology offices. Pubmed/MEDLINE was used as the primary search database. Ultimately, widespread encouragement of dermatologists to recommend vaccination against HZ is crucial, and dermatologists are in a prime position to make the vaccine more accessible to their patient population.
J Drugs Dermatol. 2019;18(1):18-22.
May Elgash BS,a Ncoza Dlova MBChB FCDerm PhD,b Temitayo Ogunleye MD,c Susan C. Taylor MDc
Seborrheic dermatitis is a common, relapsing, inflammatory skin condition of unclear etiology. The Malassezia yeast genus are believed to play a role. Seborrheic dermatitis commonly affects areas of the skin with high sebum production, including the scalp, nasolabial folds, glabella, eyebrows, beard, ears, retroauricular skin, sternum, and other skin folds. Seborrheic dermatitis may present differently in individuals with skin of color. Darker-skinned individuals may present with scaly, hypopigmented macules and patches in typical areas of involvement. Arcuate or petal-like patches may be seen, specifically termed petaloid seborrheic dermatitis. Children of color often do not experience the classic “cradle cap” appearance of seborrheic dermatitis, and have erythema, flaking, and hypopigmentation of the affected areas and folds of skin. Seborrheic dermatitis tends to respond well to conventional treatments, although it tends to recur. Skin of color patients may require a modified treatment approach which takes into account differences in hair texture and hair washing frequency. This paper aims to highlight these differences to help reduce disparities in the management of seborrheic dermatitis in patients of color.
J Drugs Dermatol. 2019;18(1):24-27.
BACKGROUND: Moisturizers create the illusion of smooth, soft skin by placing a temporary film over the skin surface or by imparting a transient hydration benefit that does not clinically improve the quality or appearance of skin.
OBJECTIVE: The objective of this 8-week study was to assess the clinically relevant effects of a 3-step facial treatment program to improve the multiple qualities of photoaged skin.
METHODS: Thirty-five female subjects were evaluated at baseline and after 2, 4, and 8 weeks. Measures included investigator and subject assessments and
RESULTS: This novel approach resulted in significant objective, subjective, and bio-instrumental improvements in the appearance and quality of photoaged skin. At the end of the study, the investigator efficacy assessments demonstrated significant reduction in roughness, sebum, redness, and dirt with improvement in skin dryness, moisturization, clarity, smoothness, softness, radiance, and overall appearance without use of a moisturizer. The treatment products were well-tolerated.
CONCLUSION: Use of this novel approach safely and effectively improved multiple clinical endpoints of photoaged skin through cleansing, aggressive exfoliation, and sebum reduction in the absence of a traditional moisturizer.
J Drugs Dermatol. 2019;18(1):28-31.
Fran E. Cook-Bolden MD,a Susan H. Weinkle MD,b Eric Guenin PharmD PhD,c Varsha Bhatt PhDd
BACKGROUND: Acne vulgaris (acne) is the most common dermatologic disease seen in a racially, geographically, politically, culturally, and socioeconomically diverse Hispanic population. Despite their growing demographics in the US, there are few studies evaluating acne treatment in this population. Potential for skin irritation and dryness, as well as pigmentary changes are key concerns. The first lotion formulation of tretinoin was developed using novel polymerized emulsion technology to provide an important alternative option to treat these acne patients who may be sensitive to the irritant effects of other tretinoin formulations.
OBJECTIVE: To determine the efficacy and safety of tretinoin 0.05% lotion in treating moderate-to-severe acne in a Hispanic population.
METHODS: Post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled Phase 3 studies in moderate or severe acne. Hispanic subjects (aged 11 to 50 years, N=766) were randomized (1:1) to receive tretinoin 0.05% lotion or vehicle, once-daily for 12 weeks. Efficacy assessments included changes in baseline inflammatory and noninflammatory lesions and treatment success (at least 2-grade reduction in Evaluator’s Global Severity Score [EGSS] and clear/almost clear). Safety, adverse events (AEs), and cutaneous tolerability were evaluated throughout using a 4-point scale where 0=none and 3=severe.
RESULTS: At week 12, mean percent reduction in inflammatory and noninflammatory lesion counts were 60.1% and 53.0%, respectively, compared with 51.1% and 38.7% with vehicle (P less than equal to 0.001) in the Hispanic population. Treatment success was achieved by 19.6% of subjects by week 12, compared with 12.7% on vehicle (P=0.015). The majority of AEs were mild and transient. There were four serious AEs (SAEs) reported (two each group) unrelated to treatment. Incidence of treatment-related AEs with tretinoin 0.05% lotion was lower than in the overall study population; the most frequently were application site pain (2.0%), dryness (1.4%), and erythema (1.2%). Local cutaneous safety and tolerability assessments were generally mild-to-moderate at baseline and improved by week 12. There were slight transient increases in scaling and burning over the first four weeks. Hyperpigmentation severity reduced progressively with treatment.
CONCLUSIONS: Tretinoin 0.05% lotion was significantly more effective than its vehicle in achieving treatment success and reducing inflammatory and noninflammatory acne lesions in a Hispanic population. The new lotion formulation was well-tolerated, and all treatment-related AEs were both mild and transient in nature.
J Drugs Dermatol. 2019;18(1):32-38.
Melanie D. Palm MD MBA,a Joel Schlessinger MD,b Valerie D. Callender MD,c Steven Fagien MD,d Kenneth Beer MD,e Suzanne Magante MS,f Sara Sangha PhDg
Perceptions of attractiveness can be negatively affected by submental fullness. Patients seeking to improve their submental contour have a variety of treatment options including surgical procedures, energy-based devices, and injectable treatment. The Condition of Submental Fullness and Treatment Outcomes Registry (CONTOUR) was designed to provide insights into the treatment of submental fat (SMF) in clinical practice. CONTOUR was a prospective observational study that enrolled 1029 adults at 91 sites in the United States and Canada. Patients were followed until treatment completion, discontinuation, or 1 year elapsed from enrollment without treatment. Final data from CONTOUR are reported here.
Of the 676 patients who underwent treatment, 570 were treated with ATX-101 (deoxycholic acid injection), 77 with energy-based devices, 23 with surgical liposuction, 5 with laser liposuction, and 9 with other treatments. The majority of treated patients were facial aesthetic treatment naive. A markedly greater percentage of patients with mild or moderate SMF at baseline received treatment with ATX-101 or energy-based devices, whereas the majority of patients undergoing liposuction had severe or extreme SMF. Physicians most frequently cited a preference for a noninvasive/minimally invasive procedure as the reason for choosing either ATX-101 or energy-based devices. The majority of patients were at least partially satisfied with results, regardless of the chosen treatment.
Data from CONTOUR indicate that cost is the most important factor in a patient’s decision to undergo treatment, that choice of treatment method is most influenced by SMF severity and preference for nonsurgical versus surgical intervention, and that the availability of noninvasive/minimally invasive options has made SMF treatment an attractive first procedure for patients who have not undergone previous facial aesthetic treatments.
ClinicalTrials.gov identifier: NCT02438813.
J Drugs Dermatol. 2019;18(1):40-48.
Martina Kerscher MD PhD,a Rungsima Wanitphakdeedecha MD MA MSc,b Ada Trindade de Almeida MD,c Corey Maas MD FACS,d and Jürgen Frevert PhDe
Aesthetic dermatologic applications of botulinum neurotoxin (BoNT), including treatment of glabellar lines, horizontal forehead lines, and crow’s feet, were the most common non-surgical cosmetic procedures in the US in 2017, with high levels of subject satisfaction. Since the first BoNT type A (BoNT-A) formulation was approved in 1989, the number of formulations available on the world’s commercial markets has increased and new approvals are expected. BoNT is produced by Clostridium botulinum in nature as part of a large protein complex. However, the unnecessary clostridial proteins, which dissociate from BoNT under physiological conditions with a half-life of less than 1 minute, have no role in clinical applications. Data demonstrate that BoNT administration can elicit an immunological response, leading to production of neutralizing antibodies that can be associated with reduced efficacy or treatment non-response. As repeat treatments are required to maintain efficacy, clinicians should be aware of the possibility of antibody development and choose a BoNT with the lowest risk of immunogenicity. IncobotulinumtoxinA is manufactured using advanced technology to precisely isolate the pure BoNT without unnecessary clostridial proteins, and with low immunogenicity and high specific activity. In incobotulinumtoxinA clinical studies, no previously BoNT-naïve subjects developed neutralizing antibodies, and there was no secondary non-response to incobotulinumtoxinA treatment. Here we review the role of unnecessary clostridial proteins in BoNT-A and discuss the unique incobotulinumtoxinA manufacturing and purification process with a focus on the implications for use in aesthetic medicine.
J Drugs Dermatol. 2019;18(1):52-57.
Amir Moradi MDa and Steven F. Weiner MDb
BACKGROUND: The safety and effectiveness of high-intensity precision radiofrequency (RF) for rejuvenating the aging neck and face, and of fractional laser therapy for treating photodamaged skin have each been previously demonstrated.
OBJECTIVE: To assess the effects of combining high-intensity precision RF and fractional laser therapy for treating the aging face and neck.
Methods and Materials: Subjects (N=19) with Fitzpatrick skin types I to VI and mild-to-moderate solar elastosis and sun or age-related pigmentation on the face and/or neck were sequentially treated with high-intensity precision RF and fractionated laser devices during the same session. Three sessions were completed 30 days apart. Assessments were made 90 days after the last treatment.
RESULTS: Both Clinician and Subject Global Assessment of Improvement scores indicated clinical improvement (n=16, 84%) or no change (n=3, 16%) in skin quality. Clinical improvement was also observed in 16 subjects (68%) in masked assessment. Most subjects (90%) noted improved skin quality and 74% expressed at least some satisfaction with their treatment results. The most common adverse events were erythema (n=57, 45%) and edema (n=45, 35%).
CONCLUSION: The results of this study establish the safety and effectiveness of combined treatment with a 1927 nm thulium laser and a high-intensity precision RF device.
ClinicalTrials.gov Identifier: NCT03409965.
J Drugs Dermatol. 2019;18(1):59-64.
Leslie S. Baumann MD FAAD,a Edmund M. Weisberg MS MBE,b Melissa Mayans,a Erika Arcuria
OBJECTIVE : To study the safety, efficacy, optimal volume, and longevity of an injectable hyaluronic acid (HA) gel dermal filler to treat facial temporal fossa fat loss.
METHODS AND MATERIALS: This open-label, single-site, 12-month study used 20 mg/mL HA gel to correct volume loss in both temples in 30 subjects. Touch-ups were allowed at week 2. At each visit, the investigator completed a Frontal Temporal Fossa Scale and a 7-point satisfaction scale. Subjects completed a 7-point satisfaction scale, Subject Global Aesthetic Improvement Scale (GAIS), and self-perception of age assessment. Photos were taken at each visit.
RESULTS: Subjects who returned for the one-month visit (29) achieved a ≥ 1-point improvement on the Temporal Fossa Scale in both temples. At month 12, 98% of the temples maintained a ≥ 1-grade, 18% showed a 3-grade, 34% showed a 2-grade, and 46% showed a 1-grade improvement. All subjects received an average of 1.1 mL per temple. Mild to moderate jaw pain after injections was noted by 40% of patients. The pain was reported to occur during mastication. There was no correlation between the amount of the study device injected and the incidence of jaw pain, which did not occur at the touch-up injections and was self-limited. Injections were well tolerated, and no patients developed vascular compromise, vascular events, or visual disturbances.
CONCLUSION: HA gel (20 mg/mL) is safe and efficacious when used in the facial temporal fossa. The results lasted at least 12 months in 98% of subjects. Most subjects perceived themselves as looking younger than at baseline.
J Drugs Dermatol. 2019;18(1):67-74.
José Raúl Montes MD FACS FACCS and Elizabeth Santos DrPH
BACKGROUND: A device that uses microfocused ultrasound with visualization (MFU-V) is cleared in the United States and European Union as a noninvasive procedure that lifts and tightens the skin (Ultherapy® System; Merz North America, Raleigh, NC, USA). The objective of this patient survey was to obtain more in-depth information on patient satisfaction during the MFU-V treatment procedure and satisfaction with their aesthetic results.
METHODS: Survey participants had received MFU-V treatment and completed at least 6 months of follow-up. A hyperlink to an online survey was distributed via email and respondents completed the survey anonymously. The satisfaction survey consisted of 13 questions related to the treatment process and post-treatment outcomes. A validated Age Appraisal Visual Analog Scale was also included to evaluate patient pre- and post-treatment self-assessments of their age.
RESULTS: The survey was completed by 52 patients, and the majority of surveyed patients received treatment on the lower face (100%) and submentum (92.3%). Many patients (41%) reported their treatment outcome met or exceeded their expectation. About one-half of patients (n=27; 52%) needed a follow-up appointment with photos to be able see post-treatment changes. Following MFU-V treatment, 50% believed they looked 1 to 15 years younger. Most (73%) would recommend MFU-V to others.
CONCLUSION: About half of patients undergoing MFU-V were Very Satisfied or Satisfied with their results and a large number reported their treatment outcome met or exceeded their expectations. The number of follow-up appointments appeared to be related to patient satisfaction. Treatment with MFU-V is very well tolerated.
J Drugs Dermatol. 2019;18(1):75-79.
Ronald B. Vender MD FRCPC,a Anneke Andriessen PhD,b Benjamin Barankin MD FRCPC,c Anatoli Freiman MD FRCPC,c Dimitrios Kyritsis MD FRCPC,d Loukia-Maria Mistos MD FRCPC,d Jennifer Salsberg MD FRCPC,e Laetitia Amar MDf
INTRODUCTION: The skin of subjects with dry, flaking, and/or scaling conditions is characterized by decreased water and skin lipids content among other findings. It is well understood that daily use of gentle cleansers and moisturizers may help to restore and maintain an optimal skin barrier function.
A cohort study of patients with dry skin was developed to evaluate efficacy of daily use of a ceramide containing cleanser and cream that also has salicylic acid.
METHODS: Thirty-five adults with mild-to-moderate dry skin conditions were recruited from four dermatology centers in Canada. With consent, the subjects received twice daily treatment with the ceramides containing cleanser and cream that also has salicylic acid. Physician and subject assessed skin condition comparing baseline versus (day 0) versus day 28 (end) was scored using the Dry skin classification scale and the Global Aesthetic Improvement Scale (GAIS). Subjects also rated satisfaction, product features, quality of life aspects, safety, and tolerability.
RESULTS: Thirty-four subjects completed the treatment and study period; one was lost to follow up. Daily use of the evaluated cleanser and moisturizer significantly improved skin condition when comparing day 0 versus day 28 (+/- 5 days (end)) results. Both the physicians and subjects using the dry skin classification scale and GAIS scored a significant improvement of the dry skin condition. After treatment subjects reported a significant improvement in the quality of their professional life, self-image, and social life. The products were shown to be safe, comfortable, and well tolerated.
CONCLUSION: The results indicated the cleanser and moisturizer to offer an effective, easy and comfortable option for dry skin conditions.
J Drugs Dermatol. 2019;18(1):80-85.
BACKGROUND: Calcium hydroxylapatite (CaHA, Radiesse®) with integral 0.3% lidocaine (CaHA(+)) has recently been approved for use in aesthetic medicine. This study assessed the performance of CaHA(+) in subjects undergoing treatment for facial volume loss and evaluated subject and physician satisfaction.
METHODS: In a prospective, open-label, post-marketing study, 25 women seeking treatment for age-related facial volume loss received CaHA(+) injections in 1–3 facial areas including the cheeks, marionette lines, prejowl sulcus, and jawline. Subjects returned for follow-up at 14 and 120 days, with the option of touch-up injections at day 14 if required to achieve optimal correction. Filler performance was assessed using the Merz Aesthetics Scales (MAS) and subject satisfaction using the Global Impression of Change Scale (GICS). Physician satisfaction was assessed in terms of CaHA(+)-related properties (eg, ease of injection, distribution, positioning) and aesthetic outcomes. Adverse events were recorded.
RESULTS: Mean MAS scores at baseline were ~2 corresponding to moderate facial volume loss/sagging in the treated area. At day 14, the mean score had improved to less than equal to 1.4 for all treated areas, indicating mild volume loss. At day 120, mean scores had further improved to less than equal to 1.1. At both follow-up visits, mean GICS scores were less than equal to 2 indicating facial appearance was ‘much improved’ compared with baseline. All subjects reported willingness to repeat treatment and recommend it to family/friends. Physician ratings were high for ease of CaHA(+) injection, distribution, positioning, sculpturing outcome, and effect on skin tension. Compared to CaHA without lidocaine, the physician rated CaHA(+) as better or similar in performance. Adverse events were mostly mild and expected with CaHA and filler injections in general.
CONCLUSION: The well-established efficacy and safety profile of CaHA appears unchanged by the addition of integral lidocaine. CaHA(+) was effective for volume enhancement in a number of facial areas and associated with high subject and physician satisfaction.
J Drugs Dermatol. 2019;18(1):86-91.
Alessandra Haddad MD PhD,a,b Ana Paula Gomes Meski MD,c Camila Cazerta MD,d Christine Guarnieri MD,d Eliandre Palermo MD,d Juliana Sarubi MD,e Luciana Lourenço MD PhD,d Luiz Eduardo Avelar MD,e Marcus Henrique Morais MD,e Maria Alice Gabay MD,f Meire Brasil Parada MD,d Rodrigo Ferraz MD,e Rodrigo Maia MD,e Danielle Shitara MD PhDd
The number of cosmetic filler and botulinum toxin options available in the Brazilian market has increased over the past years. With a wide variety of therapeutic options, some challenges have arisen: designing an adequate treatment plan, electing the most suitable procedures for the patient, taking into consideration the rheological characteristics of the products, considering the amount needed to achieve a natural look, but also defining the safest way to deliver the treatment. Aging of the facial structural tissue layers occurs at a different pace and the requirements for the aesthetic approach of a 30-year-old patient are different from a 60-year-old patient. A group of twelve experts in minimally invasive injectable procedures sought to identify common changes observed in different age groups in order to help in establishing a plan of treatment for patients of different ages. The individualized aesthetic plan should consider the main pillars of the aesthetic treatment -- aging process, facial assessment, and facial anatomy, to identify and systematize common changes observed in different age groups, as well as the safest and most reproducible techniques, especially for new injectors.
J Drugs Dermatol. 2019;18(1):92-102.