Open Label Study Evaluating Efficacy, Safety, and Effects on Perception of Age After Injectable 20 mg/mL Hyaluronic Acid Gel for Volumization of Facial Temples

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.

Safety and efficacy of hydrogen peroxide topical solution, 40% (w/w), in patients with seborrheic keratoses: Results from 2 identical, randomized, double-blind, placebo-controlled, phase 3 studies (A-101-SEBK-301/302).

BACKGROUND: Approved topical treatments for seborrheic keratoses (SKs) are an unmet need. OBJECTIVE: To evaluate the safety and efficacy of 40% hydrogen peroxide topical solution (HP40) versus vehicle for the treatment of SKs (A-101-SEBK). METHODS: A total of 937 patients with 4 SKs each (≥1 lesion each on the face and on the trunk and/or an extremity) were randomized 1:1 to HP40 or vehicle. At each visit, SKs were graded using the Physician's Lesion Assessment (PLA) scale (0, clear; 1, nearly clear; 2, ≤1 mm thick; and 3, >1 mm thick). After 1 treatment, SKs with a PLA score higher than 0 were re-treated 3 weeks later. RESULTS: At day 106, significantly more patients treated with HP40 than with vehicle achieved a PLA score of 0 on all 4 SKs (study 1, 4% vs 0%; study 2, 8% vs 0% [both P < .01]) and on 3 of 4 SKs (study 1, 13% vs 0%; study 2, 23% vs 0% [both P < .0001]). A higher mean per-patient percentage of SKs were clear (study 1, 25% vs 2%; study 2, 34% vs 1%) and clear or nearly clear (study 1, 47% vs 10%; study 2, 54% vs 5%) with HP40 than with vehicle. Local skin reactions were largely mild and resolved by day 106. LIMITATIONS: The optimal number of treatment sessions was not evaluated. CONCLUSION: Application of HP40 was well tolerated and effective in the removal of SKs.

Nonprescription topical treatments for skin rejuvenation.

Topical skin care regimens are a mainstay treatment for aging skin. All patients seeking skin rejuvenation can benefit from this low-risk intervention. This article reviews available nonprescription topical treatments for rejuvenation including moisturizers, antioxidants, retinols, and sunscreen.

Comparison of clindamycin 1% and benzoyl peroxide 5% gel to a novel composition containing salicylic acid, capryloyl salicylic acid, HEPES, glycolic acid, citric acid, and dioic acid in the treatment of acne vulgaris.

This study evaluated the tolerance and efficacy of 2 facial skin products in subjects with acne using the following acne treatments: 1) treatment A, a combination of salicylic acid, capryloyl salicylic acid, HEPES, glycolic acid, citric acid, and dioic acid, and 2) treatment B (BenzaClin®, clindamycin 1% and benzoyl peroxide 5% gel). The treatment design included the split-face application of treatment A and treatment B and the full-face application of the cleanser, moisturizer, and sunscreen. Data were collected through physician visual assessments, subject irritation questionnaires and assessments, along with clinical photography. Results showed similar tolerance and efficacy for both treatments.

Effects of lavender olfactory input on cosmetic procedures.

OBJECTIVES: To evaluate the effects of the aroma of essential oil of lavender against placebo on subjects' pain perceptions and levels of anxiety when undergoing elective cosmetic facial injections of botulinum toxin type A (BOTOX(®) COSMETIC) for the correction of glabellar wrinkles. METHODS: Subjects (N=30) who had not previously received any cosmetic facial injections were randomized to essential oil of lavender aroma exposure or to placebo during elective cosmetic facial injections of BOTOX(®) (12 U) for the correction of glabellar wrinkles. Evaluations of subjects' pain perceptions and levels of anxiety assessed by the Spielberger State-Trait Anxiety Inventory, heart rate (HR), and blood pressure (BP) measurements were taken at baseline, before, and after injections. RESULTS: Subjects exposed to essential lavender oil showed a significant reduction in HR after the injection as compared to the pre-injection HR. Subjects exposed to the placebo did not show any significant difference in BP or HR between pre-injection and postinjection. CONCLUSIONS: Although essential oil of lavender did not have an effect on the subjects' perception of pain during a facial injection, subjects showed significant increases in parasympathetic activity when exposed to the lavender aroma. Lavender aromatherapy has the potential to ease anxiety in patients undergoing minimally invasive facial cosmetic procedures.

Safety and efficacy of a rapid-acting topical 4% lidocaine gel in a unique drug delivery system.

BACKGROUND: Ideally, topical anesthetics should provide rapid analgesic action without causing toxic blood levels of lidocaine or other side effects. Various formulations of lidocaine as a topical anesthetic have been tested and are currently on the market. Here, the authors report on a topical lidocaine with a novel delivery system that provides a rapid onset of action without toxic plasma els of lidocaine. OBJECTIVE: Study 1 assessed the time needed for a topical 4% lidocaine gel with a unique drug delivery system to produce optimal anesthetic effects. Study 2 assessed lidocaine plasma concentrations and assessed the time to maximal anesthetic effect. METHODS: In both studies, subjects received six botulinum toxin type A injections for crow's feet wrinkles in six separate zones in the lateral periocular regions bilaterally. The first injection was administered in the absence of topical 4% lidocaine gel. Gel was then applied to the remaining five zones and injections were given at set time points out to 45 minutes. In study 2, blood samples were taken from baseline to 60 minutes. RESULTS: Significant anesthetic effect with topical 4% lidocaine gel was attained without occlusion in approximately 25-30 minutes. However, optimum effects were observed between 35-40 minutes after application. Additionally, topical 4% lidocaine, when used appropriately, did not produce lidocaine plasma levels associated with toxicity. CONCLUSION: Topical 4% lidocaine gel with a unique drug delivery system produces significant anesthesia without occlusion in approximately 25-30 minutes with optimal effects observed between 35-40 minutes after application. Topical 4% lidocaine gel can be used effectively and safely as a topical anesthetic in the physician's office.

Novel hyaluronic acid dermal filler: dermal gel extra physical properties and clinical outcomes.

BACKGROUND: Dermal gel extra (DGE) is a new, tightly cross-linked hyaluronic acid (HA)-based dermal filler containing lidocaine engineered to resist gel deformation and degradation. OBJECTIVES: To develop a firmer gel product (DGE) and compare the efficacy and safety of DGE with nonanimal stabilized HA (NASHA) for correction of nasolabial folds (NLFs). METHODS: DGE physical properties were characterized, and 140 subjects with moderate to deep NLFs were treated with DGE and NASHA in a randomized, multicenter, split-face design study. Efficacy, pain, and satisfaction were measured using appropriate standard instruments. Adverse events were monitored throughout the study. RESULTS: DGE has a higher modulus and a higher gel:fluid ratio than other HA fillers. Similar optimal correction was observed with DGE and NASHA through 36 weeks (9 months). Study subjects required less volume (p<.001) and fewer touch-ups (p=.005) and reported less injection pain (p<.001) with DGE treatment. Most adverse events were mild to moderate skin reactions. CONCLUSIONS: DGE is a firm HA gel that required significantly less volume and fewer touch-ups to provide equivalent efficacy to NASHA for NLF correction; both dermal gels were well tolerated. DGE will provide a comfortable and cost-effective dermal filler option for clinicians and patients.

Striae distensae (stretch marks) and different modalities of therapy: an update.

BACKGROUND: Striae distensea (SD; stretch marks) are a well-recognized, common skin condition that rarely causes any significant medical problems but are often a significant source of distress to those affected. The origins of SD are poorly understood, and a number of treatment modalities are available for their treatment, yet none of them is consistently effective, and no single therapy is considered to be pivotal for this problem. With a high incidence and unsatisfactory treatments, stretch marks remain an important target of research for an optimum consensus of treatment. OBJECTIVE: To identify the current treatment modalities and their effectiveness in the treatment of stretch marks. MATERIALS AND METHODS: Review of the recent literature regarding clinical treatment of stretch marks with emphasis on the safety and efficacy of the newer optical devices and laser applications. RESULTS: No current therapeutic option offers complete treatment, although there are a number of emerging new modalities that are encouraging. CONCLUSION: The therapeutic strategies are numerous, and no single modality has been far more consistent than the rest. The long-term future of treatment strategies is encouraging with the advance in laser technologies.

A ciência do cosmecêutico: cosmético ou droga? / The cosmeceutical science: cosmetic or drug?

A indústria de produtos para cuidados com a pele cresce rapidamente e não há dúvidas sobre o enorme benefício desses produtos na rotina de cuidados diários na vida moderna, mas não existe nenhum reconhecimento legal dessa categoria quando comparamos com a definição legal de um cosmético ou de uma droga. Este artigo discute essa gama de produtos que fica entre os cosméticos (função decorativa) e as drogas (alterando a estrutura e a função da pele). Na verdade, os cosmecêuticos não são inofensivos como um cosmético, mas também não são medicamentos.

Sistema Baumann de classificação da pele / Baumann skin typing system

Este artigo descreve os quatro parâmetros que embasam o Sistema Baumann de Classificação da Pele (BSTS), definindo e resumindo as características dos 16 tipos de pele.

Evaluation of liposomal delivery system for topical anesthesia.

Local anesthesia is an integral aspect of cutaneous surgery. Its effects provide a reversible loss of sensation in a limited area of skin, allowing dermatologists to perform diagnostic and therapeutic procedures safely, with minimal discomfort and risk to the patient. Moreover, the skin acts as a major target as well as principle barrier for topical/transdermal (TT) drug delivery. The stratum corneum (SC) plays a crucial role in barrier function for TT drug delivery. Despite the major research and development efforts in TT systems and their implementation for use of topical anesthetics, low SC permeability limits the usefulness of topical delivery, which has led to other delivery system developments, including vesicular systems such as liposomes, niosomes, and proniosomes, with effectiveness relying on their physiochemical properties. This review gives indepth coverage of liposomes and their use as a delivery route for topical anesthetics.

Innovations in natural antioxidants and their role in dermatology.

The use of natural products for skin care has become more common in the past few years. Consumers are more aware of unnatural chemicals and other toxins and are searching for natural products to use on their skin. Fortunately, a large number of botanical antioxidants exist and are being marketed as either over-the-counter or prescription skin care products. Antioxidants can have profound effects on the intracellular signaling pathways involved in skin damage and thus may be protective against photodamage as well as may prevent wrinkles and inflammation. This supplement discusses the potent effect that botanical antioxidants may have in the management of a broad range of skin issues, from photoaging to inflammatory skin conditions.

Comparison of smooth-gel hyaluronic acid dermal fillers with cross-linked bovine collagen: a multicenter, double-masked, randomized, within-subject study.

BACKGROUND: A new family of next-generation non-animal hyaluronic acid (HA) dermal fillers was approved by the FDA in June 2006. Compared with other HA fillers available in the United States at the time of writing, these new fillers have a higher concentration of HA, higher concentration of cross-linked HA, and a smooth consistency--which should promote long-lasting corrections and a smooth, natural look and feel postinjection. OBJECTIVE: The objective was to compare the effectiveness and safety of these smooth-gel HA dermal fillers with bovine collagen for nasolabial fold (NLF) correction. METHODS AND MATERIALS: A total of 439 subjects with moderate or severe NLFs received one of three types of smooth-gel HA dermal filler (in one NLF) and cross-linked bovine collagen (in the other NLF) and were evaluated for or=6 months. Up to 88% of subjects preferred the HA dermal fillers over bovine collagen. All fillers were similarly well tolerated. CONCLUSION: The smooth-gel HA dermal fillers offer longer-lasting correction than bovine collagen-which may lessen the frequency that repeat treatments are needed. Also, they were preferred by the vast majority of subjects-which should promote patient satisfaction.

Less-known botanical cosmeceuticals.

Complementary and alternative medicine (CAM) has become increasingly popular in the United States during the last 10-15 years. The use of oral and topical supplements falls within this framework. Most oral and topical supplements are based on or include several botanical ingredients, many of which have long histories of traditional or folk medicine usage. Several of the available products derived from botanical sources are touted for their dermatologic benefits. The focus in this discussion will be on a select group of botanical compounds that have been used for dermatologic purposes or show promise for such applications, including: rosemary, polypodium leucotomos, propolis, oatmeal, olive oil, grape seed extract, lavender, mushrooms, and coffeeberry. Other more commonly used products of botanical origin, such as arnica, bromelain, caffeine, chamomile, ferulic acid, feverfew, green tea, licorice, pomegranate, and resveratrol, are also briefly considered.

Botulinum toxin-B and the management of hyperhidrosis.

A new serotype of botulinum toxin has recently arrived in the US. Botulinum toxin type B (BTX-B), known as Myobloc in the United States and as Neurobloc in Europe, is one of seven different antigenic members of the botulinum toxin family, five of which the human nervous system is susceptible to. Like botulinum toxin type A (BTX-A), BTX-B has been used for a myriad of both dermatologic and nondermatologic problems since its recent approval by the FDA for the treatment of cervical dystonia in December 2000. It is currently not approved however, for a cosmetic use but has been used for this purpose in an "off-label" fashion. It has followed in the therapeutic footsteps of BTX-A in the prevention and treatment of facial wrinkles such as crow's feet and glabellar frown lines. In addition, one of its current and popular uses is in the management of hyperhidrosis, a disease in search of a long needed treatment. This past year researchers have been investigating the efficacy as well as defining the dosing and application regiments of BTX-B in the treatment of hyperhidrosis. In addition, recent studies have been examining its side effect profile, which may be very different than that seen with BTX-A. There are only a handful of studies in the literature examining the cosmetic applications of BTX-B. This chapter will review what is currently known about BTX-B and its current use in regards to the treatment of hyperhidrosis.

Lip silicone granulomatous foreign body reaction treated with aldara (imiquimod 5%).

We report a case of a lip granulomatous reaction after injection of silicone being treated successfully with topical Aldara (Imiquimod 5%). Silicone granulomas and the inflammatory foreign body reaction that can occur are some of the complications that arise from using silicone for cosmetic enhancement. The inflammatory reaction of this patient first appeared shortly after silicone injection of both the upper and lower lips. Histopathologic examination revealed a foreign body inflammatory reaction that is consistent with silicone granuloma. Although this reaction has been described extensively in the dermatologic literature as one of the disfiguring side effects of silicone injection, its treatment has plagued cosmetic dermatologists. We report the use of an immunomodulatory cream Aldara (Imiquimod 5%) to treat this type of reaction.