A Randomized, Double-Blind Trial to Investigate the Equivalence of IncobotulinumtoxinA and OnabotulinumtoxinA for Glabellar Frown Lines.

BACKGROUND: IncobotulinumtoxinA and onabotulinumtoxinA are indicated for the temporary improvement in the appearance of glabellar frown lines (GFL). This is the first randomized direct comparator study to date, at the Food and Drug Administration-recommended dose of 20 units (U), for the treatment of GFL. OBJECTIVE: To investigate the dose equivalence of incobotulinumtoxinA (20 U) and onabotulinumtoxinA (20 U) for the treatment of moderate-to-severe GFL. MATERIALS AND METHODS: Prospective, randomized (1:1), double-blinded, parallel-group study in 250 females (18-50 years), employing a single treatment with incobotulinumtoxinA or onabotulinumtoxinA, followed by a 4-month observational period. RESULTS: At the primary efficacy endpoint (1 month after treatment), incobotulinumtoxinA was equivalent to onabotulinumtoxinA in the treatment of GFL at the 20 U dose within the prespecified ± 15% margin of equivalence. Efficacy remained similar between treatment groups through 4 months after treatment as assessed by the independent masked panel and the masked treating physicians. Patient satisfaction ratings were similar between groups and favorable (>90%) throughout. Both treatments were well tolerated. CONCLUSION: Equivalence was demonstrated at the primary endpoint between incobotulinumtoxinA and onabotulinumtoxinA in the treatment of GFL at the 20 U dose at 1 month. Similar efficacy and tolerability profiles were observed through 4 months after treatment.

The Potential Role of Topically Applied Heparan Sulfate in the Treatment of Photodamage.

Heparan sulfate is an essential glycosaminoglycan that plays important roles in development, homeostasis, and disease. As a group, the glycosaminoglycans provide mechanical strength to skin, as they can absorb water and occupy the space between elastin fibers and collagen. Heparan sulfate is also a key participant in cell proliferation, cell migration, collagen fiber formation, basement membrane regeneration, granulation tissue formation, and cell adhesion associated with wound healing. A variety of dermatological disorders are associated with changes in glycosaminoglycans or their associated proteoglycans. A new topical formulation of low molecular weight heparan sulfate glycosaminoglycan has been shown to penetrate the epidermis, basement membrane, and dermis within 24 hours of application. In an 8-week study, 15 patients using this new formulation showed improvement in skin hydration, skin firmness, skin elasticity, skin barrier function, and global fine lines and wrinkles. Incorporating low molecular weight heparan sulfate into topically applied formulations may represent a new approach to improving the appearance of photodamaged skin.

Current and new treatments of photodamaged skin.

Patients with photodamaged skin need guidance in selecting treatment plans that optimize outcomes, minimize downtime, and reduce adverse effects. The gold standard among cosmeceuticals is the topical retinoids, such as tretinoin. A topical formulation of folic acid and creatine appears to be a viable treatment option for the treatment of photodamaged skin. The use of specific topical cosmeceuticals in combination with nonablative photorejuvenation is recommended in choosing modalities that address the concerns of the patient. A combination of intense pulsed light (IPL), low-intensity diode light, and biostimulating drugs has been shown to provide results superior to those of IPL alone for photorejuvenation. Photodynamic therapy (PDT) with 5-aminolevulinic acid (5-ALA) is the treatment of choice for type C photodamage. Low-strength 5-ALA (1 to 2%) applied several times, every 10 to 15 minutes, and incubated for 30 to 60 minutes with 550 to 630 nm, 530 to 1200 nm, or 570 to 1200 nm light activation improved hyperpigmented lesions, skin smoothing, and skin elasticity with high patient satisfaction. The use of 0.5% liposome-encapsulated 5-ALA spraying has been shown to be an alternative to 20% 5-ALA in a cream base in patients undergoing photorejuvenation. Adipose-derived stem cells and their derived secretory factors may have potential as treatments of photodamage.

Combination hand rejuvenation procedures.

Although the hands age at the same rate as the face, the aging process differs and requires a combination treatment approach for optimal rejuvenation. Photoaging causes epidermal changes such as lentigines, actinic keratoses, fine wrinkles, and crepe-like textural change. Thinning of the dermis and subcutaneous fat occurs as a result of both ultraviolet light exposure and intrinsic aging. This process can lead to a skeletal appearance of the hands, with prominent veins and bulging tendons. The combination approach addresses all of these issues, employing lasers, intense pulsed light devices, fractional devices, fillers, peels, vein sclerotherapy, and an effective at-home skin care program as indicated for individual needs and concerns.

Photopneumatic technology for the treatment of acne vulgaris.

OBJECTIVE: Treatment of acne vulgaris with light sources necessitates multiple targets including Propionibacterium acnes and sebaceous glands. Traditional light sources such as blue light capitalize on P acnes bacteria as targets while infrared lasers and radiofrequency devices target the sebaceous gland. A novel device combining vacuum and a unique broadband light source was designed to combine multiple targets for the effective treatment of acne. The objective of this study was to demonstrate the safety and efficacy of a novel device that uses a combination of broadband light and pneumatic energy for the treatment of acne vulgaris. METHODS: In a retrospective multicenter study, clinical data were collected from 56 patients with mild to severe acne. Patients had been treated 2 to 4 times with a portable photopneumatic device (Aesthera PPx, Aesthera Corporation, Pleasanton, CA) that delivers broadband light (400 to 1200 nm) to the treatment site via a hand piece. For 11 of the 56 patients, 3 independent physicians blinded to the study treatment or duration evaluated PPx efficacy by comparing photographs taken before and after PPx treatment. RESULTS: For the 56 patients, the median physician-rated clearance increased from 50% after a single treatment to 90% after the fourth treatment, whereas the median patient-rated clearance improved from 50% after a single treatment to 78% after the fourth treatment. On a 4-point scale, both physician-rated and patient-rated median overall satisfaction levels increased from a 3 after a single treatment, to 4 after the second, third, and fourth treatments. Clinically significant adverse events were not observed. For the 11 patients evaluated by photography, the median papule and pustule lesion counts decreased from 8 to 3 and from 2 to 0, respectively. Median acne severity (Burton scale) decreased from 4 before treatment to 2 after the final treatment, and the median improvement was 4.5 (scale 1-5). The median erythema rating decreased from 2 before treatment to 1 after the final treatment (scale 1-4). Adverse events were limited to mild erythema. The median acne clearance was 3 (scale 1-4). CONCLUSION: Photopneumatic technology provides a safe and effective treatment of mild to severe acne vulgaris.

BPX-01 Minocycline Topical Gel Shows Promise for the Treatment of Moderate-to-severe Inflammatory Acne Vulgaris.

Background and objectives: Acne vulgaris is a highly prevalent and multifactorial skin disorder that can adversely impact health-related quality of life. Factors that contribute to the pathogenesis of acne include pilosebaceous proliferation of proinflammatory Propionibacterium acnes (P. acnes) bacteria, presence of circulating androgens, excess sebum production, abnormal follicular keratinization, and multiple inflammatory cascades. Oral tetracyclines-especially doxycycline and minocycline-are frequently prescribed for the treatment of moderate-to-severe acne, given their anti-inflammatory properties and their effect on P. acnes reduction. Notwithstanding their established efficacy in the management of acne vulgaris, there is a desire to limit systemic exposure to antibiotics given growing concerns regarding bacterial resistance as well as the potential for serious side effects. This report describes outcomes of two randomized, vehicle-controlled trials (Phases IIa and IIb) of BPX-01, a topical minocycline gel, in the treatment of moderate-to-severe acne. Methods: In Study 1 (NCT02709096), at a single center, 33 subjects with highly fluorescing facial skin were randomized 2:1 to BPX-01 1% or vehicle control once-daily treatment for four weeks. Changes in P. acnes quantitative bacteriological cultures were assessed, as well as cutaneous tolerance to the study drug by both subjects and the investigator. In Study 2 (NCT02815332), subjects with moderate-to-severe inflammatory nonnodular acne (n=226) at 15 centers were randomized 1:1:1 to treatment with BPX-01 1%, BPX-01 2%, or vehicle control once-daily for 12 weeks. The primary endpoint was reduction in the number of inflammatory lesions; other endpoints included the number of noninflammatory lesions, Investigator's Global Assessment (IGA) of severity, and subjective ratings (investigator and subject) of acne. In both studies, cutaneous tolerability and safety were assessed, and plasma minocycline levels were tracked with a highly sensitive assay. Results: In Study 1, BPX-01 treatment reduced P. acnes colonization by 90.9 percent, which exceeded the reduction in the vehicle control group (65.53%; p=0.020). In Study 2, treatment with BPX-01 2% reduced the number of inflammatory lesions by 58.5 percent, exceeding the reduction in the vehicle control group (43.8%; p=0.0256). Trends toward an improvement preferential to BPX-01 2% were observed in the other endpoints. Across both studies, BPX-01 treatment was well-tolerated, with no photosensitivity, postinflammatory hyperpigmentation, or skin discoloration reported. A single subject (out of 259 study participants ) was identified to have detectable levels of plasma minocycline at low levels (42ng/mL) after 12 weeks of treatment but had no signs or symptoms associated with systemic administration of minocycline. Conclusion: BPX-01 appears to exhibit an effectiveness profile for reduction of inflammatory (nonnodular) acne lesions similar to that of oral minocycline formulations. However, because BPX-01 is topical and exhibits negligible systemic exposure, the likelihood of adverse events associated with oral minocycline use is much lower. These results demonstrate effectiveness of BPX-01 topical minocycline gel in reducing P. acnes colonization, suggesting that the BPX-01 2% formulation is a promising treatment for moderate-to-severe nonnodular, inflammatory acne vulgaris in both reduction of inflammatory lesions and also overall improvement in facial acne according to IGA.

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.

Noninvasive Submental Fat Compartment Treatment.

BACKGROUND: KYBELLA, ATX-101, is an injectable form of sodium deoxycholic acid. It is currently the only Food and Drug Administration-approved injectable drug for the reduction of submental fat. OBJECTIVES: A literature review and discussion of the treatment of submental fat. RESULTS: KYBELLA is a well-tolerated alternative for the treatment of submental fat. CONCLUSIONS: KYBELLA is a safe and efficacious, first in class, injectable drug for the reduction of submental fat.

Photopneumatic technology used in combination with profusion therapy for the treatment of acne.

BACKGROUND: Topical and oral medications, such as retinoids, benzoyl peroxide, antibiotics, and isotretinoin, have been the standard of care for the treatment of mild-to-moderate acne for the last several decades. More recently, a number of pubHshed studies on optical treatments, such as ultraviolet light, visible (blue) light, and intense pulsed Hght systems, have also shown clinical improvement in the appearance of acne. Specifically, photopneumatic technology, which utilizes gentle pneumatic energy (vacuum) to draw the target tissue into the treatment tip and then deHver broadband pulsed Hght to the dermal targets, has demonstrated marked improvement in the appearance of acne lesions and side effects associated with acne. OBJECTIVE: To demonstrate the safety and efficacy of using a combination treatment of the photopneumatic system and profusion therapy using three currently marketed topical agents for the treatment of mild-to-moderate acne on the face and/or body, including neck, chest, or back. METHODS: A prospective, multicenter, dinical trial of 41 individuals with mild-to-moderate acne was performed. Patients received up to four treatments at 1- to 2-week intervals with the photopneumatic system and profusion therapy with three separate topical agents. Study investigators and subjects evaluated dinical efficacy at 1-month and 3-month follow-up visits. RESULTS: At three months, a 69-percent reduction was noted in inflamed acne lesions and a 41-percent reduction in noninflamed acne lesions was noted by physician assessment. Additionally, at this same time point, subjects reported moderate-to-marked (26-75%) improvement in acne lesions. Eighty-one percent of subjects (22/27) were either satisfied or very satisfied with treatment outcome. There were no adverse events caused by malfunction of the device, and no serious adverse events or deaths. CONCLUSION: The results, as well as the reported patient satisfaction and safety, suggest that the treatment of acne with the photopneumatic system in combination with profusion using currently available topical acne agents demonstrated significant treatment results.

Multimodal treatment of acne, acne scars and pigmentation.

Acne is a common skin disease that affects nearly 80% of adolescents and young adults aged 11 to 30 years. Lesions appear primarily on the face, back, chest, and other areas with a high concentration of pilosebaceous glands. The development of inflammatory lesions often drives acne patients to seek treatment. If a lesion becomes severely inflamed it may leave a scar. Severe scarring caused by acne is associated with substantial physical and psychological distress, particularly in adolescents. This article reviews the causes of acne, the treatment options, and grading scales.