Safety and Efficacy of a 1550nm/1927nm Dual Wavelength Laser for the Treatment of Photodamaged Skin.

BACKGROUND: Fractional photothermolysis (FP) is a popular treatment option for photodamaged skin and addresses shortcomings of ablative skin resurfacing and nonablative dermal remodeling. Previous studies have demonstrated that FP using the 1550nm wavelength has led to improvement of ultrastructural changes and clinical effects associated with photodamaged skin in the deeper dermal structures, while treatment with the 1927nm wavelength has shown clinical effects in the superficial dermis. Both wavelengths produce precise microscopic treatment zones (MTZs) in the skin. The two wavelengths used in combination may optimize the delivery of fractional nonablative resurfacing intended for dermal and epidermal coagulation of photodamage skin.

OBJECTIVES: To evaluate the safety and efficacy of a 1550/1927 Laser System (Fraxel Dual, Solta), using both 1550nm and 1927nm wavelengths in combination for treatment of facial and non-facial photodamage.

METHODS: Prospective, multi-center, post-market study in subjects with clinically identifiable photodamage (N=35) (Fitzpatrick skin types I-IV). Both 1550nm and 1927nm wavelengths were used at each treatment visit. Investigator assessment of the affected area(s) occurred at one week, one month and 3 months after a series of up to four treatments. Severity of adverse events (AEs) were assessed using a 4-point scale (where 0=none and 3=marked). Assessments included erythema, edema, hyperkeratosis, hyper- and hypo-pigmentation, scarring, itchiness, dryness, and flaking. Severity of photoaging, fine and coarse wrinkling, mottled hyperpigmentation, sallowness, and tactile roughness at baseline was assessed using the same scale. Investigators and subjects assessed overall appearance of photodamage and pigmentation based on a 5-point quartile improvement scale at all follow-up visits (where 0=no improvement and 4=very significant improvement [76%-100%]).

RESULTS: There was a positive treatment effect at all study visits, with moderate improvement (average reduction in severity of 21%-43%) observed 3-months after final treatment. Greatest reduction in severity of other benefit areas was at the 3-month follow-up visit, with a 21% and 30% decrease in severity in fine wrinkling and tactile roughness. No AEs or serious AEs were reported. Pain sensation during treatment was tolerable. Anticipated moderate erythema (mean score 1.6±0.5) and mild edema (mean score 0.8±0.7) were transient and resolved within 7-10 days. Anticipated and transient mild dryness (52% of subjects) and flaking (30%) were reported at the 1-week follow-up. There were no incidences of hyperkeratosis, scarring, or itchiness.

CONCLUSION: Treatments using both wavelengths associated with the combined 1550/1927 Laser System were well tolerated with limited, transient anticipated side effects and no serious AEs. Clinical efficacy in the appearance of photodamage and pigmentation was greatest following a series of up to 3 treatments.

J Drugs Dermatol. 2018;17(1):41-46.

The Male Aesthetic Patient: Facial Anatomy, Concepts of Attractiveness, and Treatment Patterns.

BACKGROUND: The number of nonsurgical aesthetic procedures performed in men is growing rapidly. However, there are limited data on treatment principles and goals for the male aesthetic patient.

OBJECTIVE: To review the objective data available on male aging and aesthetics and to synthesize with expert opinion on treatment considerations specific to male patients.

METHODS: Expert advisors met to discuss anatomical differences in male versus female facial anatomy related to aging, facial treatment preferences in aesthetically oriented men, and current dosing data for facial injectable treatments in male versus female patients.

RESULTS: Symmetry, averageness, sexual dimorphism, and youthfulness are generally accepted as factors that contribute to the perception of attractiveness. There are differences between men and women in facial anatomy, concepts of attractiveness in the context of masculinity and femininity, and treatment objectives. A communication gap exists for men, as evidenced by the lack of information available online or by word of mouth about injectable treatments.

CONCLUSIONS: Approaches to aesthetic consultation and treatment should differ between men and women based on the fundamental dissimilarities between the sexes. Educating men about available aesthetic treatments and about the safety and side effects associated with each treatment, as well as addressing concerns about their treatment results looking natural, are key considerations.

J Drugs Dermatol. 2018;17(1):19-28.

Impact of Comprehensive, Minimally Invasive, Multimodal Aesthetic Treatment on Satisfaction With Facial Appearance: The HARMONY Study.

BACKGROUND: Individuals seeking aesthetic treatment have concerns regarding multiple facial areas. OBJECTIVES: Assess the aesthetic impact and satisfaction achieved with a multimodal approach to aesthetic treatment using a combination of minimally invasive treatments. METHODS: Prospective, multicenter, rater-blinded, 4-month HARMONY study evaluated patient satisfaction and aesthetic impact of a combination of fillers (VYC-20L, HYC-24L, and HYC-24L+), onabotulinumtoxinA, and bimatoprost. Males and females aged 35 to 65 years received on-label, staged treatment with fillers, as needed per investigator assessment, on day 1, with touch ups allowed on day 14. Bimatoprost was self-administered once daily for 17 weeks. OnabotulinumtoxinA was injected into glabellar lines, crow's feet lines, or both at month 3. Primary effectiveness measure was mean change from baseline on the FACE-Q 10-item Satisfaction with Facial Appearance Overall Scale. RESULTS: Of 100 patients treated, 93 underwent at least the 4-month posttreatment assessment and were assessed for efficacy. The FACE-Q Satisfaction with Facial Appearance Overall Scale total score increased from baseline (41.2) to month 4 (72.9; P < 0.00001; effect size, 2.7). Improvement following multimodal treatment was observed on FACE-Q individual items. Self-perceived age decreased from 0.2 years older than actual age at baseline to 4.6 years younger at month 4. Nearly all patients (99%) rated themselves as improved or much improved on the Global Aesthetic Improvement Scale. Investigator assessments also demonstrated improvement. Mild to moderate adverse events occurred in 42 patients. CONCLUSIONS: Minimally invasive, multimodal treatment resulted in improvements in FACE-Q scores and perceived age, indicating a high degree of patient satisfaction and a younger facial appearance.

A Comprehensive Approach to Multimodal Facial Aesthetic Treatment: Injection Techniques and Treatment Characteristics From the HARMONY Study.

BACKGROUND: The HARMONY study is the first clinical trial to assess the impact of a global approach to facial rejuvenation with several minimally invasive modalities, using patient-reported outcome measures. OBJECTIVE: Provide details of this treatment approach and describe investigators' experiences and recommendations based on this study. METHODS: This multicenter, 4-month study evaluated subject satisfaction with and psychological impact of combined treatment with VYC-20L (Juvéderm Voluma XC), HYC-24L (Juvéderm Ultra XC), HYC-24L+ (Juvéderm Ultra Plus XC), onabotulinumtoxinA (Botox), and bimatoprost 0.3% ophthalmic solution (Latisse). Treatment-naive adults with moderate-to-severe facial lines and folds and eyelash hypotrichosis received on-label, staged treatment with fillers. Bimatoprost was self-administered once daily for 17 weeks from day 1. OnabotulinumtoxinA was administered for glabellar lines, crow's feet lines, or both at month 3. RESULTS: Overall, 100 subjects received bimatoprost for eyelash hypotrichosis, 96 received onabotulinumtoxinA for glabellar lines and/or crow's feet lines, and 96 received VYC-20L for midface volume deficit. From 17 to 96 subjects received HYC-24L and/or HYC-24L+ for nasolabial folds, oral commissures, marionette lines, perioral lines, or radial cheek lines. Injections of filler generally progressed from cranial to caudal, with midface injected first. Investigator-reported factors that may have contributed to the potential benefits of this approach include the critical role of the midface in facial aesthetics, use of lower volumes of filler in individual facial areas, and anesthetic effects. CONCLUSION: The investigators' perspectives and experience with the injection pattern, sequencing, volumes, and techniques may provide valuable guidance for a multimodal approach to facial aesthetic treatment.

Rejuvenating Hydrator: Restoring Epidermal Hyaluronic Acid Homeostasis With Instant Benefits.

Skin aging is a combination of multifactorial mechanisms that are not fully understood. Intrinsic and extrinsic factors modulate skin aging, activating distinctive processes that share similar molecular pathways. One of the main characteristics of youthful skin is its large capacity to retain water, and this decreases significantly as we age. A key molecule involved in maintaining skin hydration is hyaluronic acid (HA). Concentration of HA in the skin is determined by the complex balance between its synthesis, deposition, association with cellular structures, and degradation. HA bio-equivalency and bio-compatibility have been fundamental in keeping this macromolecule as the favorite of the skincare industry for decades. Scientific evidence now shows that topically applied HA is unable to penetrate the skin and is rapidly degraded on the skin surface. SkinMedica's HA5 Rejuvenating Hydrator (SkinMedica Inc., an Allergan company, Irvine, CA) promotes restoration of endogenous epidermal HA homeostasis and provides instant smoothing and hydration of the skin. These dual benefits are accomplished through the combination of 2 breakthrough technologies: 1) a unique blend of actives powered by SkinMedica proprietary flower-derived stem cell extract that restores the endogenous production of HA; and 2) a proprietary mix of 5 HA forms that plump the skin, decreasing the appearance of fine lines/wrinkles. Pre-clinical studies demonstrated that HA5 induces expression of key epidermal differentiation and barrier markers as well as epidermal HA synthases. A decrease expression of hyaluronidases was also observed upon HA5 application. Initial clinical studies showed that within 15 minutes of application, HA5 instantly improves the appearance of fine lines/wrinkles and skin hydration. Subjects that continue using HA5 (for 8 weeks) demonstrated significant improvements in fine lines/wrinkles, tactile roughness, and skin hydration. In summary, the blend of these 2 key technologies present in HA5 promotes restoration of endogenous epidermal HA while delivering instant smoothing effects.

A Randomized, Blinded Study to Validate the Merz Hand Grading Scale for Use in Live Assessments.

BACKGROUND: The Merz Hand Grading Scale (MHGS) is a 5-point scale used to grade appearance of the dorsum of the hand. The MHGS has been previously validated for assessment of photographed hands but not for live assessment. OBJECTIVE: The purpose of this randomized, blinded study was to validate the MHGS for live assessment of the hands in the clinical setting. METHODS: Three physician raters completed a scale qualification program that included MHGS training, ratings of standardized hand photographs, and statistical analysis for reliability. Eighty-four subjects (28 males, 30% Fitzpatrick skin Types IV-VI, mean age of 42 years), randomized to 2 live assessment sessions for independent and blinded observation of dorsa of their right hands, completed the study. RESULTS: Overall MHGS intrarater weighted Kappa value was 0.74 (0.68-0.79 [CI 95%]). First- and second-time hand-rating agreement scores ranged from 64% to 75%. Interrater weighed Kappa values ranged from 0.59 to 0.71, representing between-rater paired results of each combination of raters. CONCLUSION: High-weighted Kappa values and agreements demonstrate that consistency at different time points can be achieved individually and by different raters for live assessments. The MHGS is a suitable instrument for live assessment in the clinical setting.

High-intensity focused ultrasound for the reduction of subcutaneous adipose tissue using multiple treatment techniques.

BACKGROUND: High-intensity focused ultrasound (HIFU) is a noninvasive alternative to traditional invasive body sculpting procedures. OBJECTIVE: To assess the effectiveness and tolerability of HIFU treatment using high and low fluence settings with 2 treatment techniques, grid repeat (GR) and site repeat (SR). MATERIALS AND METHODS: Two multicenter studies were conducted. Subjects underwent 1 HIFU treatment with 1 of 5 treatment protocols (total fluence, 150-180 J/cm). Primary end point was change from baseline in waist circumference (CBWC) at 12 weeks. Secondary end points included CBWC at 4 and 8 weeks and investigator- and subject-assessed clinical improvement. Adverse events were monitored throughout the study. RESULTS: In the intent-to-treat (ITT) population, all subjects had a statistically significant mean circumferential reduction of -2.3 ± 2.9 cm (p < .0001) from baseline at 12 weeks, with no significant differences among the 5 treatment groups (ITT: p = .153). Analysis of secondary end points in the ITT population demonstrated a significant circumferential reduction starting as early as 4 weeks in all subjects (-1.1 ± 1.9 cm, p < .0001). Most subjects in all treatment groups showed improvements at 12 weeks as rated by the investigators and subjects. CONCLUSION: High-intensity focused ultrasound treatment using either a low or high fluence setting in a GR or SR method is effective for circumferential waist reduction, resulting in statistically significant CBWC in all treatment groups.

The role of calcium hydroxylapatite (Radiesse) in nonsurgical aesthetic rejuvenation.

Radiesse (Bioform Medical, San Mateo, CA) is a synthetic calcium hydroxylapatite microsphere filler suspended in an aqueous carrier gel. Radiesse currently has indications in the United States (U.S.) for the correction of signs of lipoatrophy in individuals with human immunodeficiency virus (HIV) as well as for the correction of moderate-to-deep nasolabial folds. There are also numerous off label reports in the literature of use in other facial aesthetic procedures. This review describes the composition of calcium hydroxylapatite, its mechanism of action, durability and safety, pre- and post-procedure care, injection techniques, appropriate use, concomitant anesthesia, as well as potential adverse events and complications.

An open-label trial examining the efficacy and safety of a pre- and postprocedure topical five-product system (Clinique Medical Optimizing Regimen) specifically formulated to complement laser/light-based facial cosmetic procedures.

BACKGROUND: Specialized skin care regimens may help to minimize adverse events (AEs) following non-ablative facial procedures. METHODS: A 14-week, open-label, three-center study evaluated the efficacy and safety of a topical five-product system (Clinique Medical Optimizing Regimen; Allergan, Inc., Irvine, CA, USA) for minimizing localized AEs during two 6-week procedure cycles with fractionated laser (FL) or intense pulsed light (IPL). The skin care regimen consisted of a 2-week preprocedure phase, a 1-week postprocedure phase, and a 3-week maintenance phase. Investigators and patients rated the presence and severity of erythema, itching, stinging/burning, edema, pain, pruritus, swelling, crusts/erosion, and photodamage. RESULTS: Two days after the FL/IPL treatment (IPL: n = 27; FL: n = 21), most assessments, including erythema, were near baseline values; at 4 weeks postprocedure, all investigator scores were comparable to baseline. Patients missed work or avoided social situations a mean of only 0.8 days. Mean subject ratings for itching, stinging/burning, pain, swelling, and redness for 2 weeks postprocedure were 'none' to 'mild'. Treatment-related AEs (acne, facial rash) occurred in four patients. All investigators stated they would recommend this topical over-the-counter regimen again in conjunction with non-ablative FL/IPL treatments. CONCLUSIONS: This topical five-product skin care system was safe and effective in conjunction with non-ablative FL/IPL procedures.

Nonablative fractional resurfacing in the male patient.

Skin resurfacing can be divided into nonablative, nonablative fractional, ablative fractional, and traditional ablative categories. Nonablative technologies have yielded inconsistent and unimpressive results, whereas ablative technologies, although generally clinically effective, are losing momentum as a result of prolonged recovery times, risks for hypopigmentation, limitation in lighter skin types, and the production of unnatural sheen and texture to the skin. Fractional resurfacing can produce the safety of nonablative technologies and the efficacy of traditional ablative resurfacing. Nonablative fractional resurfacing is the most widely studied of fractional technologies allowing for nonablative tissue coagulation, creation of microthermal zones, and resurfacing with extrusion and replacement of damaged tissue with rapid re-epithelialization. This article will review nonablative fractional resurfacing with 1550-nm laser in the male patient.

A Split-Face Evaluation to Assess the Efficacy of a Hydrolyzed Roe Cream in the Reduction of Erythema Following Chemical Peel.

Objective:To evaluate a hydrolyzed roe cream in the reduction of facial erythema following a chemical peel treatment. Edema was also assessed. Design:The facial cream was applied to one side of the face of 30 healthy female subjects (average age = 54.9 years, range 33-65 years) immediately following 4 to 15 minutes peel treatment. The opposite side remained untreated. Visia-CR digital photographs were taken at baseline and 8 and 24 hours post facial peel. Objective dermal irritation assessments were done by a blinded investigator, graded on severity of facial erythema and edema on a 5-point scoring scale; 0=none, 1 =slight,2=mild, 3=moderate, 4=severe. Subjects completed a perception questionnaire. Results: Reduction in erythema was greater (P≤0.05) for the treated side of the face compared to the untreated side at both 8 and 24 hours post-peel. Both sides showed reduction in erythema compared to immediate post-peel. No edema was observed. At eight hours, more than 50 percent of subjects agreed on the five attributes, and at 24 hours, 57 percent (17/30) of subjects agreed. At eight hours, ≥80 percent of subjects strongly agreed or agreed that the treated skin feels hydrated and moisturized immediately after application. At 24 hours, more than 90 percent of subjects strongly agreed or agreed that treated skin feels perfectly hydrated and moisturized. When asked about their overall impression of the product, 60 percent (18 subjects) of subjects responded"! love it."All subjects completed the study. No adverse events were reported. Conclusion: Applying the facial lotion directly on post-procedure skin reduces redness after 8 and 24 hours significantly better compared to no treatment.

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.

Nonablative fractional laser resurfacing.

Nonablative fractional resurfacing (NFR) uses a mode of delivery with preservation of the stratum corneum, a true resurfacing with epidermal extrusion, and creation of microscopic thermal zones of injury that ultimately lead to neocollagenesis. This article discussed the science, clinical indications, patient selection and preparation, posttreatment care, and complications of NFR. It concludes that the most impressive clinical results are seen with acne scars, surgical and traumatic scars, and mild to moderate facial and nonfacial dyschromia or photoaging. Modest results can be seen with therapy-resistant melasma and certain types of rhytides. Future approaches include synergistic treatments with radiofrequency devices and the development of novel wavelengths to enhance the efficacy of NFR while preserving safety.

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.

Skin rejuvenation with microthermal fractional photothermolysis.

Fractional resurfacing is gaining acceptance as a preferred method for skin resurfacing. Experience in treating photoaging, acne scars, and melasma is reviewed.