Beyond health-related quality of life: initial psychometric validation of a new scale for addressing the gap in assessing the full range of alopecia areata psychosocial burden.

BACKGROUND: Patients with alopecia areata (AA) report a broad range of psychosocial outcomes beyond those assessed in existing health-related quality of life measures. Yet, to date, no psychometrically validated scale based on patient-reported outcomes (PROs) appears to exist to comprehensively measure these AA-specific psychosocial outcomes. OBJECTIVES: The objective of this study was to develop such a scale, the Scale of Alopecia Areata Distress (SAAD), and to provide its initial validation evidence. METHODS: Using existing qualitative research on PROs for patients with AA, a pool of 144 items was generated and subsequently reviewed for relevance, redundancy, clarity and comprehensiveness by subject matter experts in AA psychosocial impacts and the research team. This review resulted in a reduced pool of 122 items, which was then administered to adult patients with AA residing in the USA. Exploratory Factor Analysis using Principal Axis Factoring extraction with oblique rotation identified the SAAD's underlying factor structure. To reduce the SAAD item length, additional item-reduction strategies were used. RESULTS: There were 392 participants who responded to the 122 items, each with four or fewer missing item responses. Three iterations of the data analysis plan resulted in a 41-item SAAD with seven underlying factors of psychosocial impact: Emotional and Cognitive Functioning, Romantic Relationships, Family Relationships, Primary Life Responsibilities, Non-Primary Life Responsibility Activities, Stigma, and Self-Perception Change. Each factor demonstrated acceptable to high levels of internal consistency reliability. CONCLUSIONS: Initial validation evidence of the SAAD-41 scale supports its potential as a comprehensive measure of AA-related psychosocial distress for US-based adults. Further scale validation is needed.

Comparative Study of Professional vs Mass Market Topical Products for Treatment of Facial Photodamage.

BACKGROUND: Many over the counter topical products claim to reverse the signs of cutaneous photo-damage. To date, the two most studied ingredients for improving the texture, tone, and pigmentation of the skin are topical retinoids and hydroquinone. OBJECTIVE: This split face study compares a mass market skincare regimen with a prescription skin care regimen for improvement in photo damaged skin. METHODS: Twenty-seven subjects with moderate photo damaged facial skin were enrolled. Each subject was consented and assigned with the mass market anti-aging system (Treatment A) to one side of the face and the prescription anti-aging system (Treatment B or Treatment C) to the other side of the face. Treatment B contained 13 subjects whom did not use 0.025% Retinol cream. Treatment C contained 14 subjects who used a 0.025% Retinol Cream. Subjects had 4 visits over 12 weeks for digital photography and surveys. Photographs were evaluated by blinded physicians. RESULTS: Physician objective analysis showed all three systems to have a statistically significant clinical improvement in photoaged skin seen in as little as 4 weeks of use. Participant's surveys rated the mass market system higher than both of the professional systems for visible skin changes, ease of use, and likelihood to recommend to a friend. Twelve of twenty-seven subjects preferred the mass market system for overall improvement while twelve thought each system gave the same improvement. CONCLUSION: This study demonstrates that a mass marketed skin care system can give similar clinical improvements in photo-aged skin as a professionally dispensed prescription system and the majority of participants preferred the mass-marketed system.

Treatment of Facial Photodamage With Mass Market Topical Products vs Non-ablative Fractional Laser.

METHODS: In this split-face, evaluator-blinded study, 18 subjects were randomly assigned to receive either the SSR or NFL treatments on each side of the face. For the SSR facial sides subjects followed two morning-evening regimens. On the NFL sides subjects were treated 3 times with the 1927-nm laser at 4-week intervals. Three physician evaluators were asked to rate hyperpigmentation, global photoaging, and ne lines and wrinkles for each side of the face at baseline and at 3 months using a 5-point scale. RESULTS: The SSR and NFL treatments provided comparable results for each skin attribute. Improvement from baseline was signi - cant in both treatment programs for each skin attribute. The greatest 3-month improvement for both programs was in hyperpigmen- tation. For global photoaging and ne lines and wrinkles, positive responses were slightly greater in the NFL than in the SSR facial sides. Subject preference for the SSR over the NFL was greatest for ne lines around the eyes, ne lines around the mouth, smooth texture, radiant complexion, and overall improvement while the NFL was preferred for skin rmness and evenness. When the study was completed5 of 18 split-face subjects decided to undergo NFR laser treatment on the non laser treated side along with using the SSR product and 13 of the 18 subjects continued to use the SSR products to their full face after the study. CONCLUSION: The mass market skin care system of the present study provides improvement in hyperpigmentation, global photoaging, and ne lines and wrinkles comparable to that of a series of treatments with a non-ablative fractional laser. J Drugs Dermatol. 2016;15(11):1366-1372..

Evaluation of a novel home skin care platform.

The home beauty device market is rapidly growing, having more than tripled in the last four years. This study evaluates several specific attachment heads using a novel home skincare platform (HSP). By incorporating multiple treatment heads for cleansing, skin smoothing, and skin infusion, this device has the potential to address many potential treatment goals. The first subset of this study is a blinded, randomized split-face study evaluating the efficacy of the HSP device with a standard brush head for make-up removal and compares the HSP device to a currently marketed home cleansing device. The results show that the HSP cleansing head was comparable to the leading home skin cleansing device on the market. The HSP's skin smoothing head showed statistically significant improvement in erythema and dryness over baseline levels with significant histologic changes including normalization of epidermal thickness in only 10 days of use. This is comparable to and exceeds many well-studied antiaging treatments after weeks and months of therapy. Finally, the infusion head demonstrated improvement in skin hydration over baseline levels.

A randomized comparison of the efficacy of low volume deep placement cheek injection vs. mid- to deep dermal nasolabial fold injection technique for the correction of nasolabial folds.

BACKGROUND: Hyaluronic acid (HA) fillers are FDA approved for improving the appearance of the nasolabial folds. Previous reports on the use of HA for this treatment have focused on injections directly into the location of the desired correction. To our knowledge, a study has not been done evaluating the efficacy of injecting a low volume of HA into the adjacent area of volume loss to correct both volume loss and adjacent lines. OBJECTIVE: The objective of this study was to compare the effectiveness and safety of three HA injection protocols including deep dermal cheek injection, mid- to deep dermal local nasolabial fold injection, and both injections for the correction of nasolabial folds. METHODS: This was a split-face, randomized study evaluating the use of three injection techniques - (i) deep bolus injection into the mid- to lateral cheek, (ii) local mid- to deep dermal injection into the nasolabial fold, and (iii) both deep injection into the mid- to lateral cheek and local mid- to deep dermal injection into the nasolabial fold - for the treatment of moderate to severe nasolabial folds. Wrinkle severity and Global Aesthetic Improvement Scales were measured before and 4-6 weeks after treatment as assessed by a blinded investigator. RESULTS: Patient and physician observations showed improvement both globally and in wrinkle severity score with each technique used with no statistical difference between techniques. Patients showed a slight preference for injection to both the mid- to lateral cheek and nasolabial fold, which was associated with the greatest amount of filler product administered. No serious adverse events were reported. CONCLUSION: Injection of a dermal filler, at low volumes, into either the nasolabial fold or mid- to lateral cheek results in similar improvement to the correction of the nasolabial folds.

Survey of regional laser centers: a Minnesota perspective.

BACKGROUND: Laser use in medicine is rapidly expanding as patients seek treatment for medical and cosmetic purposes. Concern is mounting about the unsupervised use of lasers and similar devices by nonphysician personnel. Minnesota is currently one of the few states with no legislation regarding the uses of lasers. OBJECTIVE: To determine whether laser centers in Minnesota meet professional standards and guidelines for patient safety. METHODS AND MATERIALS: Public resources were used to identify all businesses with laser services in Minnesota cities with a population of at least 1,000 people. Each laser center was contacted, and a "secret shopper," a person who posed as a potential patient administered a telephone survey. RESULTS: A wide range of physicians and nonphysician personnel offer laser services in Minnesota. Supervision was not standardized and varied widely across the laser centers. CONCLUSIONS: As the demand for laser services increases, the use of lasers must be clearly defined and regulated to prevent patient injury. The authors have indicated no significant interest with commercial supporters.

Histologic analysis of a 2,940 nm fractional device.

BACKGROUND AND OBJECTIVES: An evaluation of the histological effects of a 2,940 nm fractional erbium:YAG (Er:YAG) laser device with adjustable depth and coagulation settings in a human abdominoplasty model. The goal of this study was to use light and confocal microscopy to determine the dimensions of the microthermal zones (MTZs) created by this device in the epidermal and dermal layers. STUDY DESIGN/MATERIALS AND METHODS: Three subjects were consented and treated after being randomly assigned to a laser depth of either 250 µm, 500 µm, or 1,000 µm. Four coagulation levels were tested in each subject. Two biopsies were taken immediately, 1 and 2 weeks post-treatment from each zone and viewed by light and confocal microscopy. Two blinded observers examined the sections for changes in collagen and measured depth and width of the MTZs. Coagulation was assessed and recorded as the depth and width of denaturation; measured as the depth and width of ablation plus surrounding thickness of thermal necrosis from dissipated heat. RESULTS: Light microscopy findings in all treated samples showed a perforated epidermis and dermis immediately after treatment. The depths of ablation produced did not accurately reflect the three different laser settings. Depths of denaturation also did not increase with increased coagulation level settings as expected. The width of ablation in the MTZs, a non-adjustable setting, was the most accurate and reproducible in all subjects. Confocal microscopy samples revealed the presence of collagen remodeling in the dermis, which increased significantly at 1 and 2 weeks post-treatment. CONCLUSIONS: Treatment with the 2,940 nm Er:YAG device led to significant changes of the dermis at light microscopy levels. The adjustable laser depth and coagulation settings did not produce predictable depths of ablation or denaturation, possibly as a result of the variation of tissue hydration properties among individuals. Increased collagen remodeling was seen in the dermis in all subjects at 1 and 2 weeks post-treatment.

Efficacy of a multiple diode laser system for body contouring.

BACKGROUND AND OBJECTIVES: Low-level laser therapy (LLLT) has been shown to induce cellular reactions in nonphotosynthetic cells however skepticism remains regarding efficacy at the clinical level. The purpose of this study was to evaluate the efficacy of LLLT independent of liposuction. Additionally, a weight loss supplement (Curva™, Santa Barbra Medical Innovations, Santa Barbra, CA) was evaluated. This clinical trial evaluates the effectiveness of the Erchonia EML Laser (Zerona™ System, Santa Barbra Medical Innovations) for non-invasive fat reduction and body contouring in a split-body clinical evaluation. MATERIALS AND METHODS: Five subjects were enrolled and completed the study. Subjects had a body mass index (BMI) of less than or equal to 29 kg/m(2) and satisfied the set inclusion criteria. Participants were randomly assigned to receive low-level laser treatments on one side of the body three times per week for 2 weeks. One group took the weight loss supplement and was also treated with the laser. Subject satisfaction questionnaires, physician blinded photo evaluation, circumference measurements and ultrasound measurements were utilized to evaluate efficacy. RESULTS: Circumference measurements revealed no statistically significant reduction at either 7 days or 1 month post-treatment. One month following treatment the greatest circumference reduction overall was 0.5 ± 0.3 inches. Ultrasound measurements also did not reveal statistically significant reduction in fat layer thickness (P > 0.5). Evaluation by three blinded dermatologists resulted in average correct photo identification of 51.1%. Results reflect little clinical difference between post-treatment and baseline images. Three subjects recording a "dissatisfied" rating on satisfaction questionnaires and all subjects reported the effects of the treatment were less than expected. Subjects who took the weight loss supplement had no greater circumference reduction or identifiable clinical outcome. CONCLUSIONS: This small study demonstrates to the authors that there needs to be more evidence to show clinical circumferential reduction before LLLT can be recommended as an effective therapeutic option.

Clinical study to determine the safety and efficacy of a low-energy, pulsed light device for home use hair removal.

BACKGROUND AND OBJECTIVES: The principle of selective photo-thermolysis has been studied extensively for hair removal applications in a medical setting. A new, portable, hand-held device featuring two filtered Xenon lamps that utilizes pulsed light in low optical fluencies for hair removal has been developed for consumer use. The purpose of this clinical study was to determine the efficacy and safety of this low-energy, pulsed-intense light device intended for home use hair removal. STUDY DESIGN/ MATERIALS AND METHODS: The treatment group consisted of 10 adults with skin types I-IV who possessed unwanted dark hair in the non-facial region. The subjects received between 4 and 6 treatments on a bi-weekly basis with the device by a trained member of the clinical staff. The clinical responses were evaluated by performing manual hair counts using magnified vision and photographs which were obtained prior to treatment and at each subsequent visit. RESULTS: Mean hair reduction was 36% 4 weeks after the final treatment and 10% 12 weeks after the final treatment. This resulted in a mean hair count reduction of 23% over the two follow-up appointments. There was no definitive correlation between customer satisfaction and hair count reduction. Adverse reactions were limited to transient, localized, post-treatment erythema. No complications were encountered. CONCLUSIONS: This low-energy, pulsed-light device is a quick, safe, and relatively effective at-home hair reduction treatment option in patients with various skin phototypes.