Development and validation of the Axillary Sweating Daily Diary: a patient-reported outcome measure to assess axillary sweating severity.

BACKGROUND: Hyperhidrosis is estimated to affect ~ 4.8% of the US population, and most patients experience a negative psychological impact. Here, we describe development and psychometric evaluation of a patient-reported outcome (PRO) measure to assess severity of axillary hyperhidrosis in clinical trials that meets current U.S. regulatory standards to support product approvals. METHODS: Three rounds of hybrid concept-elicitation/cognitive-debriefing qualitative interviews were conducted in adults with clinician-diagnosed primary axillary hyperhidrosis, followed by similar interviews in children/adolescents. The draft measure included diary items for presence, severity, impact and bothersomeness (basis of the Axillary Sweating Daily Diary [ASDD]), exploratory weekly impact items, and a single-item Patient Global Impression of Change (PGIC). Phase 2 (adults only) and phase 3 (adults and children ≥9 years) clinical trial data were utilized to evaluate measurement properties of the resulting draft measure: floor/ceiling effects, nonresponse bias, test-retest reliability, construct validity, and responsiveness were assessed. The primary concept of interest was axillary sweating severity (ASDD Item 2); however, additional supportive concepts were explored to allow for development of a comprehensive hyperhidrosis measure. RESULTS: Twenty-nine patient interviews were conducted (N = 21 adult and N = 8 children/adolescents), resulting in the ASDD (4 items, patients ≥16y) and child-specific ASDD-C (2 items ≥9y to <16y), as well as 6 Weekly Impact items and the PGIC (patients ≥16y). No floor/ceiling effects or response biases were identified. Consistency between hypothesized and observed correlation patterns between ASDD/ASDD-C items and other efficacy measures supported construct validity. Intraclass correlation coefficients supported test-retest reliability (0.91-0.93; Item 2). Large effect sizes (- 2.2 to - 2.4) demonstrated that the ASDD/ASDD-C Item 2 could detect changes in hyperhidrosis severity, supporting the measure's responsiveness. Patients perceiving a moderate improvement in symptoms on the PGIC experienced an average 3.8-point improvement on ASDD axillary sweating severity (Item 2); thus, a 4-point responder threshold was defined as a clinically meaningful change. CONCLUSIONS: Qualitative and quantitative evidence support the reliability and validity of the ASDD/ASDD-C and its use in the clinical evaluation of axillary hyperhidrosis treatments. Further evaluation of this measure in future research studies is warranted to demonstrate consistent performance across different axillary hyperhidrosis populations and in different study contexts.

Long-term safety and efficacy of bimatoprost solution 0·03% application to the eyelid margin for the treatment of idiopathic and chemotherapy-induced eyelash hypotrichosis: a randomized controlled trial.

BACKGROUND: Bimatoprost ophthalmic solution 0·03% is approved in several countries for the treatment of eyelash hypotrichosis. Previous trials were limited to 4 months of treatment and primarily idiopathic hypotrichosis. OBJECTIVES: To evaluate the long-term safety and efficacy of bimatoprost in patients with idiopathic or chemotherapy-induced hypotrichosis. METHODS: This multicentre, double-masked, randomized, parallel-group study included two 6-month treatment periods [treatment period 1 (TP1) and treatment period 2 (TP2)]. Patients with idiopathic hypotrichosis were randomized to three treatment groups: (i) bimatoprost (TP1 and TP2); (ii) bimatoprost (TP1) and vehicle (TP2); and (iii) vehicle (TP1) and bimatoprost (TP2). Patients with chemotherapy-induced hypotrichosis were randomized to two treatment groups: (i) bimatoprost or vehicle (TP1) and (ii) bimatoprost (TP2). Primary end point was a composite of at least a one-grade improvement in investigator-assessed Global Eyelash Assessment and at least a three-point improvement in patient-reported Eyelash Satisfaction Questionnaire Domain 2 at month 4. Secondary measures included digitally assessed eyelash characteristics. RESULTS: The primary efficacy end point was met in both populations (idiopathic responder rate was 40·2% for bimatoprost vs. 6·8% for vehicle; postchemotherapy responder rate was 37·5% for bimatoprost vs. 18·2% for vehicle). Efficacy by month 6 was maintained (idiopathic) or enhanced (postchemotherapy) at 12 months. Treatment effects were maintained for approximately 2 months but markedly diminished 4-6 months following treatment cessation in patients with idiopathic hypotrichosis. No drug-related serious adverse events were reported. CONCLUSIONS: Daily treatment with bimatoprost ophthalmic solution 0·03% for 1 year was effective and well tolerated in patients with idiopathic and chemotherapy-induced hypotrichosis.

The use of botulinum toxins to treat hyperhidrosis and gustatory sweating syndrome.

Hyperhidrosis is a chronic condition characterized by excessive sweating. Recent studies report that it affects approximately 2.8% of the population and typically begins during adolescence. Gustatory sweating usually occurs after parotid gland injury or surgery, and both disorders can be debilitating for those who are affected. Both diseases respond very well to botulinum toxin therapy and this article will review the use of botulinum toxins, including the serotypes used, dosing, and complications.

The influence of cortical feature maps on the encoding of the orientation of a short line.

The inhomogeneous distribution of the receptive fields of cortical neurons influences the cortical representation of the orientation of short lines seen in visual images. We construct a model of the response of populations of neurons in the human primary visual cortex by combining realistic response properties of individual neurons and cortical maps of orientation and location preferences. The encoding error, which characterizes the difference between the parameters of a visual stimulus and their cortical representation, is calculated using Fisher information as the square root of the variance of a statistically efficient estimator. The error of encoding orientation varies considerably with the location and orientation of the short line stimulus as modulated by the underlying orientation preference map. The average encoding error depends only weakly on the structure of the orientation preference map and is much smaller than the human error of estimating orientation measured psychophysically. From this comparison we conclude that the actual mechanism of orientation perception does not make efficient use of all the information available in the neuronal responses and that it is the decoding of visual information from neuronal responses that limits psychophysical performance.

Illusory motion in Enigma: a psychophysical investigation.

Experiments to determine the optimum conditions for perceiving illusory motion in Engima-like patterns have also demonstrated that the illusory motion is not the result of unintended motion of the image on the retina due to microsaccades or accommodative changes in the lens of the eye but instead has a cortical origin. The perceived illusory activity is believed to be a consequence of neural signals emanating from high-contrast bars and edges in the image that emit randomly fluctuating signals, as expected from spiking cortical neurons. These fluctuations may induce illusory motion in the channels by a mechanism similar to that responsible for the Omega effect, in which sequences of random patterns of black dots presented in an annular channel produce the perception of illusory rotation of these dots within the annulus.

Effect of botulinum toxin pretreatment on laser resurfacing results: a prospective, randomized, blinded trial.

BACKGROUND: Facial laser resurfacing and chemodenervation with botulinum toxin type A are used independently as means of nonsurgical facial rejuvenation. Recent reports in the literature have described combining these 2 therapies, claiming improved and longer-lasting laser resurfacing results. To date, no scientific investigation has been undertaken to prove or disprove this theory. DESIGN: Institutional review board-approved, prospective, randomized, blinded study at university-affiliated outpatient cosmetic surgery offices. INTERVENTION: Patients had one side of their face injected, at specific anatomic subsites (crow's feet, horizontal forehead furrows, and glabellar frown lines), with botulinum toxin 1 week before laser resurfacing. After receiving an injection, patients underwent cutaneous laser exfoliation on both sides of the face with either a carbon dioxide or an erbium dual-mode laser. MAIN OUTCOME MEASURES: Patients' injected (experimental) and noninjected (control) sides were compared after laser resurfacing. Follow-up was documented at 6 weeks, 3 months, and 6 months after laser resurfacing. Subjective evaluation, based on a visual analog scale, was performed in person by a blinded observer. Furthermore, a blinded panel of 3 expert judges (1 facial plastic surgeon, 1 oculoplastic surgeon, and 1 cosmetic dermatologist) graded 35-mm photographs taken during postoperative follow-up visits. RESULTS: Ten female patients were enrolled in the study. A 2-tailed t test showed that all sites that were pretreated with botulinum toxin showed statistically significant improvement (P< or =.05) over the nontreated side, with the crow's feet region showing the greatest improvement. Comparing results between the carbon dioxide and erbium lasers did not result in any statistically significant differences. CONCLUSIONS: Hyperdynamic facial lines, pretreated with botulinum toxin before laser resurfacing, heal in a smoother rhytid-diminished fashion. These results were clinically most significant in the crow's feet region. We recommend pretreatment of movement-associated rhytides with botulinum toxin before laser resurfacing. For optimum results, we further recommend continued maintenance therapy with botulinum toxin postoperatively.

Topical and systemic therapies for the aging face.

Many cosmeseuticals and drugs are available to treat and augment therapy for the aging face. Patients frequently have misconceptions about the use of these agents, and it is important that today's cosmetic surgeon know how to maximize the benefits while minimizing side effects. The role of retinoids, antioxidants, hydroxy acids, bleaching agents, moisturizers, and sunscreens are reviewed as they relate to skin rejuvenation.

Skin resurfacing with the erbium:YAG laser.

The Er:YAG laser provides superficial ablation and is generally used for more superficial rejuvenation. Three newer systems provide for thermal-coagulative and ablative properties. These systems are considered as intermediate resurfacing lasers, providing faster healing and results that are typically in between those of the CO2 and standard Er:YAG lasers. The use of traditional and combination Er:YAG lasers is reviewed along with preoperative and postoperative considerations.

Disseminated superficial actinic porokeratosis associated with topical PUVA.

Disseminated superficial actinic porokeratosis (DSAP) is associated with sun exposure and tanning bed usage and has been rarely reported in association with systemic PUVA. We report the first case of DSAP occurring after topical foot PUVA.

Treatment of pseudofolliculitis barbae using the Q-switched Nd:YAG laser with topical carbon suspension.

BACKGROUND: Pseudofolliculitis barbae (PFB) is a condition caused by ingrown hairs of the face. No treatment to date has shown long-term effectiveness without risk of side effects or ease of treatment. OBJECTIVE: The goal of this pilot study was to evaluate the use of the topical suspension-assisted Q-switched Nd:YAG laser in the treatment of PFB. METHODS: Nine patients were given two treatments 1 month apart and assessed by objective papule/pustule counts at 1 and 2 months after final treatment. Treatment sites were 9 cm2 regions on the mandible and neck, with contralateral controls. Patients also performed subjective evaluations. RESULTS: Reduction in the quantity of papules and pustules when compared with baseline was statistically significant for treatment of the mandibular region and combined sites at 1- and 2-month evaluations, as well as the neck region at the 2-month evaluation. CONCLUSION: Use of the Q-switched Nd:YAG laser with topical carbon suspension is an effective means of treating PFB, with results persisting at least 2 months after treatment.

Hair removal using topical suspension-assisted Q-switched Nd:YAG and long-pulsed alexandrite lasers: A comparative study.

BACKGROUND: The use of lasers for removal of unwanted hair has been shown to be effective in temporarily controlling hair growth. Several lasers are currently utilized for this purpose. OBJECTIVE: This study evaluates the short-term effectiveness and discomfort levels of the long-pulsed alexandrite laser and the topical suspension-assisted Q-switched Nd:YAG laser in a side-by-side comparison. METHODS: Fifteen subjects were treated in the bilateral hair-bearing axilla, using one treatment with the alexandrite laser for the right and two treatments with the topical suspension-assisted Nd:YAG laser for the left. Reduction in hair regrowth was measured at 2 and 3 months following the first treatment by comparing the terminal hair count to the baseline values. Patients rated their pain on a scale of 0-10 immediately following the first treatment at each site. RESULTS: The mean percentage reduction in hair regrowth 2 months following alexandrite laser treatment was 55% and 73% for the Nd:YAG laser-treated regions. After 3 months, alexandrite laser-treated patients showed a reduction of 19%, while Nd:YAG laser-treated patients showed a 27% reduction. Patients reported average pain values of 8 and 4 for the long-pulsed alexandrite and Nd:YAG laser sites, respectively. All differences were significant. CONCLUSION: While the design of this study makes it difficult to compare the relative effectiveness of the lasers, both systems evaluated were shown to delay hair growth and provide patients with a satisfactory treatment.

Cimetidine therapy for recalcitrant warts in adults: is it any better than placebo?

Three open-label, uncontrolled studies have documented successful treatment of warts with cimetidine, whereas two placebo-controlled, double-blind studies and two open-label comparative trials have failed to demonstrate efficacy. This double-blind, placebo-controlled study was designed with stringent enrollment and outcome criteria to minimize the confounding issue of spontaneous remission. Efficacy was not statistically superior to that of placebo, but a trend toward efficacy was suggested for younger subjects.

The incidence of cancellation and nonattendance at a dermatology clinic.

BACKGROUND: Same-day cancellation of appointments and nonattendance by patients can disrupt management of certain aspects of medical delivery and lead to inefficient allocation of resources and lost revenue. The frequency of cancellation and nonattendance at dermatology clinics has not been well documented. OBJECTIVE: We measured same-day cancellation and nonattendance in a university dermatology clinic. METHODS: We tabulated clinic attendees, same-day cancellations, and nonattendance for a 6-month period. We examined distribution by gender, type of payer, and clinic visit type (initial or follow-up). RESULTS: Total same-day cancellation rate was 8.3%. Female patients canceled more frequently than male patients (9.2% vs 7.3%, P = .02). Cancellation rates were similar for initial and follow-up visits. The nonattendance rate was 17% with the highest rates found in state-supported categories (26%) and the lowest in commercial insurance programs (13%). Nonattendance rates did not vary significantly by gender or visit type. CONCLUSION: Same-day cancellation and clinic nonattendance is a significant factor in the efficient fiscally sound management of a busy dermatology clinic. The risk of nonattendance is assumed by physicians and seems to be correlated with payer type.