An Open Label Clinical Trial to Evaluate the Efficacy and Tolerance of a Retinol and Vitamin C Facial Regimen in Women With Mild-to-Moderate Hyperpigmentation and Photodamaged Facial Skin.

A 12-week open-label, single-center clinical usage trial was conducted to determine the effectiveness of a dual product regimen consisting of a 0.5% retinol treatment and an anti-aging moisturizer with 30% vitamin C in women with mild to moderate hyperpigmented and photodamaged facial skin. Clinical grading of several efficacy parameters, tolerability evaluations, subject self-assessment questionnaires, and digital photography were completed at baseline and at weeks 4, 8, and 12. A total of 44 women completed the study. Effective ingredients incorporated into the 0.5% retinol treatment included encapsulated retinol for a retinol concentration of 0.5%, bakuchiol, and Ophiopogon japonicus root extract. The anti-aging moisturizer with 30% vitamin C contained 30% vitamin C in the form of tetrahexyldecyl ascorbate (THD ascorbate), alpha-tocopheryl acetate (vitamin E) and ubiquinone (coenzyme Q10). The facial regimen produced a statistically significant decrease (improvement) in clinical grading scores for all parameters assessed at weeks 8 and 12 when compared with baseline scores. In addition, the majority of these parameters were improved at week 4. The test regimen was well-perceived by the subjects for various inquiries regarding facial skin condition, product efficacy, and product attributes. Several tolerability parameters were assessed with no statistically significant increase except for dryness. A statistically significant increase in clinical grading scores for dryness on the face occurred at weeks 4 and 8 when compared to baseline scores. The increase in dryness is expected when introducing a retinol product to a facial regimen and the dryness did not persist to the week 12 time point.

An Open Label Clinical Trial of a Multi-Ingredient Anti-Aging Moisturizer Designed to Improve the Appearance of Facial Skin.

An open label clinical trial was conducted to determine the effectiveness of a multi-ingredient anti-aging moisturizer designed to improve the appearance of facial skin. Parameters studied included fine lines and wrinkles, clarity/brightness, visual roughness, tactile roughness, evenness of skin tone (redness), evenness of skin tone (hyperpigmentation) and overall appearance. Thirty-seven female subjects, ages 35-60 years completed the study. Effective ingredients incorporated into the facial anti-aging moisturizer include: Astragalus membranaceus root extract, a peptide blend including palmitoyl tripeptide-38, standardized rosemary leaf extract (ursolic acid), tetrahexyldecyl ascorbate (THD ascorbate) and ubiquinone (coenzyme Q10). Subjects were instructed to apply the moisturizer twice daily, once in the morning and once in the evening. Subjects were evaluated at baseline and after 4, 8, and 12 weeks of product usage. Clinical evaluations were conducted at each visit. A self-assessment questionnaire was conducted at week 4, week 8, and week 12. The self-assessment questionnaire included product efficacy inquiries and product aesthetic inquiries. Digital photography was conducted at baseline, week 8, and week 12. After 8 weeks of twice daily use, clinical evaluation results show that the multi-ingredient anti-aging moisturizer produced a statistically significant improvement in the scores of all clinical grading parameters assessed compared to baseline. A greater statistically significant improvement was seen at 12 weeks. At week 12, there was a statistically significant percentage of favorable results versus unfavorable results in all product efficacy and product aesthetic self-assessment questionnaire results. Digital photography supported the clinical grading and self-assessment questionnaire results. Additionally, the multi-ingredient anti-aging moisturizer is judged to be mild and well tolerated. Several tolerability parameters were assessed at all time points with no statistically significant increase in any of the scores compared to baseline.

Pilot Study of Topical Copper Chlorophyllin Complex in Subjects With Facial Acne and Large Pores.

BACKGROUND: Acne vulgaris is one of the most common skin diseases treated by dermatologists. Salts of copper chlorophyllin complex are semi-synthetic naturally-derived compounds with antioxidant, anti-inflammatory and wound healing activity that have not been previously tested topically in the treatment of acne-prone skin with enlarged pores. OBJECTIVES: This single-center pilot study was conducted to assess the efficacy and safety of a liposomal dispersion of topically applied sodium copper chlorophyllin complex in subjects with mild-moderate acne and large, visible pores over a course of 3 weeks. METHODS: Subjects were supplied with the test product, a topical gel containing a liposomal dispersion of sodium copper chlorophyllin complex (0.1%) with directions to apply a small amount to the facial area twice daily. Clinical assessments were performed at screening/baseline and at week 3. VISIA readings were taken and self-assessment questionnaires were conducted. RESULTS: 10 subjects were enrolled and completed the 3-week study. All clinical efficacy parameters showed statistically significant improvements over baseline at week 3. The study product was well tolerated. Subject questionnaires showed the test product was highly rated. CONCLUSIONS: In this pilot study, a topical formulation containing a liposomal dispersion of sodium copper chlorophyllin complex was shown to be clinically effective and well tolerated for the treatment of mild-moderate acne and large, visible pores when used for 3 weeks.

Surgeons' attitudes are associated with reoperation and readmission rates.

BACKGROUND: Attitudes influence how people make decisions. In an effort to decrease pilot judgment-related accidents, the Federal Aviation Administration teaches new pilots about hazardous attitudes that are believed to be incompatible with safe flight: macho, impulsive, worry, resignation, self-confidence, and antiauthority. If these attitudes are hazardous for pilots and their passengers, they may also be incompatible with the reliable and safe delivery of surgical care. QUESTIONS/PURPOSES: The purposes of this study were (1) to ascertain to what extent surgeons harbor hazardous attitudes; and (2) to determine their relationship, if any, to reoperation and readmission rates. METHODS: We selected validated aviation psychology tools that are used to measure these attitudes in pilots. We converted the aviation scenarios to analogous situations for surgeons and invited all surgeons from one academic program to participate in this study. A total of 41 surgeons were eligible to participate; 37 (90%) completed the attitude prevalence protocol and 31 (76%) had complete reoperation and readmission data for the correlation and regression analysis. Attending orthopaedic surgeons completed the Modified Surgeon Hazardous Attitude Scale as well as a series of additional instruments. RESULTS: Levels of macho thought to be hazardous in pilots were present in nine (24%) surgeons. Similar, elevated levels of self-confidence were found in three (8%) surgeons. High levels of impulsivity were found in 5% (two surgeons) and high levels of antiauthority were found in 3% (one surgeon). Only one (3%) surgeon reported elevated levels of worry and no surgeon reported hazardous levels of resignation. Thirty percent (11 surgeons) of surgeons harbored at least one elevated attitude level. In a regression model, macho attitude levels predicted 19% of the variation in surgeons' rate of readmissions and reoperations. CONCLUSIONS: High levels of hazardous attitudes may not be consistent with the routine delivery of safe surgical care in a teamwork setting where human factors and safe systems are the key to success. Further research is needed to determine if abnormally high levels of these hazardous attitudes impact patient care. LEVEL OF EVIDENCE: Level II, prognostic study. See Guidelines for Authors for a complete description of levels of evidence.

Determinants of disability after proximal interphalangeal joint sprain or dislocation.

BACKGROUND: Sprain or dislocation of the proximal interphalangeal joint may be a useful example of the counterintuitive aspects of recovery as the prognosis is excellent, but protectiveness in response to discomfort often hinders the stretching exercises that are a key component of the recovery process. OBJECTIVE: The aim of this study was to investigate the relationship between disability and pain self-efficacy in this context. METHODS: A total of 82 patients (54 men and 28 women) were enrolled in this prospective study. Finger motion was measured, and the patients completed measures of upper limb-specific disability (the shortened version of the Disabilities of the Arm, Shoulder and Hand questionnaire), symptoms of depression (Patient Health Questionnaire-9), effective coping strategies in response to pain (the Pain Self-Efficacy Questionnaire), and a pain scale at enrollment. RESULTS: Patients were enrolled a mean of 48 days after injury. The final multivariable model accounting for greater disability included lower self-efficacy, greater symptoms of depression, and gender (women have more disability). Lower self-efficacy was also the strongest predictor of pain intensity and finger stiffness. CONCLUSIONS: Effective coping strategies such as self-efficacy facilitate recovery (less disability, pain, and stiffness) after proximal interphalangeal joint sprain/dislocation. LEVEL OF EVIDENCE: Prognostic level I.

Informed shared decision-making and patient satisfaction.

BACKGROUND: Evidence suggests that when patients have a role in medical decisions they are more satisfied with their health care. OBJECTIVE: To assess predictors of patient satisfaction, ratings of the provider's informed shared decision-making (ISDM), and disability among patients with orthopedic pain complaints. RESEARCH DESIGN: A total of 130 patients with nontraumatic painful conditions of the upper extremity were enrolled. Medical encounters were audio recorded and coded by 2 independent coders. Eight ISDM elements and a total ISDM score were evaluated. Bivariate and multivariable analyses were used to answer the study questions. MEASURES: Participants completed the Princess Margaret Hospital Patient Satisfaction with their Doctor Questionnaire to measure satisfaction; the Disabilities of Arm, Shoulder and Hand questionnaire; the Patient Health Questionnaire-9 to measure depression; the Whiteley Index to assess heightened illness concerns; and the pain catastrophizing scale to assess coping strategies in response to pain. RESULTS: Less health anxiety, female gender, the ISDM element Identify choice, and any specific diagnosis determined 22% of the variation in satisfaction. Less health anxiety and unemployed unable to work compared with full-time working status were associated with a better rating of shared decision-making on the ISDM. Catastrophic thinking, female gender, symptoms of depression, and any specific diagnosis were associated with greater disability. Catastrophic thinking and symptoms of depression were the greatest contributors to the variation in disability. CONCLUSIONS: Psychologic factors are the strongest determinants of patient satisfaction, ratings of shared decision-making on the ISDM, and upper-extremity disability. Health anxiety is the most important factor in ratings of patient satisfaction and ISDM, whereas depression and catastrophizing are salient predictors of disability. LEVEL OF EVIDENCE: Prognostic level I.

Steroid-free emollient formulations reduce symptoms of eczema and improve quality of life.

Two over-the-counter products have been clinically tested for efficacy and tolerability in the treatment of atopic dermatitis. Study 1 evaluated a daily maintenance Body Cream (Eucerin Eczema Relief Body Crème) applied twice daily for 14 days, followed by treatment withdrawal for 5 days (regression period) in subjects with a history of atopic dermatitis. Study 2 evaluated an acute treatment (Eucerin Eczema Relief Instant Therapy [Instant Therapy]) for active atopic dermatitis lesions administered for 14 days. Skin barrier function, hydration, tolerability, and relief of symptoms were assessed at baseline, day 7, and day 14. Study 2 also measured itch relief and treatment impact on work, social activities, and sleep. Body Cream significantly improved skin hydration and barrier function (P<.001) at 14 days, with improvements persisting through the 5-day regression phase. Itching was significantly improved in 93.8% of subjects (P<.001). Instant Therapy treatment of atopic dermatitis lesions significantly improved skin hydration and barrier function, as well as symptoms of erythema, pruritus, excoriation, and lichenification, with rapid improvement of itch reported within minutes of the first treatment application. Instant Therapy significantly reduced itch intensity and frequency, and demonstrated beneficial improvements in subjects' quality of life. Body Cream and Instant Therapy were both safe and well tolerated.

Clinical efficacy and safety of a multimodality skin brightener composition compared with 4% hydroquinone.

There are numerous common skin disorders involving hyperpigmentation, including solar lentigines, postinflammatory hyperpigmentation, melasma, freckles, and dyschromia from photoaging. While these conditions are of an aesthetic nature, there is great interest in newer, safer, and more effective treatment modalities. Topical hydroquinone (HQ) has been the gold standard of skin lighteners for many years. However, regulatory authorities around the world are now questioning its safety. A randomized, double-blind, half-face study was conducted in females with moderate to severe facial hyperpigmentation to assess the efficacy and tolerability of 3 new skin brightener formulations containing SMA-432, a prostaglandin E2 inhibitor, compared with 4% HQ. Each subject was assigned 2 of the 4 test materials and was instructed to apply the product on the assigned side of the face twice daily for 12 weeks. Evaluation visits were conducted at baseline and at 4, 8, and 12 weeks. At each visit, subjects were evaluated by a blinded investigator for clinical efficacy and tolerability using grading scales. Standardized digital photography and Chroma Meter assessments were also taken. Self-assessment questionnaires were completed at weeks 4, 8, and 12. Sixty-eight Caucasian subjects (136 half faces) completed the study. All test materials significantly reduced Overall Hyperpigmentation and improved the Investigator's Global Hyperpigmentation Improvement rating at weeks 4, 8, and 12 compared with baseline. SMA-432 exhibited a dose-dependent improvement in hyperpigmentation. There were no major tolerability issues with any of the test materials. Self-assessments were generally favorable for all test materials. At the completion of the trial, subjects rated one of the tested multimodality brightener compositions as the most favorable product and 4% HQ as the least favorable. This study demonstrated that the new non-HQ-containing skin brightener formulations were as effective and equally well tolerated as the gold standard, 4% HQ, in females with facial hyperpigmentation.

Multicenter clinical trial of a home-use nonablative fractional laser device for wrinkle reduction.

BACKGROUND: Until now, nonablative fractional treatments could only be delivered in an office setting by trained professionals. OBJECTIVE: The goal of this work was to perform clinical testing of a nonablative fractional laser device designed for home-use. METHODS: This multicenter trial consisted of two clinical studies with slightly varying treatment protocols in which subjects performed at-home treatments of periorbital wrinkles using a handheld nonablative fractional laser. Both studies included an active treatment phase (daily treatments) and a maintenance phase (twice-weekly treatments). In all, 36 subjects were followed up for as long as 5 months after completion of the maintenance phase and 90 subjects were followed up until the completion of the maintenance phase. Evaluations included in-person investigator assessment, independent blinded review of high-resolution images using the Fitzpatrick Wrinkle Scale, and subject self-assessment. RESULTS: All 124 subjects who completed the study were able to use the device following written instructions for use. Treatments were well tolerated with good protocol compliance. Independent blinded evaluations by a panel of physicians showed Fitzpatrick Wrinkle Scale score improvement by one or more grades in 90% of subjects at the completion of the active phase and in 79% of subjects at the completion of the maintenance phase. The most prevalent side effect was transient posttreatment erythema. LIMITATIONS: Lack of a control group and single-blinded study groups were limitations. CONCLUSION: Safety testing with self-applications by users demonstrated the utility of the device for home use. Independent blinded review of clinical images confirmed the device's proficiency for improving periorbital wrinkles.

Clinical efficacy and safety of a multimodality skin brightener composition compared with 4% hydroquinone.

There are numerous common skin disorders involving hyperpigmentation, including solar lentigines, postinflammatory hyperpigmentation, melasma, freckles, and dyschromia from photoaging. While these conditions are of an aesthetic nature, there is great interest in newer, safer, and more effective treatment modalities. Topical hydroquinone (HQ) has been the gold standard of skin lighteners for many years. However, regulatory authorities around the world are now questioning its safety. A randomized, double-blind, half-face study was conducted in females having moderate to severe facial hyperpigmentation to assess the efficacy and tolerability of 3 new skin brightener formulations containing SMA-432, a prostaglandin E2 inhibitor, compared with 4% HQ. Each subject was assigned 2 of the 4 test materials and was instructed to apply the product on the assigned side of the face twice daily for 12 weeks. Evaluation visits were conducted at baseline and at 4, 8, and 12 weeks. At each visit, subjects were evaluated by a blinded investigator for clinical efficacy and tolerability using grading scales. Standardized digital photography and Chroma Meter assessments were also taken. Self-assessment questionnaires were completed at weeks 4, 8, and 12. Sixty-eight Caucasian subjects (136 half faces) completed the study. All test materials significantly reduced overall hyperpigmentation and improved the Investigator's Global Hyperpigmentation Improvement rating at weeks 4, 8, and 12 compared with baseline. SMA-432 exhibited a dose-dependent improvement in hyperpigmentation. There were no major tolerability issues with any of the test materials. Self-assessments were generally favorable for all test materials. At the completion of the trial, subjects rated one of the tested multimodality brightener compositions as the most favorable product and 4% HQ as the least favorable. This study demonstrated that the new non-HQ-containing skin brightener formulations were as effective and equally well tolerated as the gold standard, 4% HQ, in females with facial hyperpigmentation.

Digital videography assessment of patients' experiences using adapalene-benzoyl peroxide gel in the treatment of acne vulgaris.

BACKGROUND: Acne profoundly affects patients' lives, but the effect of treatment is not fully characterized. OBJECTIVE: The purpose of this study was to explore patients' experiences and viewpoints regarding treatment for mild to moderate acne vulgaris. METHODS: This was an open-label, single-center study of 30 patients with mild to moderate acne vulgaris, treated with adapalene 0.1%/benzoyl peroxide 2.5% (adapalene-BPO gel) once daily for 12 weeks. An acne-specific quality of life questionnaire (Acne-QoL©) was conducted. Each subject's global assessment (SGA) was recorded at baseline and weeks 4, 8, and 12. Photographs were taken and video interviews were recorded. Local tolerability assessments and incidence of adverse events were documented. RESULTS: A statistically significant number of patients were clear/almost clear (treatment success) at week 12 (P<.001). At week 12, patients experienced a 44.1% and 57.1% mean reduction in inflammatory and noninflammatory lesions, respectively. By week 12, 67% of the patients in the video population (n=27) believed they had achieved treatment success (P<.001). Patients reported higher Acne-QoL© scores at week 12 compared to baseline, indicating better quality of life after treatment with adapalene-BPO gel (P<.001 for all domains). No unexpected adverse or serious adverse events were reported. LIMITATIONS: This was an open-label study of 12 weeks duration. CONCLUSION: Overall, patients with mild to moderate acne treated with adapalene-BPO gel showed significant improvement in disease severity and quality of life. The video recordings chronicled the patients' experiences throughout the treatment process.

Correspondence of patient word choice with psychologic factors in patients with upper extremity illness.

BACKGROUND: Studies of patients with back pain, cancer, and in a general medical practice note that the use of certain phrases by a patient when communicating with their health provider can indicate greater disability and distress than expected for patients with a given disorder. However, it is unclear whether such phrases apply to patients with hand and arm disorders. QUESTIONS/PURPOSES: We assessed whether specific patient phrases are associated with symptoms, disability, and psychologic factors in patients with hand and arm disorders. METHODS: We recorded and coded 61 interviews of new patients. Specific expressions of patients were listed and categorized into six phrase categories: "I can't", "Find it and fix it", "Something is wrong", "It's serious", "Deemphasis (hoping)", and "Protective mindset". Patients completed questionnaires for arm-specific disability (DASH), depression (Patient Health Questionnaire [PHQ-9]), pain catastrophizing (Pain Catastrophizing Scale [PCS]), and heightened illness concern (Whiteley Index). RESULTS: Patients who endorsed phrases in the category "I can't" had higher scores on the PCS, Whiteley, DASH, and pain; they also had longer visits. Patients expressing "Something is wrong" had higher scores for the PCS, pain, and duration of visit. Patients using "It's serious" had a higher score for pain. Finally, patients using "Protective mindset" had lower PHQ-9 scores and younger age. CONCLUSIONS: Patient word choice may indicate underlying distress or ineffective coping strategies that represent important opportunities for empathy and support, including evidence-based cognitive and behavioral interventions. LEVEL OF EVIDENCE: Level III, diagnostic study. See the Guidelines for Authors for a complete description of levels of evidence.

Decreased length of stay after TKA is not associated with increased readmission rates in a national Medicare sample.

BACKGROUND: There is a trend toward decreasing length of hospital stay (LOS) after TKA although it is unclear whether this trend is detrimental to the overall postoperative course. Such information is important for future decisions related to cost containment. QUESTIONS/PURPOSES: We determined whether decreases in LOS after TKA are associated with increases in readmission rates. PATIENTS AND METHODS: We retrospectively reviewed the rates and reasons for readmission and LOS for 4057 Medicare TKA patients from 2002 to 2007. We abstracted data from the Medicare Patient Safety Monitoring System. Hierarchical generalized linear modeling was used to assess the odds of changing readmission rates and LOS over time, controlling for changes in patient demographic and clinical variables. RESULTS: The overall readmission rate in the 30 days after discharge was 228/4057 (5.6%). The 10 most common reasons for readmission were congestive heart failure (20.4%), chronic ischemic heart disease (13.9%), cardiac dysrhythmias (12.5%), pneumonia (10.8%), osteoarthrosis (9.4%), general symptoms (7.4%), acute myocardial infarction (7.0%), care involving other specified rehabilitation procedure (6.3%), diabetes mellitus (6.3%), and disorders of fluid, electrolyte, and acid-base balance (5.9%); the top 10 causes did not include venous thromboembolism syndromes. We found no difference in the readmission rate between the periods 2002-2004 (5.5%) and 2005-2007 (5.8%) but a reduction in LOS between the periods 2002-2004 (4.1 ± 2.0 days) and 2005-2007 (3.8 ± 1.7 days). CONCLUSIONS: The most common causes for readmission were cardiac-related. A reduction in LOS was not associated with an increase in the readmission rate in this sample. Optimization of cardiac status before discharge and routine primary care physician followup may lead to lower readmission rates.

Age and obesity are risk factors for adverse events after total hip arthroplasty.

BACKGROUND: Defining the epidemiology of adverse events after THA will aid in the development of strategies to enhance perioperative care. QUESTIONS/PURPOSES: We identified (1) risk factors for adverse events in Medicare beneficiaries while hospitalized after THA and (2) trends in the rates of adverse events. PATIENTS AND METHODS: Data were abstracted from medical records of 1809 Medicare beneficiaries who underwent THA from 2002 to 2007. We used the hierarchical generalized linear modeling approach to assess the odds of change in adverse events over time, the association of adverse events with outcomes, and the relationship of adverse events with patient characteristics by modeling the log-odds of adverse events as a function of demographic and clinical variables adjusted for year variable. RESULTS: The overall rate of adverse events was 5.8%; the 30-day mortality rate was 1.00%. Increased age, obesity, and year of procedure were risk factors for experiencing any adverse event. Annual rates of adverse events from 2002 to 2007 were 9.1%, 8.2%, 4.9%, 4.1%, 3.5%, and 3.0%, respectively. Experiencing any adverse event was associated with an increased length of stay and an increased chance of readmission but not with an increased chance of mortality. The annual rate of all adverse events decreased from 2002-2004 to 2005-2007 (odds ratio = 0.83; 95% confidence interval, 0.74-0.92). CONCLUSIONS: Older and obese patients should be counseled regarding their increased risk for the development of adverse events after THA. The cause of the decline in the rate of adverse events between two time periods is unclear and warrants further investigation to confirm and identify the cause.

Economic evaluations in shoulder pathologies: a systematic review of the literature.

BACKGROUND: Economic evaluations provide decision makers with a tool for reducing health care costs because they assess both the costs and consequences of health care interventions. This study reviewed the quality of published economic evaluations for shoulder pathologies. MATERIALS AND METHOD: A MEDLINE search was conducted to identify articles published from 1980 to 2010 that contained "cost" or "economic" combined with terms for several shoulder disorders and treatments. We selected studies that fit the definition of 1 of the 4 routinely performed economic evaluations: cost-minimization, cost-effectiveness, cost-utility, and cost-benefit analyses. Study quality was determined by measuring adherence to 6 established health economic principles, as described in the literature. RESULTS: The search retrieved 942 studies. Of these, 32 were determined to be economic evaluations, and 53% of the economic evaluations were published from 2005 to 2010. Only 8 of the 32 studies (25%) adhered to all 6 health economic principles. Publication in a nonsurgical journal (P < .05) or in more recent years (P < .01) was significantly associated with higher quality. CONCLUSION: Future health care resource allocation will likely be based on the economic feasibility of treatments. Although the number and quality of economic evaluations of shoulder disorders have risen in recent years, the current state of the literature is poor. Given that availability of such data may factor in private and public reimbursement decisions, there is a clear demand for more rigorous economic evaluations.

A comparison of the tolerability of adapalene 0.1% cream and adapalene 0.1% lotion in healthy individuals.

Two separate single-center, randomized, evaluator-blinded, bilateral (split-face) comparison studies compared the tolerability of adapalene 0.1% cream with adapalene 0.1% lotion in individuals with healthy skin treated once per day for 3 weeks. At each visit, the participants were graded on erythema, scaling, dryness, and stinging/burning (scale: 0 = none to 3 = severe). On the final study visit, the participants completed a Cosmetic Acceptability Questionnaire. Adverse events were recorded at each study visit. A total of 144 participants were enrolled and 130 completed the studies (study 1, n = 66; study 2, n = 64). The lotion formulation was non-inferior to the cream for the success rates and tolerability assessments in both studies. The frequency distributions of worst scores of either 0 (none) or 1 (mild) (study 1; study 2) for adapalene lotion were erythema (98.5%; 40.7%), scaling (100%; 73.5%), dryness (100%; 68.8%), and stinging/burning (98.5%; 100%). The most common treatment-related adverse event was dryness (study 1, cream 2.7% [2 of 75] and lotion 4.0% [3/75]); study 2, cream 2.9% [2 of 69] and lotion 4.3% [3 of 69]. Both the adapalene 0.1% cream and 0.1% lotion formulations were well tolerated and acceptable to the study participants. The adapalene 0.1% lotion provides clinicians with a retinoid for the treatment of acne in a lotion formulation.

The impact of natural sunlight exposure on the UVB-sun protection factor (UVB-SPF) and UVA protection factor (UVA-PF) of a UVA/UVB SPF 50 sunscreen.

OBJECTIVE: To compare the functional stability of Cetaphil UVA/UVB Defense SPF 50 as measured by its ultraviolet B sun protection factor (UVB-SPF) and ultraviolet A protection factor (UVA-PF) values following exposure to natural sunlight versus the UVB-SPF and UVA-PF values of unexposed product. METHODS: These two randomized, controlled, evaluator-blinded, single-center trials were conducted according to the methods outlined in the 2007 Proposed Amendment to the Final Monograph, "Sunscreen Drug Products for Over-the-Counter Human Use." Sunscreen samples were applied to glass plates and exposed to ultraviolet radiation in the form of natural sunlight in four minimal erythemal doses (MED) ranging from 2­6 MED (42­36 mJ/cm2). Three test sites were identified on the back of each study subject. Exposed sunscreen (one of four doses), unexposed sunscreen, and a UVB-SPF 15 control sunscreen were applied to the three test sites in a randomized fashion, followed by UV irradiation of incremental doses. Erythema and pigment darkening responses were assessed immediately following UV exposure and again 16­24 hours (erythema) or three to 24 hours (pigment darkening) after exposure. UVB-SPF and UVA-PF values were calculated for the exposed and unexposed samples. RESULTS: The calculated UVB-SPF and UVA-PF values for all test samples (exposed and unexposed) were >50 and >9, respectively, which were greater than the stated UVB-SPF and UVA-PF values on the product label. No differences were observed between the exposed and unexposed samples in UVB-SPF or UVA-PF. CONCLUSION: The UVA and UVB protection using standard evaluation techniques of Cetaphil UVA/UVB Defense SPF 50 remains stable despite exposure of the sunscreen to natural sunlight containing UVB ranging from 2­16 MED (41­336 mJ/cm2) and coexistent UVA.

Predictors of success on the American Board of Orthopaedic Surgery examination.

Predictors of success of orthopaedic residents on the American Board of Orthopaedic Surgery (ABOS) examination are controversial. We therefore evaluated numerous variables that may suggest or predict candidate performance on the ABOS examination. We reviewed files of 161 residents (all graduates) from one residency program distributed into two study groups based on whether they passed or failed their first attempt on the ABOS Part I or Part II examination from 1991 through 2005. Predictors of success/failure on the ABOS I included the mean percentile score on the Orthopaedic In-Training Examination (OITE) (Years 2 through 4), the percentile OITE score in the last year of training, US Medical Licensing Examination (USMLE) score, Dean's letter, election to Alpha Omega Alpha (AOA), and number of honors in selected third-year clerkships. All but the USMLE score predicted passing the ABOS Part II examination. These data suggest there are objective predictors of residents' performance on the ABOS Part I and Part II examinations.