Novel Tretinoin 0.05% Lotion for the Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris: Assessment of Efficacy and Safety in Patients Aged 9 Years and Older.

BACKGROUND: Topical tretinoin has been extensively studied in clinical trials, and its essential role in the treatment of acne vulgaris (acne) established through evidence-based guidelines. OBJECTIVE: To evaluate efficacy, safety, and tolerability of a novel tretinoin 0.05% lotion in moderate-to-severe acne in patients aged 9 years and older. METHODS: A total of 1640 patients, 9-58 years of age were randomized to receive tretinoin 0.05% lotion or vehicle in two double-blind, placebo-controlled 12-week, 2-arm, parallel group studies evaluating safety and efficacy (inflammatory and noninflammatory lesion counts and acne severity using Evaluator Global Severity Scores [EGSS]). In addition, patients completed a patient satisfaction survey (PSS), Acne-specific quality of life (QoL) questionnaire and assessed their facial skin for shininess/oiliness improvement. The data from these two independent studies were pooled and analyzed. RESULTS: Tretinoin 0.05% lotion demonstrated statistically significant superiority to vehicle in reducing inflammatory and noninflammatory lesion counts (both P less than .001) at week 12 and improving acne severity (P less than .001). At week 12, mean percent change in inflammatory and noninflammatory lesions were 52% and 46%, respectively. Treatment success (a 2-grade improvement in EGSS and 'clear' or 'almost clear' was reported in 18% of patients. Tretinoin 0.05% lotion also showed significantly greater benefits relative to vehicle control in terms of patient satisfaction (P less than .001) and acne-specific QoL domains. Tretinoin 0.05% lotion was very well tolerated with no substantive differences in cutaneous tolerability among treatment groups. No patients discontinued treatment because of adverse events. LIMITATIONS: Data from controlled studies may differ from clinical practice. CONCLUSIONS: Tretinoin 0.05% lotion provides statistically significant greater efficacy than vehicle with a highly favorable safety and tolerability profile in moderate-to-severe acne patients. J Drugs Dermatol. 2018;17(10):1084-1091.

FV-100 versus valacyclovir for the prevention of post-herpetic neuralgia and the treatment of acute herpes zoster-associated pain: A randomized-controlled trial.

This prospective, parallel-group, randomized, double-blind, multicenter study compared the efficacy and safety of FV-100 with valacyclovir for reducing pain associated with acute herpes zoster (HZ). Patients, ≥50 years of age, diagnosed with HZ within 72 h of lesion appearance who had HZ-associated pain, were randomized 1:1:1 to a 7-day course of either FV-100 200 mg QD (n = 117), FV-100 400 mg QD (n = 116), or valacyclovir 1000 mg TID (n =117). Efficacy was evaluated on the basis of the burden of illness (BOI; Zoster Brief Pain Inventory scores); incidence and duration of clinically significant pain (CSP); pain scores; incidence and severity of post-herpetic neuralgia (PHN); and times to full lesion crusting and to lesion healing. Safety was evaluated on the basis of adverse event (AE)/SAE profiles, changes in laboratory and vital signs values, and results of electrocardiograms. The burden of illness scores for pain through 30 days were 114.5, 110.3, and 118.0 for FV-100 200 mg, FV-100 400 mg, and valacyclovir 3000 mg, respectively. The incidences of PHN at 90 days for FV-100 200 mg, FV-100 400 mg, and valacyclovir 3000 mg were 17.8%, 12.4%, and 20.2%, respectively. Adverse event and SAE profiles of the two FV-100 and the valacyclovir groups were similar and no untoward signals or trends were evident. These results demonstrate a potential for FV-100 as an antiviral for the treatment of shingles that could both reduce the pain burden of the acute episode and reduce the incidence of PHN compared with available treatments.

Herpes zoster vaccine awareness among people ≥ 50 years of age and its implications on immunization.

Herpes zoster (HZ) vaccine was recently approved for adults ≥ 50 years of age and has been shown to reduce the incidence of zoster, postherpetic neuralgia (PHN), and associated healthcare costs. However, currently HZ immunization is sub-optimal. We examined awareness of HZ and of the HZ vaccine. Information was gathered via a one-page survey given to patients ≥ 50 years of age presenting at the dermatology clinic. From the surveyed population of 1000 individuals, the HZ vaccination rate was 11.9 percent. Vaccination coverage was highest for the ≥ 70 age group (18.3%), followed by age groups 60-69 (8.9%) and 50-59 (1.4%). Individuals with female gender, older age (≥ 70 years), higher level of education (college and beyond), retired employment status, memory of chickenpox, knowledge of shingles, and history of shingles and influenza vaccination in the past year all were more likely to have heard of and have received the HZ vaccine (except female gender, education level, and awareness of shingles). Our study suggests lack of awareness to be a significant factor in non-immunization with zoster vaccine. Targeting adults in younger age groups and minorities would be beneficial towards increasing zoster vaccine awareness and thus preventing herpes zoster and its many complications.

Ranking the dermatology programs based on measurements of academic achievement.

BACKGROUND: The only dermatology rankings in the past were based on National Institutes of Health (NIH) funding and journal citations. OBJECTIVE: To determine the highest ranking academic dermatology programs based on 5 outcome measures and on an overall ranking scale. To the best of our knowledge, this is the first report to rank the dermatology programs on 4 of the following outcome measures of academic achievement and with an overall ranking. METHODS: We collected extensive 2001 to 2004 data ranging from total publications to grant funding on 107 U.S. dermatology programs and their full-time faculty. Data from part-time and volunteer faculty were not used. MAIN OUTCOME MEASURES: Publications in 2001 to 2004; NIH funding in 2004; Dermatology Foundation grants in 2001 to 2004; faculty lectures in 2004 delivered at national conferences; number of full-time faculty members who were on the editorial boards of the top 3 U.S. dermatology journals and the top 4 subspecialty journals RESULTS: We used the 5 outcome measures to tabulate the highest ranking programs in each category. Using a weighted ranking system, we also tabulated the overall top 30 dermatology programs based on these 5 outcome measures. LIMITATIONS: We were not able to determine the total amount of NIH funding in dollars of the dermatology divisions. The impact factors of the journal in which these publications appeared was not factored into our calculations. Since faculty members may collaborate on the same publication, some publications may have been double-counted. CONCLUSION: In descending order, the 5 highest ranked academic programs are the University of Pennsylvania; University of California, San Francisco; Yale-New Haven Medical Center; New York University; and University of Michigan. This ranking system may allow residents and faculty to improve the academic achievements at their respective programs.

Dermatology residency program characteristics that correlate with graduates selecting an academic dermatology career.

OBJECTIVE: To examine the characteristics of 107 dermatology residency programs to determine which factors are correlated with producing academic dermatologists to help reverse the trend of a growing shortage of academic dermatologists. DESIGN: We collected data ranging from total publications to grant funding. Extensive Internet searches were completed to obtain most of the data. Individual programs were contacted as needed to obtain any missing data that were not found on the program's Web site. SETTING: Dermatology residency programs (departments and divisions) in the United States. MAIN OUTCOME MEASURES: Factors that correlated with producing full-time academic dermatologists. RESULTS: We tabulated and analyzed characteristics of 107 dermatology residency programs. Total full-time faculty members in 2004, total publications in 2004, and total publications from January 1, 2001, to December 31, 2004, were the 3 factors most strongly correlated with producing full-time faculty. National Institutes of Health and Dermatology Foundation grants and American Skin Association grant recipients were the 3 characteristics most strongly inversely correlated with producing full-time faculty. Those who entered academic dermatology tended to stay at the same program where they completed a dermatology residency, especially if this program was considered a "smaller" program. CONCLUSIONS: The programs' characteristics of total publications in 2004 and from 2001 to 2004 were 2 of the 3 factors most strongly positively correlated with dermatology residents entering academic dermatology. Encouraging residents to publish may be a window to motivate them toward a career in academic dermatology.