Efficacy and safety of apremilast in patients with moderate-to-severe genital psoriasis: Results from DISCREET, a phase 3 randomized, double-blind, placebo-controlled trial.

BACKGROUND: Genital psoriasis can be stigmatizing, is highly prevalent among patients with psoriasis, and has limited treatment options. Apremilast is a unique oral immunomodulating phosphodiesterase 4 inhibitor approved for psoriasis treatment. OBJECTIVE: To assess the efficacy and safety of apremilast 30 mg twice daily in patients with genital psoriasis. METHODS: DISCREET, a phase 3, placebo-controlled trial (NCT03777436), randomized patients with moderate-to-severe genital psoriasis (stratified by affected body surface area <10% or ≥10%) to apremilast or placebo for a 16-week period, followed by an apremilast extension period. Week 16 results are presented. RESULTS: Patients were randomized to apremilast (n = 143) or placebo (n = 146). At Week 16, 39.6% and 19.5% of apremilast and placebo patients, respectively, achieved a modified static Physician Global Assessment of Genitalia response (primary endpoint; score of 0/1, ≥2-point reduction); treatment difference was significant (20.1%, P = .0003). Improvements in genital signs and symptoms, skin involvement, and quality of life were observed. Common treatment-emergent adverse events were diarrhea, headache, nausea, and nasopharyngitis. LIMITATIONS: Lack of active-comparator. CONCLUSIONS: Apremilast demonstrated statistically and clinically meaningful genital Physician Global Assessment responses and improvement of signs, symptoms, severity, and quality of life in this first randomized, controlled study of an oral systemic treatment in patients with genital psoriasis.

Randomized phase 3 evaluation of trifarotene 50 µg/g cream treatment of moderate facial and truncal acne.

BACKGROUND: Acne vulgaris often affects the face, shoulders, chest, and back, but treatment of nonfacial acne has not been rigorously studied. OBJECTIVES: Assess the safety and efficacy of trifarotene 50 µg/g cream, a novel topical retinoid, in moderate facial and truncal acne. METHODS: Two phase III double-blind, randomized, vehicle-controlled, 12-week studies of once-daily trifarotene cream versus vehicle in subjects aged 9 years or older. The primary end points were rate of success on the face, as determined by the Investigator's Global Assessment (clear or almost clear and ≥2-grade improvement), and absolute change from baseline in inflammatory and noninflammatory counts from baseline to week 12. The secondary end points were rate of success on the trunk (clear or almost clear and ≥2-grade improvement) and absolute change in truncal inflammatory and noninflammatory counts from baseline to week 12. Safety was assessed through adverse events, local tolerability, vital signs, and routine laboratory testing results. RESULTS: In both studies, at week 12 the facial success rates according to the Investigator's Global Assessment and truncal Physician's Global Assessment and change in inflammatory and noninflammatory lesion counts (both absolute and percentage) were all highly significant (P < .001) in favor of trifarotene when compared with the vehicle. LIMITATIONS: Adjunctive topical or systemic treatments were not studied. CONCLUSION: These studies demonstrate that trifarotene appears to be safe, effective, and well tolerated in treatment of both facial and truncal acne.

Three Dermatologists Who Were Nominated for a Nobel Prize: Albert Neisser, Erich Hoffmann, and Aaron B. Lerner.

During the past 125 years, three dermatologists have been nominated for the Nobel Prize in Physiology or Medicine: Albert Neisser (1855-1916), Erich Hoffmann (1868-1959), and Aaron B. Lerner (1920-2007). Neisser was nominated 22 times for his discovery of the gonococcus and for his work on the serologic testing for syphilis through complement fixation. Hoffman was nominated three times for his role in the discovery of Treponema pallidum. Lerner was nominated twice, once for his work on melanocyte-stimulating hormone and a second time for his work on melatonin. Although neither Neisser, Hoffmann, nor Lerner won the Nobel Prize, it is still a notable accomplishment that each of them was nominated multiple times for this prestigiousaward. This contribution highlights the lives and careers of these three distinguished dermatologists, including the landmark discoveries they made that led to their being nominated for a Nobel Prize.

Eponyms that honor Jewish dermatologists: A celebration and a remembrance, Part three: Jewish physicians who practiced during the Holocaust and in its aftermath.

Part III of this contribution continues to celebrate the many contributions that Jewish physicians have made to advance the specialty of dermatology, as reflected by eponyms that honor their names. Part I covered the years before 1933, a highly productive period of creativity by Jewish dermatologists, especially in Germany and Austria. The lives of 17 Jewish physicians and their eponyms were described in Part I. Part II focused on the years of 1933 to 1945, when the Nazis rose to power in Europe, and how their anti-Semitic genocidal policies affected leading Jewish dermatologists caught within the Third Reich. Fourteen Jewish physicians and their eponyms are discussed in Part II. Part III continues the remembrance of the Holocaust era by looking at the careers and eponyms of an additional 13 Jewish physicians who contributed to dermatology during the period of 1933 to 1945. Two of these 13 physicians, pathologist Ludwig Pick (1868-1944) and neurologist Arthur Simons (1877-1942), perished in the Holocaust. They are remembered by the following eponyms of interest to dermatologists: Lubarsch-Pick syndrome, Niemann-Pick disease, and Barraquer-Simons syndrome. Four of the 13 Jewish physicians escaped the Nazis: Felix Pinkus (1868-1947), Herman Pinkus (1905-1985), Arnault Tzanck (1886-1954), and Erich Urbach (1893-1946). Eponyms that honor their names include nitidus Pinkus, fibroepithelioma of Pinkus, Tzanck test, Urbach-Wiethe disease, Urbach-Koningstein technique, Oppenheim-Urbach disease, and extracellular cholesterinosis of Karl-Urbach. The other seven Jewish physicians lived outside the reach of the Nazis, in either Canada, the United States, or Israel. Their eponyms are discussed in this contribution. Part III also discusses eponyms that honor seven contemporary Jewish dermatologists who practiced dermatology after 1945 and who continue the nearly 200 years of Jewish contribution to the development of the specialty. They are A. Bernard Ackerman (1936-2008), Irwin M. Braverman, Sarah Brenner, Israel Chanarin, Maurice L. Dorfman, Dan Lipsker, and Ronni Wolf. Their eponyms are Ackerman syndrome, Braverman sign, Brenner sign, Chanarin-Dorfman syndrome, Lipsker criteria of the Schnitzler syndrome, and Wolf's isotopic response.

Epicanthoplasty: Social and historical perspectives.

The epicanthus is a fold of skin covering the inner corner of the eye which blends into the nasal skin. It is a cosmetic feature of many populations of the world. The surgical alteration of this structure was first developed for the epicanthus found in such congenital genetic conditions as Down syndrome in the West. In the past century and a half, in what may be a reaction to the Western portrayal of skin overlying the eye and of Shakespeare's descriptions of characters with epicanthic folds, surgical techniques have arisen for pure cosmetic intent to alter the Asian eyelid. These procedures have almost wholly become undertaken by patients and surgeons of East Asian descent. Since 1989, the epicanthus surgery literature has been penned predominantly by authors of East Asian descent.

Eponyms and clinical entities from the land of Israel.

Seven eponyms have been pioneered by dermatologists in Israel: Brenner's sign, Chanarin-Dorfman syndrome, granulated sweetener packet sign, isopathic phenomenon of Sagher, lanolin paradox, Nakar-Ingber disease, and Wolf's isotopic response. In addition, there are three id reactions described by Israeli dermatologists: leishmanid, pediculid, and scabid. There is also the acronym PEMPHIGUS, which stands for the causative reasons for pemphigus. We celebrate these eponyms and clinical entities, which reflect the impressive progress made by dermatologists in Israel during the past century who have helped to build an academic, vibrant, and dynamic specialty in the Holy Land.

Rosacea Core Domain Set for Clinical Trials and Practice: A Consensus Statement.

Importance: Inconsistent reporting of outcomes in clinical trials of rosacea is impeding and likely preventing accurate data pooling and meta-analyses. There is a need for standardization of outcomes assessed during intervention trials of rosacea. Objective: To develop a rosacea core outcome set (COS) based on key domains that are globally relevant and applicable to all demographic groups to be used as a minimum list of outcomes for reporting by rosacea clinical trials, and when appropriate, in clinical practice. Evidence Review: A systematic literature review of rosacea clinical trials was conducted. Discrete outcomes were extracted and augmented through discussions and focus groups with key stakeholders. The initial list of 192 outcomes was refined to identify 50 unique outcomes that were rated through the Delphi process Round 1 by 88 panelists (63 physicians from 17 countries and 25 patients with rosacea in the US) on 9-point Likert scale. Based on feedback, an additional 11 outcomes were added in Round 2. Outcomes deemed to be critical for inclusion (rated 7-9 by ≥70% of both groups) were discussed in consensus meetings. The outcomes deemed to be most important for inclusion by at least 85% of the participants were incorporated into the final core domain set. Findings: The Delphi process and consensus-building meetings identified a final core set of 8 domains for rosacea clinical trials: ocular signs and symptoms; skin signs of disease; skin symptoms; overall severity; patient satisfaction; quality of life; degree of improvement; and presence and severity of treatment-related adverse events. Recommendations were also made for application in the clinical setting. Conclusions and Relevance: This core domain set for rosacea research is now available; its adoption by researchers may improve the usefulness of future trials of rosacea therapies by enabling meta-analyses and other comparisons across studies. This core domain set may also be useful in clinical practice.

Efficacy and safety of naftifine HCl Gel 2% in the treatment of interdigital and moccasin type tinea pedis: pooled results from two multicenter, randomized, double-blind, vehicle-controlled trials.

BACKGROUND: Tinea pedis is the most common chronic fungal infection. Naftifine hydrochloride is a topical antifungal of the allylamine class, displaying fungicidal activity and clinically significant anti-bacterial and anti-inflammatory effects. OBJECTIVE: To evaluate the efficacy and safety of two-weeks once daily application of naftifine gel 2% in the treatment of tinea pedis. METHODS: At baseline, 1715 subjects were randomly assigned 2:1 to naftifine gel 2% (n=1144) and vehicle (n=571). Efficacy consisting of mycologic determination (KOH and dermatophyte cultures) and scoring of clinical symptom severity was evaluated at baseline and weeks 2, 4, and 6. Efficacy was analyzed in 1174 subjects (n=782, naftifine; n=392, vehicle) with a positive baseline dermatophyte culture and KOH for whom week 6 assessments were available. Safety was evaluated by adverse events (AE) and laboratory values in 1714 subjects (n=1143, naftifine; n=571, vehicle). RESULTS: Subjects treated with naftifine gel 2% for interdigital-type tinea pedis demonstrated greater improvement from baseline for complete cure (P=0.001), mycological cure (P<0.0001), and treatment effectiveness (P<0.0001) as early as 2 weeks when compared to vehicle; however the highest response rates were seen 4-weeks post treatment (P<0.0001, for all endpoints). Statistically significant results for complete cure, mycological cure, and treatment effectiveness (P<0.0001, for all endpoints) were also seen at week 6 among subjects with moccasin-type tinea pedis. Treatment related adverse events were minimal. CONCLUSIONS: Treatment with naftifine gel 2% applied once daily for two weeks is well-tolerated and is effective in treating both interdigital-type and moccasin-type tinea pedis. Continuous improvement is observed from the end of treatment to four-weeks after treatment cessation among key outcome measures (complete cure, mycological cure, and treatment effectiveness) as well as clinical signs and symptoms (erythema, scaling, and pruritus)

Dermatologists with extraordinary life stories: Nikolai Tsankov and his island in Antarctica.

An island in Antarctica has been named in honor of the distinguished Bulgarian dermatologist Nikolai Tsankov. This contribution tells the story of Tsankov Island, and the remarkable man behind the eponym. He has participated in multiple expeditions to Antarctica as a pioneer in studying the effects its climactic conditions on healthy skin.

Eponyms that honor Jewish dermatologists: A celebration and a remembrance, Part one: Jewish physicians who practiced before 1933.

This multipart feature celebrates the Jewish contribution to dermatology over the past 200 years, as reflected by medical eponyms that honor the names of Jewish physicians. Many of these physicians practiced in Germany and Austria after the emancipation of Jews in Europe. Part one discusses 17 physicians who practiced medicine before the Nazi takeover of Germany during 1933. Examples of such eponyms from this period include the Auspitz phenomenon, Henoch-Schonlein purpura, Kaposi's sarcoma, Koebner phenomenon, Koplik spots, Lassar paste, ital Neisseria gonorrhoeae, and Unna boot. One of these physicians, Paul Ehrlich (1854-1915), became the first Jew to be awarded the Noble Prize in Medicine or Physiology, an honor he received in 1908 and shared with his fellow Jew, Ilya Ilyich Mechnikov (1845-1916). Parts two and three of this project will present the names of 30 more Jewish physicians honored by medical eponyms and who practiced medicine during the Holocaust era and its aftermath, including those physicians who perished at the hands of the Nazis.

Eponyms that honor Jewish dermatologists: A celebration and a remembrance, Part two: Jewish physicians who practiced between 1933 and 1945.

This is the second installment of a three-part contribution that highlights the achievements of Jewish dermatologists as reflected by eponyms that honor their names. It covers the period 1933-1945 when the Nazis took over Germany and how the lives of 14 notable Jewish physicians, mostly in Germany, were impacted during the Holocaust. Many of them fled from the persecution, bringing their academic talents to other lands such as the United States. At least one committed suicide (Fritz Juliusberg), and three others perished in the Holocaust (Abraham Buschke, Lucja Frey-Gottesman, and Karl Herxheimer). They are remembered by eponyms including Neisser-Juliusberg pityriasis lichenoides chronica, Buschke-Ollendorff syndrome, Frey syndrome, and Jarisch-Herxheimer reaction. It made little difference to the Nazis that several of the 14 physicians had converted to Christianity. All were persecuted by the Nazis and had their professional careers destroyed. Two of the 14 physicians lived outside of the Third Reich (Bruno Bloch and Emanuel Libman) and were spared the suffering endured by the other 12. This tragic account of Jewish dermatologists during the Holocaust, and the eponyms that honor them, will continue in part three of this contribution.

British Royalty and Aristocracy: Their skin maladies Part II. Queen Mary II's death from hemorrhagic smallpox.

In 1694, Queen Mary II (1662-1694) died at age 32 of hemorrhagic smallpox, a rare and fatal form of the viral infection. This contribution presents the clinical features of Queen Mary II's smallpox infection. It also reviews, from a modern-day perspective, the disseminated intravascular coagulopathy involved in the pathophysiology of hemorrhagic smallpox, which is characterized by thrombocytopenia, coagulation factor deficiency, and hypofibrinogenemia.

Ceratum Galeni: An old eponym honoring Galen and his cold cream.

Ceratum Galeni is an old eponym honoring the name of Galen of Pergamum (129 to cca 216 CE) and a cold cream he described more than 1,800 years ago. We traced this eponym back to the 14th and 16th centuries in published medical texts by Guy de Chauliac (ca 1300-1368) and Andreas Vesalius (1514-1564). We also found a 4th-century reference in a medical work by Oribasius (ca 320-403 CE) to a mixture of wax and oil of roses based on Galen's cold cream formula. We present the images of a 19th-century apothecary white porcelain jar from Paris, France, on which appears the words Cerat Galeni, as well as a 20th-century oil painting by the American artist Robert Thom (1915-1979), which shows Galen administering his cold cream to a woman. Today, the composition of cold cream is formulated differently from Galen's original version, although the basic concept of cold cream as an oil and water emulsion remains the same. The widespread mention of Ceratum Galeni across the centuries and the popularity of cold creams today are striking examples of Galen's enormous influence on medicine as one of its founding fathers.

Editors and Journals: Part II-Relationship between the Editor-in-Chief and the Owner of the Journal: The Consequences When Editorial Independence Dissolves.

A symbiotic relationship between the editor and the owner of a medical journal is important for the journal to fulfill successfully the expectations of its readers and authors. Editorial freedom and transparency by owner of the journal are important qualities that enable the editor to provide valid scientific information in an unbiased manner. Unresolved impedance of editorial freedom or the persistent lack of transparency or both frequently results in untenable consequences for editor and often a substantial defamation of the journal's credibility. Unfortunately, misguided and inappropriate behavior by a medical society or the publication owner repeatedly occurs with the same devastating effect for the editor: prompt, unanticipated, and unjustified termination of the position at the journal. Alternatively, conditions imposed by a journal's owner may lead to the resignation of the editor because of untenable conditions. Because the owner does not have to account for its actions and there is no recourse for the editor, currently there seems to be no effective measures to prevent this tragic sequence of events in the future.