Treatment of Plaque-Type Psoriasis With Oral CF101: Data from a Phase II/III Multicenter, Randomized, Controlled Trial.

BACKGROUND: CF101, an adenosine A3 receptor agonist, is an orally bioavailable small molecule drug presenting an anti-psoriatic effect demonstrated in a Phase 2 clinical trial in psoriasis patients.
OBJECTIVE: To evaluate the safety and efficacy of CF101 treatment in a Phase 2/3 study in patients with moderate to severe plaque-type psoriasis.
METHODS: This multicenter, double-blind, 2-segment, placebo-controlled study randomized subjects with moderate to severe plaque psoriasis to CF101 1 or 2 mg, or placebo twice daily. At either week 12 (Segment 1) or 16 (Segment 2), the placebo group crossed over to CF101 BID through week 32 in an open-label fashion. At week 12, following an interim analysis, the CF101 1mg group was discontinued due to futility. The primary endpoint was proportion of patients achieving ≥75% improvement in Psoriasis Area Severity Index (PASI 75). Efficacy testing was performed using the Cochran-Mantel Haenszel test, the primary analysis of PASI 75 was performed at the 0.035 significance level.
RESULTS: CF101 had an excellent safety profile at all tested dosages with a profile similar to the placebo group. The most common adverse events were infections and gastrointestinal events, and there was no cumulative intolerance over the 32-week dosing period. The study did not meet the primary endpoint of PASI 75 at week 12 (2 mg: 8.5% vs. placebo: 6.9%, P=0.621). However, at week 32, PASI mean percent improvement with CF101 2 mg was 57% (P<0.001) compared to baseline, with linear improvement in PASI 50 (63.5%), 75 (35.5%), 90 (24.7%), and 100 (10.6%).
CONCLUSIONS: Oral CF101 was found to be safe and very well tolerated, demonstrating evidence of efficacy in patients with moderate to severe plaque psoriasis through 32 weeks of treatment.

J Drugs Dermatol. 2016;15(8):931-938.

Randomized, controlled study of innovative spray formulation containing ozonated oil and α-bisabolol in the topical treatment of chronic venous leg ulcers.

OBJECTIVE: Ozone therapy has a large clinical application in many therapeutic areas because of its well-known antimicrobial, immunological, and oxygenating properties. Recently, interest has grown regarding the application of ozonated oil for vascular leg ulcer treatment. The efficacy of an innovative spray formulation of ozonated oil and α-bisabolol combination in the topical treatment of chronic venous leg ulcers was evaluated compared with standard epithelialization cream. DESIGN: A randomized controlled trial was conducted. SETTING: A total of 29 patients older than 18 years with chronic venous leg ulcers for less than 2 years' duration were assessed. PATIENTS: Patients were randomized to receive daily application of both ozonated oil and α-bisabolol or the control cream (vitamin A, vitamin E, talc, and zinc oxide) for 30 days. MAIN OUTCOME MEASURES: Patients were evaluated on 4 different visits: at days 0, 7, 14, and 30. At each visit, the wound surfaces were measured. Wound area ratio and the speed of ulcer healing were calculated. MAIN RESULTS: At the end of treatment, the proportion of patients with complete ulcer healing was higher with ozonated oil and α-bisabolol formulation (25% vs 0%). Furthermore, the changes in ulcer surface area were significant for ozonated oil and α-bisabolol formulation only (P < .05), in particular, observing a significant and progressive reduction of the wound surface by 34%, 59%, and 73%, after 7, 14, and 30 days of treatment, respectively. CONCLUSION: The innovative spray formulation of ozonated oil and α-bisabolol combination shows promise as an important new therapeutic option in the adjuvant treatment of venous ulcers.

Pemphigus vulgaris - approach and management.

The place of pemphigus vulgaris (PV) among autoimmune bullous dermatoses is well known. In pemphigus, IgG autoantibodies are directed against desmogleins 1 and 3, which are part of the cadherin family of cell-cell adhesion molecules. These structures are responsible for maintaining the intercellular adherence in stratified squamous epithelia, such as the skin and oral mucosa. The incidence of autoimmune bullous dermatoses is steadily increasing, being associated with a high degree of morbidity. The pathophysiology of these dermatoses is very well understood, complemented by recent genetic studies. The gold standard for the diagnosis of pemphigus vulgaris is the detection of autoantibodies or complement component 3 by direct immunofluorescence microscopy of a perilesional biopsy. Early diagnosis and initiation of treatment are necessary in order to achieve a favorable prognosis. Although the first line of treatment is corticotherapy, there are no clear guidelines on dosing regimens, and long-term adverse effects are important. Corticosteroid-sparing adjuvant therapies have been employed in the treatment of PV, aiming to reduce the necessary cumulative dose of corticosteroids. In addition, therapies with anti-CD20 antibodies are used, but antigen-specific immune suppression-based treatments represent the future.

Association between personality type, affective distress profile and quality of life in patients with psoriasis vs. patients with cardiovascular disease.

Common chronic conditions, such as cardiovascular diseases and psoriasis, are associated with increased psychological distress. Health-related quality of life and personality type in patients with these two diseases were evaluated, including the patient's ability to respond truthfully or his/her tendency to be introverted or extroverted. The subjects (n=63) responded to questionnaires including: SF-36 questionnaire, Eysenck test and the questionnaire of the affective distress profile designed to assess the subjective dimension of functional negative emotions, dysfunctional negative emotions and positive emotions. Psoriasis patients had significantly higher average scores of physical functions and limitations brought on by emotional problems. Emotional instability was common for both types of patients and anxiety was associated with a low level of education. Overall, we believe that it is necessary to include items evaluating the patients' affective profile and personality in the assessment protocols of these diseases. These items could help the clinician in identifying possible factors that signal worsening of the disease or of non-response to treatment.

Imaging techniques in the diagnosis and monitoring of psoriasis.

Plaque psoriasis is a chronic, immune-mediated disease, which has a multifactorial etiopathogenesis. Practical non-invasive techniques to monitor plaque psoriasis progression and treatment are necessary. Imaging techniques available for psoriasis assessment may vary in terms of resolution, depth of penetration and visual representation. This review summarizes the current developments in the field of psoriasis non-invasive imaging techniques, such as dermoscopy, conventional ultrasound and high frequency ultrasonography (HFUS), videocapillaroscopy (VC), reflectance confocal microscopy (RCM), optical microangiography (OMAG), laser Doppler imaging (LDI), multiphoton tomography (MPT) and optical coherence tomography (OCT). The aim was to collect and analyze data concerning types, indications, advantages and disadvantages of modern imaging techniques for in vivo psoriasis assessment. We focused on two main methods, videodermoscopy and HFUS, which can be included in daily dermatologists' practice and which may assist in establishing diagnosis, as well as monitoring response to topical and/or systemic therapy of psoriasis. Dermoscopy may be useful for a first evaluation and may offer an understanding of the type and distribution of blood vessels, as well as the color of the scale and the background of the lesion. Videodermoscopy allows magnification and offers a detailed evaluation of the vessel type. The utility of HFUS consists mainly in monitoring therapy response. These methods may be comparable with virtual histopathology.

Toxic Epidermal Necrolysis - A Case Report.

Toxic epidermal necrolysis (TEN) is an acute, life-threatening muco-cutaneous disease, often induced by drugs. It is characterized by muco-cutaneous erythematous and purpuric lesions, flaccid blisters which erupt, causing large areas of denudation. The condition can involve the genitourinary, pulmonary and, gastrointestinal systems. Because of the associated high mortality rate early diagnosis and treatment are mandatory. This article presents the case of a sixty-six years old male patient, known to have cirrhosis, chronic kidney failure, and diabetes mellitus. His current treatment included haemodialysis. He was hospitalized as an emergency to the Dermatology Department for erythemato-violaceous, purpuric patches and papules, with acral disposition, associated with rapidly spreading erosions of the oral, nasal and genital mucosa and the emergence of flaccid blisters which erupted quickly leaving large areas of denudation. Based on the clinical examination and laboratory investigations the patient was diagnosed with TEN, secondary to carbamazepine intake for encephalopathic phenomena. The continuous alteration in both kidney and liver function and electrolyte imbalance, required him to be transferred to the intensive care unit. Following pulse therapy with systemic corticosteroids, hydro-electrolytic re-equilibration, topical corticosteroid and antibiotics, there was a favourable resolution of TEN. The case is of interest due to possible life-threatening cutaneous complications, including sepsis and significant fluid loss, in a patient with associated severe systemic pathology, highlighting the importance of early recognition of TEN, and the role of a multidisciplinary team in providing suitable treatment.

THE AUTOIMMUNE CONSTELLATION IN LICHEN AMYLOIDOSIS.

Localized cutaneous amyloidosis is a rare disease among white people, being more common in South-Asia, China and South America. The disease is characterized by deposition of amyloid material in the papillary dermis without visceral involvement. Nevertheless, there is a growing list of immune-mediated disorders that have been linked to cutaneous amyloidosis. We present two cases of concomitant occurrence of lichen amyloidosis and autoimmune thyroiditis/atopic dermatitis in two Caucasian women.

BLASTIC PLASMACYTOID DENDRITIC CELL NEOPLASM --A RAPIDLY EVOLVING ENTITY. CASE REPORT.

Blastic plasmacytoid dendritic cell neoplasm (BPDCN), CD4+/CD56+hematodermic neoplasm was formally known as blastic NK-cell lymphoma. It is in fact a form of acute myeloid leukemia notable for highly aggressive behavior with cutaneous, lymph node and bone marrow involvement. This entity is derived from plasmocytoid dendritic cells and has a predilection for extranodal sites, especially the skin. Elderly male patients are the most affected and the prognostic is poor. The first case was reported in 1994 and sice then, single cases and a few small series have been published. This article presents the case of a previously healthy 56-years-old man, who presented himself to a skin eruption consisting in multiple, large dermal ulcerated tumors, located on the trunk and scalp. The lesions were painless and grew in size rapidly. Physical examination was normal except for the skin lesions. Histological examination of a biopsy specimen and immunohistochemical studies (positive for next markers: CD4, CD 45, CD56, CD68, Ki 67) revealed the rare diagnostic-blastic plasmacytoid dendritic cell neoplasm.

Pachydermodactyly--role of local corticotherapy.

Pachydermodactyly is a rare skin disease, defined as a benign form of digital fibromatosis. It is clinically characterized by painless hypertrophy of the skin around the proximal interphalangeal joints of the fingers, more common in males. This rare condition can affect both hands and is often associated with mechanical injury of the skin. Although there is no specific therapy, cessation of mechanical trauma associated with topical corticosteroid therapy can lead to satisfactory results. We present 3 sporadic cases of classical pachydermodactyly, anatomopathologically confirmed by the presence hyperkeratosis and acanthosis, which responded favorably to topically applied corticosteroids under occlusive dressings.

Chronic venous disease cases at the Iasi dermatology clinic.

UNLABELLED: Chronic venous disease (CVD) is defined as a disturbance of blood return to the deep venous system, superficial venous system, and communicating (perforating) veins. Once present, CVD persists throughout life, so like heart failure it is nowadays considered "a condition for life". Severe CVD of the lower limbs is one of the most common medical problems, affecting up to 25% of the general adult population of industrialized countries. AIM: to determine the incidence of CVD among the cases admitted to the Dermatology Clinic of the' "Sf. Spiridon" Emergency Clinical Hospital Iasi, CVD incidence by sex, age, area of residence and the main pathogens incriminated in super infection of ulcerative lesions. MATERIAL AND METHODS: We did a retrospective study of patients admitted to the Dermatology Clinic of the Iasi "Sf. Spiridon" Emergency Hospital over a five years period. RESULTS: Of the total number of patients admitted to our clinic (9375), 57% were diagnosed with CVD and 26.61% of them were with CEAP 6 class chronic venous insufficiency. There was an approximately equal sex distribution and most patients (44%) were older than 65 years. CONCLUSIONS: We did a large epidemiological study of venous disease, based on revised CEAP classification, showing again that it is not only a very important medical problem, with various clinical manifestation and multidisciplinary approach, but also an important issue for health insurance system.

Epidemiological and pathological aspects of skin cancer in North East of Romania.

UNLABELLED: In the last years skin cancer has become the most frequent cancer in humans, with the majority made up of two tumors: malignant melanoma (MM) and non-melanoma skin cancer (NMSC). AIM: To provide for the first time in the North East region of Romania, descriptive epidemiological data of melanoma and non-melanoma skin cancers. MATERIAL AND METHODS: We undertook a retrospective study over a five year period on the most frequent forms of skin cancer, basal cell carcinoma (BCC), squamous cell carcinoma (SCC) and MM, which included a total number of 1231 patients, hospitalized and treated in the Plastic Surgery Department of "St. Spiridon" Emergency Clinical Hospital, Iasi from 2008 until 2012. Results: BCC was diagnosed in a total of 675 patients, representing 54.9%. SCC was found in 217 patients, representing 17.6% and melanoma was diagnosed in 119 cases, a percent of 9.7% of the total number. The predominance of cutaneous malignancies waried with age, major site distribution was face and neck for BCC and SCC and the trunk for MM. RESULTS: This article describes the most common forms of skin cancer in our region, BCC (almost 55%), SCC (17.6%), and less in number MM (near to 10%); these results are similar to those published abroad in the last years. CONCLUSIONS: Future more elaborate interventional studies are necessary to identify the main risk factors in order to design the best preventive methods and, according to the skin cancer trend to specify the needs for dermatology network in our country.

[Demographic, clinical and laboratory characteristics of erisypelas in the period 2001-2010]. / Erizipelul--caracteristici demografice, clinice si paraclinice în perioada 2001-2010.

AIM: to describe demographic and clinical characteristics of erysipelas and to compare the sensitivity of two laboratory tests. MATERIAL AND METHODS: we studied patients with erysipelas hospitalized in the Dermatological Clinic between 2001 and 2010. RESULTS: the investigated 140 cases represented 8% of all skin infections hospitalized. Distribution of annual admissions has shown a gradual reduction in the number of admissions in the second half of the decade. A higher frequency was found in the second half of the year. Most patients were from rural areas (55%). The female gender predominated (69.3%). With few exceptions, the patients were adults averaging 59 years. The most common location was the lower leg (91.4%). Most clinical forms were mild and medium. Septic complications were absent. Recurrent erysipelas occurred in 5% of cases. Comorbidity included: chronic venous insufficiency (14.2%), hypertension (10%), obesity (8%), diabetes mellitus (5.7%) or chronic hepatitis (3.5%). CONCLUSIONS: the "benign" appearance of our cases is contrary to the trend rate of severe cases of cutaneous streptococcal infections in some western areas. From comparing laboratory tests results we observed their frequent mismatch. The ESR and the increase in percentage of polymorphonuclear neutrophils were more significant than the total number of leukocytes. Etiological therapy with penicillin G at a dose of 4 million UI/day was effective. The analysis allows the establishment of demographic and clinical features of erysipelas during the period and given territory.

Contact dermatitis - epidemiological study.

AIM: To evaluate the real incidence of contact dermatitis, to identify the most common allergens, the favoring factors, to establish the prophylaxis methods, the key for a correct management of the patient with contact dermatitis. METHOD: A retrospective study, on the patients that refers to the Dermatology Clinic, "St. Spiridon" Emergency Hospital Iasi, between 01.01.2006 and 31.12. 2009, based on demographic items, the type of contact dermatitis and the allergens implicated. RESULTS: we enrolled 353 patients between 2006-2009, representing 3,89% from the hospitalized patients; the study reveals a higher incidence at women (60,27%), similar with data from literature; the majority of the patients was aged over 45, with the higher rate in the interval of 45-65 years old; the most frequent implicated allergens and irritants were plants (26,31% - 92 patients) and topical drugs and antiseptics (25,65% - 89 patients); the area most affected was the face (25%) and the hands (19,07%), from which almost 80-90% was occupational dermatitis. The distribution of cases depending on the type of contact dermatitis indicates an approximate percentage of those allergic to those irritant. CONCLUSIONS: The real prevalence of this disease is unknown, being frequently a missed diagnosis (other kinds of eczema), the key of the correct diagnose being a repeated, exhaustive anamnesis, revealing all the favoring conditions and possible contact allergens.

[Clinico-epidemiological features and antimicrobial resistance pattern in gonococcal infection]. / Aspecte clinico-epidemiologice si particularitati ale sensibilitatii la antibiotice în infectia gonococica.

AIM: To analyze clinical and epidemiological features in patients with gonococcal infection attended Dermato-Venerology Clinic in Iasi and regional dermato-venerology offices and to evaluate gonococcal antimicrobial resistance pattern. METHODS: The study was carried out on 129 patients clinically diagnosed and bacteriologically confirmed with gonococcal infection who were subsequently submitted to a questionnaire. We studied their demographic characteristics (sex, age, nationality, marital status), clinical features (site of infection, symptoms, concurrent STI, previous history of gonorrhoea) and behavioral aspects (education, number and type of sexual partners, safe sexual practices). RESULTS: We found in our patients a strong association of gonorrhoea with young male individual, poor educational level and with clinical symptoms of urethritis. The level of antimicrobial resistance is higher than in other European countries. CONCLUSIONS: The poor health-seeking behavior, symptoms not specific enough, resistance pattern, lack of accessible and sensitive diagnostic methods lead to undiagnosed and probably mistreated gonorrhoea.

[Fungal infections and nail psoriasis]. / Infectiile fungice si psoriazisul unghial.

Onychomycosis and psoriasis are common diseases and it is possible that they coexist in the same patient. Psoriasis is a common cause of disturbance of the nail morphology. Nail disorders was reported in 10-80% of patients with psoriasis and may be associated with all clinical forms of disease. It has been suggested that the nail dystrophy in patients with psoriasis produce the lose of the natural protective barrier and increase vulnerability to fungal infections. But most authors report that in patients with psoriasis the prevalence of onychomycosis is no higher than in the general population. We conducted an observational analytical retrospective study of case report forms of patients with nail psoriasis hospitalized in Iasi Dermatology Clinic, 2004-2008. 360 patients were hospitalized with psoriasis. Of these 32 patients had nail disorders.

[Lichen planus-like eruption. Case report]. / Eruptie lichenoida postmedicamentoasa.

Cutaneous adverse drug reactions are among the most common adverse drug reactions. Thise reactions to drugs can comprise a broad spectrum of clinical and histopathological features, with an important capacity to mimic numerous dermatological diseases, making the diagnose very difficult. We present the case of a patient, under immunomodulating treatment (TNFalpha antagonist and leflunomide), with a muco-cutaneous lichen planus-like eruption.