Calcipotriol plus betamethasone dipropionate aerosol foam provides superior efficacy vs. gel in patients with psoriasis vulgaris: randomized, controlled PSO-ABLE study.

BACKGROUND: Fixed combination calcipotriol 50 µg/g (Cal) plus betamethasone 0.5 mg/g (BD) foam has been developed as a new treatment option for patients with psoriasis. METHODS: The randomized, parallel-group, investigator-blinded Phase III, 12-week PSO-ABLE study compared the efficacy and safety of Cal/BD foam with Cal/BD gel. Patients aged ≥18 years with mild-to-severe psoriasis were randomized 4:4:1:1 to once-daily Cal/BD foam, Cal/BD gel, foam vehicle or gel vehicle (NCT02132936). The primary efficacy endpoint was the proportion of patients who were clear/almost clear with a ≥ 2 grade improvement according to the physician's global assessment of disease severity (i.e. treatment success) at week 4 for Cal/BD foam vs. week 8 for Cal/BD gel. Secondary efficacy endpoints included: proportion of patients achieving at least a 75% reduction in modified psoriasis area and severity index (mPASI75), and time to treatment success (TTTS). Safety was monitored throughout. RESULTS: A total of 463 patients were randomized: Cal/BD foam (n = 185), Cal/BD gel (n = 188), foam vehicle (n = 47), gel vehicle (n = 43); overall completion rate was 90%. Cal/BD foam achieved higher treatment success rates (38% vs. 22%; P < 0.001) and mPASI75 (52% vs. 35%; P < 0.001) by week 4 than Cal/BD gel by week 8. Median TTTS with Cal/BD foam was 6 weeks; this could not be determined for Cal/BD gel as 50% treatment success was not achieved (P < 0.001). Adverse drug reactions were reported in 14 (7.6%) Cal/BD aerosol foam patients and 7 (3.7%) Cal/BD gel patients; all were single events except for itch with Cal/BD aerosol foam (n = 5; 2.7%) and worsening psoriasis with Cal/BD gel (n = 3; 1.6%). CONCLUSION: Cal/BD aerosol foam showed significantly greater efficacy after 4 weeks, than 8 weeks of treatment with Cal/BD gel, with similar tolerability.

The management of psoriasis in children and adolescents.

The onset of psoriasis in childhood is common. As many as forty percent of adult patients with psoriasis have reported manifestations of this condition in childhood, with at least one-third of patients demonstrating features of psoriasis before the age of 16.1 The psychosocial impairment, in addition to the physical affliction that can result from psoriasis is a reminder that early recognition and management of psoriasis in children and adolescents is crucial. Several recent studies have investigated the use of standard psoriasis therapies in children with psoriasis, including topical treatments, phototherapy, and systemic therapies. The inflammatory nature of psoriasis has also prompted further study of the use of biologic therapeutics in children, where targeted treatments may offer a safer option. This review will discuss current options available for the management of childhood and adolescent psoriasis.

Gadolinium-induced nephrogenic systemic fibrosis in a patient with an acute and transient kidney injury.

Nephrogenic systemic fibrosis (NSF) describes a characteristic fibrosing disorder which typically presents with indurated plaques on the trunk and extremities of patients with advanced renal disease. We present a case of biopsy-confirmed NSF in a patient with severe acute kidney injury with no prior history of renal disease. A 64-year-old man with an acute and severe decrease in glomerular filtration rate underwent magnetic resonance imaging studies with gadolinium contrast (Omniscan) and subsequently developed NSF. His renal disease had normalized at the time his skin disease developed. Skin biopsies revealed findings of NSF and scanning electron microscopy with energy-dispersive X-ray spectroscopy confirmed insoluble gadolinium within lesional tissue.

Granular cell dermatofibroma. A benign tumor that can simulate malignancy.

We report on an unusual dermatofibroma with granular cells. The dermatofibroma contained mitotic figures raising a differential diagnosis that included malignant granular cell tumor. Granular cell dermatofibroma is an uncommon variant, but one that clinicians and surgeons should become aware of to ensure accurate diagnosis.

Evaluation of halobetasol propionate ointment in the treatment of plaque psoriasis: report on two double-blind, vehicle-controlled studies.

The results of two studies are presented that reveal the efficacy and safety of 0.05% halobetasol ointment in the treatment of patients with plaque psoriasis of at least moderate severity. Both multicenter studies were randomized, double-blind, and vehicle controlled, and study medications were applied twice daily for 2 weeks. One study was a paired-comparison (PC); the other study was of parallel-group (PG) design. Both studies called for evaluations at entry (week 0) and after 1 and 2 weeks of treatment. The PC study enrolled 100 patients; the PG study enrolled 110 patients; 204 patients provided efficacy data over both studies. In the PC study, plaque elevation, erythema, and scaling, at least moderately severe at entry, showed at the end of treatment both statistical (p less than or equal to 0.0003) and clinical significance (all greater than 1-unit difference on the rating scale) favoring 0.05% halobetasol ointment over vehicle. Pruritus (initially mild) and total score also showed statistically significant treatment differences favoring halobetasol at the final evaluation. Patient global responses for "effectiveness" and "overall rating" favored 0.05% halobetasol ointment over vehicle. In the PG study, induration, erythema, and scaling, at least moderately severe at entry, showed at the end of treatment both statistically and clinically significant differences favoring 0.05% halobetasol ointment over vehicle. Physician's global evaluation favored 0.05% halobetasol ointment over vehicle after 2 weeks of use. No patients were released from either study because of adverse events. No systemic adverse events or findings of skin atrophy were reported in these studies. Reports of "stings" or "burns" were equally divided between halobetasol and its vehicle.(ABSTRACT TRUNCATED AT 250 WORDS)

Persistent light reaction to hexachlorophene.

The first patient with what appears to be persistent light reaction caused by hexachlorophene alone is reported. Persistent light reaction may occur in patients with milder degrees of photosensitivity, and appropriate photopatch testing should be performed.

The safety of halobetasol 0.05% ointment in the treatment of psoriasis.

The effects on the hypothalamic-pituitary-adrenal axis of the ultra-high potency corticosteroid halobetasol in the treatment of psoriasis were evaluated in seven patients with extensive, long-standing plaque psoriasis. Each patient applied 3.5 g halobetasol 0.05% ointment in the morning and evening for 7 days. Morning plasma cortisol levels and 24-hour urinary excretion of 17-hydroxycorticosteroid were determined before and on the last 2 days of treatment; plasma cortisol levels were also determined 4 and 5 days after completion of therapy. Morning plasma cortisol concentrations did not decrease significantly during treatment, and no values were below the normal range. Mean 24-hour urinary 17-hydroxycorticosteroid excretion fell from 6.6 +/- 1.4 mg to 5.1 +/- 1.4 mg. Two patients had mild, localized pruritus and stinging with the initial ointment application. No other adverse cutaneous effects were observed. Halobetasol was also clinically efficacious over the 7 days of treatment, based on evaluation of pruritus, erythema, scaling, and plaque elevation. These results demonstrate no adverse effects of the drug on the hypothalamic-pituitary-adrenal axis at doses that are clinically effective in the management of plaque psoriasis.

Penile encrustation due to a condom catheter.

We report a 68-year-old man with penile encrustation caused by a condom catheter used for urinary incontinence. High-resolution x-ray crystallographic analysis of the encrustation revealed struvite [MgNH4PO4.6H2O] and apatite [Ca5(PO4)3(OH)]. Physicians should be aware that penile encrustation may occur as a complication of condom catheter use. The problem of encrustation is discussed. A brief review of condom catheter complications is presented.

Allergic contact dermatitis from bacitracin.

Bacitracin is a commonly used topical antibiotic. Although occasional reports of adverse reactions to bacitracin have appeared in the medical literature, it is considered to be a nonsensitizing agent by most dermatologists. A description of two patients who demonstrated allergic contact dermatitis from bacitracin is presented, with a review of the pertinent literature.

Recurrent cutaneous vasculitis in cystic fibrosis.

We treated a patient with cystic fibrosis who experienced recurrent episodes of palpable purpura and arthralgias associated with exacerbations of her pulmonary disease. Skin biopsy demonstrated the classic findings of leukocytoclastic vasculitis, and C3 deposits were detected in the dermal blood vessels. Chronic bacterial infection and antibiotics are possible sources of antigen involved in immune complex formation in patients with chronic lung diseases.

The association of aplasia cutis congenita with therapy of maternal thyroid disease.

Aplasia cutis congenita, the localized absence of skin at birth, usually is an isolated scalp defect. We examined an infant with aplasia cutis congenita associated with maternal Grave's disease and the use of methimazole during pregnancy. This association was reported twice before. It has certain implications with respect to therapy of pregnant hyperthyroid women.

Ectodermal defects and chronic mucocutaneous candidiasis in idiopathic hypoparathyroidism.

Idiopathic hypoparathyroidism is a rare disorder produced by parathyroid hormone deficiency of unknown cause. It is often associated with other endocrine abnormalities. Patients with idiopathic hypoparathyroidism frequently develop ectodermal disease, including dry, rough skin: coarse, brittle hair; and lusterless, distally split nails. All of these complaints are relatively common in a dermatologic practice. Chronic mucocutaneous candidiasis is also a manifestation of idiopathic hypoparathyroidism. A patient is presented with a prominent ectodermal dysplasia and a chronic mucocutaneous candidiasis that were due to the underlying idiopathic hypoparathyroidism. A brief review of idiopathic hypoparathyroidism is included, as well as the implications of this diagnosis in terms of differential diagnosis, associated endocrine disorders, and therapy.

Pustular eruption following administration of cephradine.

We report the case of an unusual generalized pustular drug eruption caused by the cephalosporin cephradine. Previously reported pustular drug reactions are briefly reviewed. We suggest that a reaction to an administered drug should be considered in the differential diagnosis when a patient presents with fever and a diffuse pustular eruption.

Chronic perianal herpes simplex in immunocompromised hosts.

Four immunosuppressed patients are described with chronic ulcerative herpes simplex virus infection in the sacral and perianal area. Three of these patients were evaluated for decubitus ulcers. Prompt diagnosis was possible when the characteristic morphologic features were recognized and when viral culture and Tzanck smear specimens were obtained. Previously reported cases are reviewed as well. Chronic mucocutaneous herpes simplex infections are complications of immunocompromised hosts and should be recognized early if appropriate therapy is to be initiated.

Avascular necrosis of bone in dyskeratosis congenita.

A case of dyskeratosis congenita, a rare X-linked disorder, is presented. The patient had the classic triad of cutaneous findings: reticulated hyperpigmentation, nail dystrophy, and leukoplakia. In addition, a previously unreported finding developed, avascular necrosis of bone without systemic steroid therapy. Recognition of this disorder is important because pancytopenia and malignancy develop in up to 50 percent of patients.

Cutaneous metastases from chondrosarcoma.

This report describes a patient with histologically confirmed multiple cutaneous metastases from a skeletal chondrosarcoma and reviews the two previously published cases of this very unusual pattern of metastasis. We conclude that metastatic chondrosarcoma should be considered in the differential diagnosis of multiple cartilaginous tumors of the skin, and that radiotherapy may play a role in the management of metastatic chondrosarcoma.

Stevens-Johnson syndrome due to Mycoplasma pneumoniae in an adult.

A case of Stevens-Johnson Syndrome (erythema multiforme major) due to Mycoplasma pneumoniae infection in a 45-year-old man is presented. This association has been previously reported only in children and young adults. A brief review of erythema multiforme, including the Stevens-Johnson syndrome, is described. M. pneumoniae should be added to the list of causes of the Stevens-Johnson syndrome in adults with pneumonia.