Safety and efficacy of fixed-dose combination calcipotriol (50 µg/g) and betamethasone dipropionate (0.5 mg/g) cutaneous foam in adolescent patients (aged 12 to <17 years) with plaque psoriasis: results of a phase II, open-label trial.

BACKGROUND: Fixed-dose combination of calcipotriol (50 µg/g; Cal) and betamethasone dipropionate (0.5 mg/g; BD) foam is approved for plaque psoriasis treatment in adults, with a paucity of data supporting use in adolescents. OBJECTIVES: To evaluate safety of 4 weeks' treatment with Cal/BD foam in adolescent patients with psoriasis, and additional safety outcomes in patients with more severe disease (HPA-axis cohort). Primary objectives included treatment-emergent adverse events (TEAEs) and systemic calcium levels in the overall population, and HPA-axis function, change in calcium excretion and the calcium:creatinine ratio in the HPA-axis cohort. Secondary objectives included exploratory efficacy endpoints [treatment success: change in Psoriasis Area and Severity Index (PASI)]. Systemic exposure to Cal/BD was also assessed. METHODS: A phase II, open-label, study (NCT02387853) in patients (12 to <17 years) with at least mild psoriasis, to evaluate Cal/BD foam applied once daily for ≤4 weeks. RESULTS: In patients assigned to treatment (n = 106), 32 TEAEs occurred in 22 patients (20.8%). All but two TEAEs were mild; none led to study withdrawal or death. Changes (0-4 weeks) in albumin-corrected serum calcium (overall population) and urinary calcium excretion (HPA-axis cohort) were small, transient and not considered clinically relevant. In the HPA-axis cohort, no change in urinary calcium:creatinine ratio was observed and responses to adrenocorticotropic-hormone (ACTH) challenge did not suggest disruption of the HPA-axis. Prespecified treatment success on the body and scalp was achieved by 71.8% and 75.7% of the overall population, respectively. Mean PASI decreased by 82.0% vs. baseline at Week 4. Systemic exposure to Cal/BD was minimal. CONCLUSIONS: Cal/BD foam was well tolerated in adolescent patients with body/scalp psoriasis. There was no evidence for dysregulation of the HPA-axis nor calcium homoeostasis in patients with more severe disease. Exploratory efficacy data in the overall population were encouraging.

Secukinumab demonstrates greater sustained improvements in daily activities and personal relationships than ustekinumab in patients with moderate-to-severe plaque psoriasis: 52-week results from the CLEAR study.

BACKGROUND: Psoriasis can greatly impact patients' lives by influencing clothing worn as well as by impairing sexual functioning. Secukinumab, a human monoclonal antibody selectively neutralizing interleukin-17A, has demonstrated good efficacy and safety in the treatment of moderate-to-severe psoriasis and psoriatic arthritis with a rapid onset of action and sustained response. OBJECTIVE: This analysis using the CLEAR study, a phase 3b double-blind study comparing the efficacy and safety of secukinumab vs. ustekinumab in adults with moderate-to-severe plaque psoriasis, evaluated the treatment effects on patient's daily activities and personal relationships. METHODS: Impact on daily activities (interference with home/shopping/garden, and influence on clothes worn) and impact on personal relationships (problems with partner/others, and sexual difficulties) as well as their corresponding subscales were selected from the Dermatology Life Quality Index scale and evaluated for patients treated with secukinumab vs. ustekinumab from the CLEAR study. Treatment differences in mean scores and proportions of responders (score = 0, indicating no impact) were evaluated through 52 weeks. Time to response was evaluated through Week 16. RESULTS: Significant differences between secukinumab and ustekinumab were observed for daily activities and personal relationships at Week 16 and sustained through Week 52 (Week 52 response rates for daily activities: 82.9% vs. 73.5%, including interference with home/shopping/garden: 88.5% vs. 78.2%, and influence on clothes worn: 85.6% vs. 74.4%; personal relationships: 86.1% vs. 73.7%, including problems with partner/others: 86.6% vs. 74.8%, and sexual difficulties: 88.5% vs. 74.3%; all P < 0.01). The median time to response was 4 weeks for secukinumab vs. 8 weeks for ustekinumab for daily activities and personal relationships (both P < 0.05). CONCLUSION: Secukinumab treatment helps patients with moderate-to-severe plaque psoriasis have a more normal life faster when compared to ustekinumab, by providing greater and sustained improvement in clothing choice and sexual functioning.

Efficacy of tofacitinib in treatment of alopecia universalis in two patients.

BACKGROUND: Autoimmune-triggered non-scarring hair loss is a feature of alopecia areata (AA). Initially patchy and often self-limited, severe hair loss forms include the complete loss of scalp hair or alopecia totalis (AT) and complete loss of all hair or alopecia universalis (AU). For AT and AU a reliable treatment has remained elusive. The targeted kinase inhibitor tofacitinib, in current use for treatment of other immune diseases, has been hypothesized as a viable option for AA, AT and AU therapy and a few case reports support this. OBJECTIVE: Our study aims to provide evidence for the effectiveness of tofacitinib in the treatment of AU. METHODS: Two patients diagnosed with long-term AU were prescribed tofacitinib citrate at a dosage of 5 mg twice daily and observed for eight months. RESULTS: In the first patient, beard growth was significant by 3 months of treatment. By 6 months of treatment, hair growth was apparent throughout the entire body. By 8 months of treatment, scalp hair continued to grow longer and thicker. In addition, eyelashes and eyebrows were established. In the second patient, a noticeable increase in scalp hair was present just 1 month into treatment. By 4 months into treatment, significant scalp regrowth was observed as well as eyelash, eyebrow and beard regrowth. Axillary hair regrowth and isolated leg hair was noted by 8 months. CONCLUSION: In our patients, tofacitinib successfully alleviated AU in the absence of significant adverse side-effects. We recommend that further study be required to establish safety and confirm efficacy.

Tazarotene cream versus adapalene cream in the treatment of facial acne vulgaris: a multicenter, double-blind, randomized, parallel-group study.

A multicenter, double-blind, randomized, parallel-group trial compared tazarotene 0.1% cream with adapalene 0.1% cream, once daily for 12 weeks, in 173 patients with facial acne vulgaris. Tazarotene was associated with a significantly greater incidence of patients achieving 50% or greater global improvement (77% vs. 55%, P < or = .01), and a significantly greater reduction in comedo count (median of 68% vs. 36%, P < or =.001, compared with adapalene. A significant between-group difference in baseline inflammatory lesion count precluded a comparison of efficacy against inflammatory acne. The most common adverse events were dryness, peeling/flaking, itching, redness/erythema, burning, and facial irritation with comparable incidences of each between groups. Mean peeling and burning levels were milder with adapalene, though were trace or less in both groups throughout. There were no significant between-group differences in the incidence of patients discontinuing due to lack of efficacy or adverse events. Tazarotene cream offers significantly greater efficacy and comparable tolerability to adapalene cream.

Autosomal recessive ectodermal dysplasia: I. An undescribed dysplasia/malformation syndrome.

We describe 27 individuals of 7 families related to each other with high probability who showed manifestations of ectodermal dysplasia and other anomalies affecting females as severely as males with variable expressivity. All parents were normal. These families were detected in a relatively isolated and inbred population with very small neighbouring communities from a Caribbean Sea island, Margarita Island, in Northeastern Venezuela (Nueva Esparta State). The clinical picture common to all patients could not be classified within the heterogeneous group of known ectodermal dysplasias and the published cases do not resemble our patients. We believe that this condition constitutes a newly recognized autosomal recessive dysplasia/malformation syndrome of ectodermal dysplasia.

A report of two patients with lichen aureus.

Two patients with lichen aureus are described. The clinical and histologic features of our patients were compared with previously reported cases of lichen aureus in an effort to classify this entity properly among the pigmented purpuric dermatoses. We regard lichen aureus as a distinct entity. Although this disorder has been described principally in adult patients it began at the age of 14 years in one of our patients.

Sebum, cosmetics, and skin care.

Recent contributions to the understanding of the physiology and biochemistry of sebum production and of the lipids on the skin surface are leading to the development of effective strategies to regulate excessive sebum production and its consequences through the use of cosmetics and skin care products.

Cyclosporine and tacrolimus in dermatology.

Immune modulators are being used with increasing frequency in dermatology. This article reviews two such agents, cyclosporine and tacrolimus. Discussion emphasizes the pharmacology, side effects, and uses of these two drugs in dermatologic disorders.

Trichotillomania in adults.

The cause of hair plucking is purely psychological. The extent of the hair plucking and the area from which the hair is plucked seem to have no direct correlation with the patient's underlying psychopathologic behavior. Hair plucking that begins in childhood and extends into adolescence and adulthood may represent a more complex psychopathologic condition. Therapy can consist of confronting the patient with his behavior and helping him cope with the triggering stressful external causes. Psychiatric consultation is suggested if this is not helpful. Trichotillomania by definition implies psychosis. Since this behavior is seldom associated with psychosis, we suggest the term hair plucking be used to describe this syndrome. Herein, we present two cases of trichotillomania (hair plucking), review of the relevant literature dealing with the psychopathologic nature of this disorder, and suggest methods for managing these patients.

Multiple agminated pigmented Spitz nevi (mimicking acral lentiginous malignant melanoma and dysplastic nevus) in an African-American girl.

BACKGROUND: Reed's nevi are distinguished from Sptiz tumors by their significant melanogenesis and growth pattern. They may be confused with melanoma on clinical and histologic grounds. CASE REPORT: An unusual case in which multiple agminated Reed's nevi mimicked acral lentiginous malignant melanoma in an African-American girl is presented. A critical review of the literature is presented to assist in the diagnosis. CONCLUSIONS: Awareness of this entity and of its possible clinical presentations and judicious application of conventional hematoxylin-eosin microscopic criteria remain the most useful methods to bring the correct diagnosis in most instances. Mutilating or excessive surgery may be avoided for most cases of pigmented spindle and epithelioid cell nevus.

Ultrasound-guided thermocouple placement for cryosurgery.

BACKGROUND: Although cryosurgical methods have high cure rates, imprecise estimates of both skin lesion depth and destructive temperature front location result in subjective technique in skin malignancy treatments. OBJECTIVE: We evaluated the possibility of newer ultrasound equipment to assist in the precise placement of thermocouples in human skin. METHODS: DermaScan C ver. 3 ultrasonographic equipment fitted with a sharp focus probe with a frequency of 20 MHz and a scan length of 12.1 mm was used to locate thermocouples with 27- and 30-gauge needles. RESULTS: We successfully and reproducibly located thermocouples and thin needles, and accurately measured their distance from the skin surface. CONCLUSION: Ultrasound is a useful method for the accurate placement of thermocouples, and needles as thin as 30 gauge for monitoring in cryosurgery.

Coexistence of lichen planus and systemic lupus erythematosus.

Three cases of the simultaneous occurrence of lichen planus (LP) and systemic lupus erythematosus (SLE) are presented. Each patient had clinical, histologic, and immunopathologic LP. Additionally, each patient had clinical SLE that fulfilled the American Rheumatism Association criteria for the diagnosis of SLE. The clinical manifestations of SLE were predominantly cutaneous. The three patients had positive lupus band test and high titers of antinuclear antibodies. One patient had vitiligo in addition to SLE and LP. LP and SLE have common clinical, histologic, and immunopathologic features. It is possible that a common agent (or agents) may cause either disease or the overlap syndrome, depending on the immunogenetic predisposition of the patient.

A zinc-deficiency dermatitis in patients on total parenteral nutrition.

Three patients on home total parenteral nutrition utilizing a synthetic amino acid solutions developed a dermatitis consistent with acrodermatitis enteropathica after 30, 43 and 62 days of therapy. The dermatitis resolved after changing to casein hydrolysate in 2 patients and after full oral alimentation in the third. Although measured serum zinc levels were repeatedly normal to elevated in all patients, sufficient retrospective data analysis combined with literature review on this subject, clearly implicates zinc deficiency as the etiology for their dermatitis. Adequate zinc supplementation of synthetic amino acid solutions is essential in order to avoid this complication.

Dermatofibrosarcoma non-protuberans: description and report of five cases of a morpheaform variant of dermatofibrosarcoma.

Five cases of dermatofibrosarcoma are reported. All showed features typical of dermatofibrosarcoma protuberans except that in four cases, and a portion of the fifth case, no protusion of the tumor was noted clinically despite the rather advanced stage of growth of the tumor. These lesions resembled morphea or a morpheaform basal cell carcinoma clinically but could be recognized as "dermatofibrosarcoma non-protuberans" by physicians who had observed a previous case.