An open-label study assessing the safety and efficacy of alitretinoin in patients with severe chronic hand eczema unresponsive to topical corticosteroids

Dirschka, Thomas; Reich, Kristian; Bissonnette, Robert; Maares, J.; Brown, Thomas C.; Diepgen, Thomas L.

doi:10.1111/j.1365-2230.2010.03955.x

Cited by 30 publications

(39 citation statements)

References 9 publications

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“…The safety findings in TOCCATA were consistent with those in previous clinical trials (15)(16)(17)22), and confirmed the tolerability profile of alitretinoin. The most common treatment-emergent adverse reaction was headache (7.5%), followed by increased triglycé-rides and increased cholesterol.…”

Section: Discussionsupporting

confidence: 89%

“…In the clinical development programme for registration, studies of up to 6 months' duration with alitretinoin have shown that it is highly effective in the treatment of severe CHE unresponsive to potent topical corticosteroids and is well tolerated with a good safety profile (15)(16)(17). Alitretinoin was initially granted approval by several European authorities, including the German Health Authorities in autumn 2008, for the treatment of patients with severe CHE unresponsive to potent topical corticosteroids.…”

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confidence: 98%

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Efficacy and Tolerability of Alitretinoin for Chronic Hand Eczema Under Daily Practice Conditions: Results of the TOCCATA Open Study Comprising 680 Patients

Diepgen¹,

Pfarr²,

Zimmermann³

2012

Acta Derm Venerol

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This non-interventional observational open study (TOCCATA, sponsored by Basilea Pharmaceutica Germany) investigated the use of alitretinoin to treat chronic hand eczema under daily "real life" medical practice conditions in Germany. A total of 349 dermatologists through-out Germany enrolled 680 adult patients with chronic hand eczema. Patients were prescribed and treated with alitretinoin in accordance with the summary of product characteristics. The maximum observation duration was 24 weeks, with efficacy and safety parameters evaluated every 4 weeks. Efficacy was primarily evaluated by assessing disease severity according to the Physician Global Assessment. In total, 56.7% of patients achieved a Physician Global Assessment rating of "clear" or "almost clear" hands, with only small differences in patients with different morphological forms: hyperkeratotic-rhagadiform (59.2%), fingertip (52.2%) and vesicular (47.9%). This observational study demonstrates the effectiveness and tolerability of alitretinoin in everyday clinical practice in addition to the known efficacy and safety obtain-ed by randomized controlled clinical trials.

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Section: Discussionsupporting

confidence: 89%

mentioning

confidence: 98%

Efficacy and Tolerability of Alitretinoin for Chronic Hand Eczema Under Daily Practice Conditions: Results of the TOCCATA Open Study Comprising 680 Patients

Diepgen¹,

Pfarr²,

Zimmermann³

2012

Acta Derm Venerol

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“…However, chronic topical treatment is associated with a number of side effects [92]. Skin corticosteroid depot formation contributes to the local toxicity associated with these products, and is a consequence of the slow permeation of these drugs from the SC into the epidermis [93,94].…”

Section: Potential Applicationsmentioning

confidence: 99%

Spray-on transdermal drug delivery systems

Ibrahim

2014

Expert Opinion on Drug Delivery

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TSS is easily applied, delivering flexible drug dosage and associated with lower incidence of skin irritation. TSS provides a fast-drying product where the volatile solvent enables uniform drug distribution with minimal vehicle deposition on skin. TSS ensures precise dose administration that is aesthetically appealing and eliminates concerns of residual drug associated with transdermal patches. Furthermore, it provides a better alternative to traditional transdermal products due to ease of product development and manufacturing.

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“…The DLQI consists of 10 items: (1) itching and scratching, (2) embarrassment, (3) housework, (4) dressing, (5) social relationships/spare time, (6) sport, (7) work/study, (8) partner/relatives, (9) sex, and (10) treatment. Each question relates to the last week, and ranges from 0 (no impairment) to 3 (maximum impairment).…”

Section: Datamentioning

confidence: 99%

Cost and quality of life in patients with severe chronic hand eczema refractory to standard therapy with topical potent corticosteroids

Cortesi

Scalone

Belisari³

et al. 2013

Contact Dermatitis

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An open-label study assessing the safety and efficacy of alitretinoin in patients with severe chronic hand eczema unresponsive to topical corticosteroids

Abstract: Oral alitretinoin 30 mg was well tolerated and effective, and provided distinct therapeutic benefits in severe CHE, as assessed by patients.

Cited by 30 publications

References 9 publications

Efficacy and Tolerability of Alitretinoin for Chronic Hand Eczema Under Daily Practice Conditions: Results of the TOCCATA Open Study Comprising 680 Patients

Efficacy and Tolerability of Alitretinoin for Chronic Hand Eczema Under Daily Practice Conditions: Results of the TOCCATA Open Study Comprising 680 Patients

Spray-on transdermal drug delivery systems

Cost and quality of life in patients with severe chronic hand eczema refractory to standard therapy with topical potent corticosteroids

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