A Study of the Safety and Efficacy of Calcipotriol and Betamethasone Dipropionate Scalp Formulation in the Long-Term Management of Scalp Psoriasis

Luger, Thomas A.; Cambazard, F.; Larsen, Finn Breinholt; Bourcier, Marc; Gupta, Girish; Clonier, F.; Kidson, Paul Andrew; Shear, Neil H.

doi:10.1159/000155642

Cited by 81 publications

(126 citation statements)

References 38 publications

(22 reference statements)

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“…The efficacy and safety of the fixed combination of calcipotriol 50 μg/g (Cal) and betamethasone 0.5 mg/g as dipropionate (BD) has been confirmed in long‐term trials 16, 17, 18, 19. The ointment and gel formulations of this fixed combination are established first‐line treatments 20.…”

Section: Introductionmentioning

confidence: 99%

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

Paul

Gold

Cambazard

et al. 2016

Acad Dermatol Venereol

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102

168

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BackgroundFixed 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.MethodsThe 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.ResultsA 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%).ConclusionCal/BD aerosol foam showed significantly greater efficacy after 4 weeks, than 8 weeks of treatment with Cal/BD gel, with similar tolerability.

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Section: Introductionmentioning

confidence: 99%

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

Paul

Gold

Cambazard

et al. 2016

Acad Dermatol Venereol

Self Cite

102

168

View full text Add to dashboard Cite

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“…9 A 52-week double-blind safety trial included efficacy as a secondar y endpoint. 10 The published trial 9 was a double-blind comparison of Xamiol with betamethasone, calcipotriol (both in the gel vehicle) or vehicle alone in 1505 adults, most of whom had moderate-to-severe psoriasis extending over up to half of the scalp with a mean duration of approximately 15-17 years. Other treatments were not allowed.…”

Section: Clinical Trialsmentioning

confidence: 99%

“…8 An unpublished trial in 312 patients with moderately severe scalp psoriasis compared Xamiol once daily with calcipotriol scalp solution twice daily; after eight weeks, the proportions of patients with absent or very mild disease were 69 and 31 per cent respectively. 8 In the one-year study, 10 869 patients with scalp psoriasis of at least moderate severity affecting at least 10 per cent of the scalp were randomised to treatment with Xamiol or calcipotriol 50µg per g in the same vehicle. Other topical scalp treatments and systemic treatments were not allowed.…”

Section: Clinical Trialsmentioning

confidence: 99%

“…10 Uncommon adverse reactions include burning sensation, skin pain or irritation, folliculitis, dermatitis, erythema, acne, dry skin, exacerbation of psoriasis, rash, pustular rash and eye irritation. 8 The frequency of these adverse reactions does not appear to increase with treatment for up to one year.…”

Section: Adverse Effectsmentioning

confidence: 99%

“…8 The frequency of these adverse reactions does not appear to increase with treatment for up to one year. 10 …”

Section: Adverse Effectsmentioning

confidence: 99%

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