An investigator-initiated, double-blind, vehicle-controlled pilot study: Assessment for tachyphylaxis to topically occluded halobetasol 0.05% ointment in the treatment of psoriasis

Czarnowicki, Tali; Linkner, Rita V.; Suárez‐Fariñas, Mayte; Ingber, A; Lebwohl, Mark

doi:10.1016/j.jaad.2014.05.040

Cited by 10 publications

(8 citation statements)

References 19 publications

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“…Medication vacation periods may be helpful [19]. Czarnowicki et al [20] show that psoriasis plaques re-exposed to halobetasol ointment after a vacation period demonstrate greater improvement than plaques not previously exposed to halobetasol. Switching between different medications in the same class allows for an individual medication vacation period while at the same time continuing to treat a condition.…”

Section: Discussionmentioning

confidence: 99%

Conversion back to bevacizumab or ranibizumab for recurrent neovascular activity with aflibercept in age-related macular degeneration: a case series

et al. 2016

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BackgroundNeovascular age-related macular degeneration often requires chronic therapy with anti-VEGF agents, and patients with recurrent disease are challenging to manage.MethodsThis retrospective case series evaluates patients who were switched from bevacizumab or ranibizumab to aflibercept and then back again because of recurrent fluid on optical coherence tomography (OCT) by reporting changes in OCT measurements over the course of medication changes.ResultsTwenty-one eyes in nineteen patients received an average of 20.7 bevacizumab and/or ranibizumab injections and then an average of 7.2 aflibercept injections before being switched back to bevacizumab or ranibizumab because of recurrent fluid on OCT. Median central macular thickness improved on transition from bevacizumab or ranibizumab (317 μm) to aflibercept (285 μm; p = 0.034), then worsened over the course of aflibercept treatment (296 μm; p = 0.080), but improved again with transition from aflibercept back to bevacizumab or ranibizumab (283 μm; p = 0.016). The total volume of subretinal fluid, intraretinal fluid, and pigment epithelial detachments also decreased on transition from bevacizumab or ranibizumab (2.56 mm3) to aflibercept (2.44 mm3; p = 0.080), then worsened over the course of aflibercept treatment (3.18 mm3; p = 0.019), and improved again on transition back to bevacizumab or ranibizumab (2.11 mm3; p = 0.016).ConclusionsWhile aflibercept appears initially effective, some patients develop recurrent fluid with aflibercept that improves with transition back to bevacizumab or ranibizumab. Rotating anti-VEGF agents may be beneficial with recurrent neovascular activity.

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Section: Discussionmentioning

confidence: 99%

Conversion back to bevacizumab or ranibizumab for recurrent neovascular activity with aflibercept in age-related macular degeneration: a case series

et al. 2016

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“…The lack of access to the baseline photographs during the live patient assessments in the phase III trials may have inflated the results for vehicle. Improvements with vehicle treatment have been a documented limitation of randomized controlled clinical trials investigating new drugs for dermatological diseases, including rosacea . Raters, blinded to the study treatment, may seek out the expected effects of the active drug treatment from the vehicle treatment, artificially identifying a response to vehicle where none exists .…”

Section: Discussionmentioning

confidence: 99%

Use of an alternative method to evaluate erythema severity in a clinical trial: difference in vehicle response with evaluation of baseline and postdose photographs for effect of oxymetazoline cream 1·0% for persistent erythema of rosacea in a phase IV study

Eichenfield

Rosso²,

Tan

et al. 2019

British Journal of Dermatology

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SummaryBackgroundOnce‐daily topical oxymetazoline cream 1·0% significantly reduced persistent facial erythema of rosacea in trials requiring live, static patient assessments.ObjectivesTo evaluate critically the methodology of clinical trials that require live, static patient assessments by determining whether assessment of erythema is different when reference to the baseline photograph is allowed.MethodsIn two identically designed, randomized, phase III trials, adults with persistent facial erythema of rosacea applied oxymetazoline or vehicle once daily. This phase IV study evaluated standardized digital facial photographs from the phase III trials to record ≥ 1‐grade Clinician Erythema Assessment (CEA) improvement at 1, 3, 6, 9 and 12 h postdose.ResultsAmong 835 patients (oxymetazoline n = 415, vehicle n = 420), significantly greater proportions of patients treated with oxymetazoline vs. vehicle achieved ≥ 1‐grade CEA improvement. For the comparison between phase IV study results and the original phase III analysis, when reference to baseline photographs was allowed while evaluating post‐treatment photographs, the results for oxymetazoline were similar to results of the phase III trials (up to 85.7%), but a significantly lower proportion of vehicle recipients achieved ≥ 1‐grade CEA improvement (up to 29.7% [phase 4] vs. 52.3% [phase 3]; P<0.001). In the phase IV study, up to 80·2% of patients treated with oxymetazoline achieved at least moderate erythema improvement vs. up to 22·9% of patients treated with vehicle. The association between patients’ satisfaction with facial skin redness and percentage of erythema improvement was statistically significant.ConclusionsAssessment of study photographs, with comparison to baseline, confirmed significant erythema reduction with oxymetazoline on the first day of application. Compared with the phase III trial results, significantly fewer vehicle recipients attained ≥ 1‐grade CEA improvement, suggesting a mitigated vehicle effect. This methodology may improve the accuracy of clinical trials evaluating erythema severity.

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“…Tachyphylaxis with long-term use of topical corticosteroids is a debated issue in psoriasis. Whilst there is evidence that topical corticosteroids do not lose efficacy with continued use (66)(67)(68), some healthcare professionals have concerns that patients can become tolerant to treatment. To help address these concerns, efficacy and safety data for long-term topical use are needed, as well as educational programs that counteract misinformation.…”

Section: Tachyphylaxismentioning

confidence: 99%

Long-term topical management of psoriasis: the road ahead

Segaert

Calzavara‐Pinton

Cueva

et al. 2020

Journal of Dermatological Treatment

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Topical therapies have been available for the treatment of psoriasis for several decades. Despite this and the availability of several types of topicals, with varying potency, and numerous vehicles of administration, the majority of clinical data and guidance is on short-term use in the management of psoriasis. The aim of this manuscript is to review the unmet needs that exist in the long-term management of psoriasis and provide the dermatology community with an understanding that a treatment regimen with topical therapies could be the best treatment option at least for some phases of this chronic relapsing disease. We present a 'call to action' on the need for clinical alignment on terminology in the field and recommend the term 'long-term management' be adopted as the most appropriate in the context of this manuscript. This expert opinion report provides a detailed review of the limited evidence available regarding long-term use of topical therapies for the management of psoriasis, alongside our key considerations and recommendations to assist dermatologists with the implementation of topicals as part of long-term management strategies. Long-term management should be considered mandatory to ensure patients receive appropriate proactive treatment which may help optimize adherence and long-term outcomes.

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An investigator-initiated, double-blind, vehicle-controlled pilot study: Assessment for tachyphylaxis to topically occluded halobetasol 0.05% ointment in the treatment of psoriasis

Cited by 10 publications

References 19 publications

Conversion back to bevacizumab or ranibizumab for recurrent neovascular activity with aflibercept in age-related macular degeneration: a case series

Conversion back to bevacizumab or ranibizumab for recurrent neovascular activity with aflibercept in age-related macular degeneration: a case series

Use of an alternative method to evaluate erythema severity in a clinical trial: difference in vehicle response with evaluation of baseline and postdose photographs for effect of oxymetazoline cream 1·0% for persistent erythema of rosacea in a phase IV study

Long-term topical management of psoriasis: the road ahead

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