Tolerability of and Adherence to Topical Treatments in Atopic Dermatitis: A Narrative Review

Tier, Heather L.; Balogh, Esther A.; Bashyam, Arjun M.; Fleischer, Alan B.; Spergel, Jonathan M.; Masicampo, E. J.; Kammrath, Lara K.; Strowd, Lindsay C.; Feldman, Steven R.

doi:10.1007/s13555-021-00500-4

Cited by 22 publications

(15 citation statements)

References 26 publications

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“…Studies have demonstrated that product efficacy, safety and convenience all play a key role in ensuring the highest possible adherence to therapy by patients [ 1 – 4 , 47 ]. Patients with psoriasis and atopic dermatitis have been reported to miss up to around 70% of planned topical applications when the treatment period extends to several weeks, leading to suboptimal treatment outcomes, reduced quality of life and increased healthcare costs [ 1 , 13 , 48 , 49 ]. Patients generally prefer light, moisturizing, non-greasy and quickly absorbed vehicles for reasons of ease of application and aesthetic acceptability [ 50 ].…”

Section: Discussionmentioning

confidence: 99%

Polyaphron Dispersion Technology, A Novel Topical Formulation and Delivery System Combining Drug Penetration, Local Tolerability and Convenience of Application

Præstegaard

Steele²,

Crutchley

2022

Dermatol Ther (Heidelb)

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Topical formulation and delivery technologies for pharmaceutical application should simultaneously address efficacy, safety and convenience of therapy. This has historically proven to be challenging, since formulation features that drive efficacy often have undesirable consequences for safety and convenience and vice versa. Polyaphron dispersion (PAD) technology is a novel topical formulation and drug delivery system developed with the purpose of preserving these key attributes. PAD formulations are typically oil-in-water dispersions consisting of oil droplets encapsulated in a multi-molecular shell structure. This shell structure protects potentially unstable active molecules solubilized in the oil from hydrolytic degradation. Example data are presented of enhanced drug penetration from PAD formulations, including dermal delivery of calcipotriene, betamethasone dipropionate and tacrolimus as well as ocular delivery of ciclosporin A. Local tolerability is an important safety parameter for topical formulations, where high levels of surfactants can cause skin irritation. In this regard, a key benefit of PAD formulations is the inherent reduced requirement for surfactants to generate stable formulations compared to conventional emulsion systems. Patients with chronic diseases with topical manifestations such as psoriasis or atopic dermatitis have been reported to miss up to 70% of planned topical applications, mainly due to a lack of satisfaction with their therapy. Patients generally prefer light, moisturizing, non-greasy and quickly absorbed vehicles that are simple to use on all body parts. PAD formulations can generally be designed to meet these criteria. In conclusion, PAD technology provides high flexibility in topical drug design and can be applied to several body locations without compromising efficacy, safety or convenience of therapy. Clinical Trial Register : Clinicaltrials.gov: NCT03802344.

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Section: Discussionmentioning

confidence: 99%

Polyaphron Dispersion Technology, A Novel Topical Formulation and Delivery System Combining Drug Penetration, Local Tolerability and Convenience of Application

Præstegaard

Steele²,

Crutchley

2022

Dermatol Ther (Heidelb)

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“…Proaktivno doziranje: održavanje postignutog efekta i nakon sanacije akutne egzacerbacije hronične dermatoze (najčešće psorijaza ili atopijski dermatitis) primenom kortikosteroidnog preparata 2 puta nedeljno još neki period, do prestanka korišćenja kortikosteroida. Može se kombinovati sa drugim aktivnim medikamentima (kalcineurin inhibitorima ili kalcipotriolom) [17][18] .…”

Section: Strategije Optimizacije Hronične Topikalne Kortikosteroidne ...unclassified

Corticosteroid topical therapy range: Fluocinolone-acetonide gel

Gajinov¹

2022

Galenika Med J

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Since the early days of use, in the mid of twentieth century, topical corticosteroids became the basis of contemporary dermatological therapy, because of their antiinflammatory efficiency, comfort of application free from unpleasant characteristics of previous generations of dermatotherapeutics, tar or antralin. With numerous evidences about potencies of specific corticosteroid molecules for adverse effects, optimal and efficient use of topical corticosteroid is the empiric art of dermatology, based on precise diagnosis, knowledge about the pathophysiology of dermatosis and characteristics of topical medication, and good communication with patients to promote optimal use of therapy. There are numerous strategies for optimization of skin atrophy risk and suboptimal therapeutic efficacy, caused by too restrictive topical drug use. Preferences of patients with chronic dermatoses are an important factor for good adherence with therapy, generally favoring formulations that are easier for application, less occlusive and less time-consuming. In most medical systems Fluocinolon gel is topical steroid formulation continuously present from the early days of use. It is adequate for use both for glabrous and hair-bearing skin and for oral mucosa also. A long history of use, the knowledge about effiancy and adverse effects make fluocinolone gel the important part of topical corticosteroid palette, parallel with new modern formulations.

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“…Some trials supply TCS directly to participants [ 14 , 17 ], which minimizes barriers to use. In such trials, participants may use TCS more consistently and in greater amounts than they would in the real-world where a prescription is typically required [ 28 ]. Other trials do not supply TCS and require participants to obtain new TCS prescriptions [ 10 , 13 ].…”

Section: Key Clinical Trial Parameters That Impact Interpretation Of Efficacy Outcomesmentioning

confidence: 99%

Expert Perspectives on Key Parameters that Impact Interpretation of Randomized Clinical Trials in Moderate-to-Severe Atopic Dermatitis

et al. 2021

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The recent advent of numerous clinical trials for the treatment of moderate-to-severe atopic dermatitis has led to new and emerging therapeutic options for this chronic inflammatory skin disease. With this rapid development has come a lack of consistency in study designs, trial conduct, and statistical analyses. Healthcare providers are challenged to interpret how variations in study parameters may influence clinical trial results. Based on literature review and our experience as clinical trialists, we compiled a list of 22 key study parameters of contemporary clinical trials in moderate-to-severe atopic dermatitis and ranked the top study parameters that may have a significant effect on efficacy results. The top parameters included study comparators, rules for rescue treatment, washout periods for topical and systemic treatments, inclusion criteria such as disease severity by Eczema Area and Severity Index and/or Investigator Global Assessment scores, and the duration of the screening period. We describe considerations for these key parameters, with a focus on between-parameter interactions and effect on efficacy results. This may serve to inform the interpretation of atopic dermatitis clinical trials and raise the profile of the need to harmonize the clinical trial design. Plain Language SummaryAtopic dermatitis (AD) is a skin disease characterized by red, itchy skin that is highly burdensome for patients. Patients with moderate-to-severe disease have large, inflamed skin areas with frequent itching. Recently, the number of clinical trials for drugs that treat moderate-to-severe AD has rapidly increased, with differences in how these trials are designed. There is a need for healthcare providers examining results from different clinical trials to understand how trial design factors might influence study outcomes. In this article, we identify key trial design factors that impact study outcomes, detail how these factors can impact clinical trial results, and explore how these factors interact with one another to affect study outcomes. The five most important design factors, as determined via author surveys, were study comparators (a placebo and/or another drug to which the drug being studied is compared); the rules for the use of rescue treatment (a form of treatment given if an enrolled participant has uncontrolled AD symptoms); washout periods (the time before the trial when previous treatments are stopped to allow them to be cleared from a patient's system); inclusion criteria (that determine which participants are included); and the length of the screening period (the time when patients are assessed to determine if they qualify for participation). By understanding how these key trial design factors impact on study outcomes, healthcare providers may be equipped to better interpret different AD clinical trials. This work also emphasizes the value of harmonizing the AD clinical trial design.

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Tolerability of and Adherence to Topical Treatments in Atopic Dermatitis: A Narrative Review

Cited by 22 publications

References 26 publications

Polyaphron Dispersion Technology, A Novel Topical Formulation and Delivery System Combining Drug Penetration, Local Tolerability and Convenience of Application

Polyaphron Dispersion Technology, A Novel Topical Formulation and Delivery System Combining Drug Penetration, Local Tolerability and Convenience of Application

Corticosteroid topical therapy range: Fluocinolone-acetonide gel

Expert Perspectives on Key Parameters that Impact Interpretation of Randomized Clinical Trials in Moderate-to-Severe Atopic Dermatitis

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