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Headline box does not go smaller, but can go bigger Betamethasone Valerate Medicated Plaster (BMVP) Author name box (not in Ask pharma or News) 2.250 (Betesil®) Product Review Space mg Polly Buchanan Article intro table or text if no table

Buchanan P. Betamethasone Valerate Medicated Plaster (BMVP) 2.250 mg (Betesil®) Product Review. Dermatological Nursing 2019. 18(1):42-45

Introduction corticosteroid (betamethasone (elbows, knees, anterior skin of tibia and Managing chronic inflammatory skin valerate 2.250 mg) impregnated into heels) and offers controlled sustained conditions is the mainstay of our an adhesive plaster (Betesil®), which release of betamethasone valerate work in dermatology. Inflammatory is specifically indicated for difficult to 2.250 mg for a period of up to 24 hours. skin conditions such as psoriasis and treat recalcitrant inflammatory skin eczema are so very common with many conditions such as localised chronic What is the clinical evidence? different clinical presentations. Not all psoriasis plaques, eczema, lichenification, The LIBERE study was an open label, persons with a skin condition are eligible granuloma annulare, mycosis fungoides, multicentre, prospective, observational for systemic treatments and therefore lichen planus and palmoplantar study for BMVP in persons with any the fundamentals of management inflammatory lesions.2 inflammatory dermatoses amounting to continue to be appropriate topical less than 5% of the body surface area. corticosteroid therapies which remain Betamethasone Valerate Medicated Plaster - 258 respondents were recruited, the a therapeutic class for inflammatory BMVP (Betesil®) majority of which had psoriasis (49%), dermatological conditions.1 eczema (34%), or other dermatoses What is BMVP (Betesil®)? (17%). Pre and post treatment clinical The art and the science of Betesil® is a licensed product available evaluations included disease severity, management becomes evident when in the UK for the management of using the Physician Global Assessment we, as health professionals, consider inflammatory dermatoses which do (PGA) score, patient satisfaction and what topical treatments are available for not respond to less potent topical Quality of Life using the Dermatology specific conditions and presentations. steroids. The cutaneous effects are due Life Quality Index (DLQI). The BMVP For example, the topical management to the anti-inflammatory, anti-pruritic,

one considers for guttate psoriasis may anti-proliferative and vasoconstrictive ® differ to that considered for chronic properties of its active ingredient Betesil can be applied large plaque psoriasis or localised betamethasone valerate.3 once daily to specific plantopustular psoriasis. Similarly, inflammatory lesions, within the ‘eczema’ range, the topical The technically advanced adhesive on not more than 5% treatments suggested for atopic plaster is intended for difficult to treat of total BSA eczema can differ considerably to that areas such as the extensor surfaces of nummular eczema, or seborrheic eczema. In addition, inflammatory skin lesions in difficult to treat areas always represent a clinical challenge for both health professional and patient.

This article is a product review of a well-known potent topical

Polly Buchanan is a Community Dermatology Nurse Practitioner, NHS Fife, Clinical Editor of Left hand column Author info box aligned bottom Dermatological Nursing and an Independent/ Supplementary Nurse Prescriber

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Note: This image shows the application of a placebo plaster. For application guidance always refer to the SmPC or PIL. Cutting techniques are available at betesil.co.uk.

was applied daily for up to 4 weeks as The flexibility of the plaster to the bioavailability of BMV cream, per manufacturer’s recommendations. with and without occlusion, following Results indicated that betamethasone lends itself to application repeated applications. Results indicated valerate medicated plaster was well- over lesions on skin and that the percutaneous absorption of tolerated and effective in the treatment joints subject to increased BMV from the plaster applications of inflammatory dermatoses, improving movement such as the was noted to be below the limit of clinical signs as well as patients’ quality elbows and knees quantification (0.5 mg/ml) in about of life. The greatest improvement in half of the subjects in that treatment clinical assessment and DLQI reported group. Percutaneous absorption of by respondents was with eczema. BMV were found in any of the blood BMV cream group was below the limit Respondents reported the BMVP was tests of healthy respondents.5 of quantification in all but one subject. more effective than previous therapies Researchers concluded that although (93.5% very satisfied and 90.4% satisfied), Safety of BMVP studies have also the bioavailability of BMV is higher in the and ease of use and rapidity of application been undertaken with persons with plaster application group, levels of active were rated as good or very good.4 psoriasis. Following repeated applications, substance remained very limited.7 blood plasma levels of BMV were An early phase I safety study on deemed to be lower than normal blood A safety and efficacy randomised healthy individuals demonstrated that cortisol levels and therefore too low to controlled trial demonstrated that following repeated BMVP patch tests cause any systemic toxic effects.6 BMVP was more efficacious than BMV over 19 days, whereby the BMVP cream with a statistically significant patches were applied for 24 and 48 Another study explored the difference (p<0.001 versus BMV cream) Left hand column Author info box aligned bottom hours, no detectable concentrations of bioavailability of BMVP as compared in clearance of mild to moderate

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When not to use Betesil®? Betesil® is contraindicated if there Headline box does not go smaller, but can go bigger is any hypersensitivity to the active ingredient or any excipients. Avoid application on any lesions considered to be bacterial, viral or fungal. This includes tuberculosis of the skin, herpes Author name box (not in Ask pharma or News) simplex and herpes zoster. It is also contraindicated for inflammatory Space lesions such as acne, rosacea, perioral dermatitis as well as ulcers, burns and frostbite. Facial use should be avoided. Article intro table or text if no table It should not be used on patients under 18.2

Is Betesil® a high-quality product? plaque psoriasis at 3 weeks, which was published and identified the clinical Betesil® feels like a high-quality product, sustained at 5 weeks. No differences benefits as being increased controlled well packaged, with individual plasters were demonstrated in safety as release and penetration of active contained in individual foil sachets. assessed by reported adverse events.8 ingredient into the area requiring The colourless, translucent plasters are treatment, enhanced skin hydration and flexible and adhere readily to clean A large multicentred, prospective, protection from trauma or scratching.3 dry skin. If using portions of the plaster assessor blinded, randomised controlled at any one time, the residual plaster trial compared BMVP with calcipotriol- Assessment of efficacy for potent can remain within the packaging for betamethasone dipropionate fixed dose BMVP (potent corticosteroid) with subsequent applications. An open foil combination ointment over a 4 week fludroxycortide tape (moderately plaster pack can be used for up to treatment period. 324 patients with potent corticosteroid), and with 1 month before discarding. An unopened psoriasis were recruited. Researchers other potent topical corticosteroid plaster pack has a shelf life of 3 years. concluded that both treatments creams or ointments under occlusion significantly improved patients’ with different dressings would not be Have others had a good experience with psoriasis and Quality of Life. Results relevant comparators, because mode of the product? also demonstrated the BMVP is non- delivery and absorption rates differ. In reviewing the literature and evidence inferior to calcipotriol-betamethasone surrounding BMVP, patient feedback dipropionate fixed dose combination Is the product easy to use? and satisfaction appear to be high, ointment, and significant QOL Betesil® can be applied once daily to with many positive comments in the improvement was also preserved during specific inflammatory lesions, on not literature regarding improving Quality the 8 week follow up period.9 more than 5% of total BSA. The plaster of Life, ease of use, preference over can be cut to shape to fit the lesions greasier creams and ointments, less A small, phase II, single centre, exactly, left in situ for 24 hours, then mess, less staining of clothes. Patient randomised, investigator blinded, ‘within removed prior to bathing or showering preference and choice is always useful patient’ comparator, 4 week study was before the next application. Subsequent in enhancing patient concordance. undertaken. BMVP was compared with daily applications can be applied for up calcipotriol-betamethasone dipropionate to 30 days. The manufacturers advise 30 What are the pros and cons of the product? aerosol foam covered with non-occlusive minutes between each application. The Betesil® is recommended for difficult gauze in 35 patients with psoriasis quite gentle adhesive properties aid with to treat areas and incorporates an (SPC states avoid occlusive dressings).10 preventing cell stripping, and the outer innovative technology within the Results demonstrated that both surface of the plaster acts as a barrier patented plaster, which may well treatments were well tolerated with and reduces any peeling or friction from enhance resolution of inflammatory calcipotriol-betamethasone dipropionate clothing or movement. In my recent use lesions such as psoriasis plaques, foam showing superior efficacy in total of the product I experienced no issues eczema and lichenification of the skin. clinical scores (sum of erythema, scaling in cutting to size, or application. Mobile It demonstrates efficacy in clinical and infiltration scores).11 However, as this extensor surfaces such as the elbow, trials, is simple to apply, and has a good was a small scale study, further research knees and heel may require additional safety profile. It is the only adhesive is required. adhesive tape to secure the plaster in product currently available which place for 24 hours. Evidence supports this, contains a potent topical corticosteroid A recent review of the role of with research findings indicating it is easier (betamethasone valerate), providing Left hand column Author info box aligned bottom BMVP 2.250 mg in the management to use, particularly on difficult to treat sustained release of the active of psoriasis and other dermatoses was areas such as the elbows and knees.3 ingredient targeted only on the localised

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area over a 24 hour period. This will wear, and once a day application which be a useful addition to the treatments helps hydrate the lesions. Each Betesil® References: available for recalcitrant inflammatory plaster can be cut to size to suit the 1. Anigbogu, A et al. Topical Corticosteroid Headline box does not go smaller, but can go bigger lesions such as thick chronic psoriasis dimensions of the lesion being treated, Therapy. In: Millikan, L (ed.) Drug Therapy in plaques, chronic lichenified eczema, thereby avoiding wastage. In addition Dermatology. Chapman and Hall/CRC; 2000. P. 1-29. lichen planus and other dermatoses. to this each plaster is individually ® The flexibility of the plaster lends itself wrapped for better hygiene. 2. Derma UK Ltd. Summary of Betesil Product Characteristics (SmPC). 2018. to application over lesions on skin and 3. Ly S et al. Role of betamethasone valerate Author name box (not in Ask pharma or News) joints subject to increased movement 2.250 mg medicated plaster in the treatment of such as the elbows and knees. Space ® psoriasis and other dermatological pathologies: Additional adhesive tape is included to Betesil is indicated for a review. Department of Dermatology, Saint Andre secure the plaster in place over a 24 localised difficult to treat Hospital. Drugs in Context. 2018; 7 1-11. Article intro table or text if no table hour period should this be required. inflammatory dermatoses 4. Maccari F. Improvement of inflammatory which have not responded dermatoses severity and quality of life in patients treated with a betamethasone valerate plaster Potent topical corticosteroids are to mild to moderate topical used with care and caution. The abrupt (LIBERE study). Journal of Dermatological Treatment. 2016; 27(1): 59-63. cessation of potent topical steroids corticosteroid therapy and the potential for rebound is a 5. Rusca A. Skin sensitization potential of a 0.1% BMV tape. Repeat Insult Patch Test (RIPT). Data common concern and requires careful on file IBSA Institut Biochimique SA, Lugano, management. BMVP is recommended A direct cost comparison to Switzerland. 1999. 23. as a daily application for up to 30 days. fludroxycortide tape is not realistic as 6. Ortonne JP. Evaluation of the systemic effects In order to avoid stopping abruptly the potency of steroid within the tape of IBSA Tape (betamethasone valerate 0.1% tape) it is recommended that once an (moderately potent) and BMV plaster after repeated applications on the skin of normal appreciable improvement has been (potent) differs, while clinical indications healthy subjects and psoriatic patients. Data obtained, applications of BMVP can may also differ. However, Betesil® on file IBSA Institut Biochimique SA, Lugano, Switzerland. 2003. be discontinued with the option of (4x10cm, £13.98), does appear to be continuing treatment with a less potent more cost effective when compared to 7. Ortonne JP. Evaluation of the systemic effects of IBSA BMV (betamethasone 0.1% medicated corticosteroid or emollient. fludroxycortide tape (20cm, £12.49). plaster) applied on the skin of psoriatic patients versus a reference 0.1% BMV cream. Data on The cost of any product is an Conclusion file IBSA Institut Biochimique SA, Lugano, important consideration. The price of Betesil® is indicated for localised difficult Switzerland. 2008. Betesil® in the UK is £13.98 per pack. to treat inflammatory dermatoses 8. Naldi L et al. Efficacy and Safety of Each pack contains 4 plasters. Each which have not responded to mild Betamethasone Valerate 0,1% Plaster in Mild- plaster provides a surface area of 7.5cm to moderate topical corticosteroid to-Moderate Chronic Plaque Psoriasis: A x 10cm and each plaster can be cut therapy. Research evidence supports randomized, Parallel-Group, Active-Controlled, Phase III Study. American Journal of Clinical to the dimensions of the lesion being safety and efficacy of the BMV Dermatology. 2011; 12(3):191-201. treated. Following cutting, the remaining impregnated plaster. Besides the 9. Ortonne JP. Et al. Betamethasone valerate unused plaster can be returned to the patented technology of the medicated dressing is non-inferior to calcipotriol- sachet, and once opened the plaster has plaster, added benefits include once a betamethasone dipropionate ointment in the a shelf life of 1 month. The cost per day day application, enhanced hydration treatment of patients with mild-to-moderate is really dependent on the condition of the lesions, protection from trauma chronic plaque psoriasis: results of a randomized being treated and surface area affected. and itch and accurate measured assessor-blinded multicentre trial. Journal dosing of the active ingredient over 24 of the European Academy of Dermatology and Venereology. 2014; 2(9): 1126-1134. The cost-effective argument for Betesil® is based on hours. It represents a useful addition 10. Enstilar. Prescribing Information. the following factors to the armoury of topical treatments Available from: https://enstilar.co.uk/prescribing- Compared with other topical creams available for persons living with chronic information/ [Accessed 21st February 2019]. ® and ointments patient compliance can be inflammatory skin conditions. Betesil 11. Queille-Roussel et al. Efficacy and safety of enhanced due to the accurate metered has recently been submitted for listing calcipotriol plus betamethasone dipropionate dosage delivered over a 24 hour period, in the BNF and Derma UK are awaiting aerosol foam compared with betamethasone specifically to the localised area. This will confirmation of this. Derma UK are also 17-valerate-medicated plaster for the treatment prevent the user from applying too much planning an application to the Scottish of psoriasis. Clin Drug Investig. 2017; 37(4): or too little BMV. It may help reassure Medicines Consortium. 355-361. the patient, carer and health professional The author has no financial conflict if steroid phobia is evident. Useful educational tools for health of interest in this or any other professionals and patients are available medicinal product. Persons living with a chronic online at www.betesil.co.uk and inflammatory skin condition may prefer include an application video and a This article is a product review Left hand column Author info box aligned bottom commissioned by Derma UK the occlusive BMVP as an as easy to cutting template. DN

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