| The girl who had difficulty sleeping at night |
| Childhood eczema - a story of treatment success |
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| From Emma’s mum: |
“Emma’s skin is red, itchy and covered in weeping sores.
Other children won’t play with her. They say her skin is disgusting. She often comes home from school crying. Emma’s teacher complains that she doesn’t concentrate in class – which is understandable as she can’t sleep at night because of the itching. |
A flare for Emma means at least two weeks of misery for our whole family, including our younger son. My husband and I feel guilty because nothing seems to help Emma.
On top of all this, we worry about whether Emma’s treatment could have long-term side effects.” |
| This is a hypothetical case study, reflective of real world experience only. |
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Choose Cutivate for proven efficacy and tolerability in paediatric patients5,6 |
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A high level of efficacy in children aged 2–14 years with moderate-to-severe atopic dermatitis6
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– Significantly more effective than hydrocortisone butyrate* (p=0.042)6
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Similar tolerability to hydrocortisone 1.0%, a lower potency steroid6
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No clinically significant effects on the HPA axis in infants with moderate-to-severe atopic dermatitis (n=51) treated with Cutivate cream (0.05%) applied twice daily for 3–4 weeks5
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Low incidence rates of skin atrophy in infants, even as young as 3 months old, using Cutivate continuously for up to 4 weeks to treat a flare5
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3 events of telangiectasia. Fewer patients had abnormal pigmentation during and after treatment (11% -14%) than at baseline (22%)5
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| A potent topical treatment designed for efficacy and tolerability in steroid-responsive dermatoses6,9-12 |
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| Depending on the formulation, side effects that may occur include but are not limited to: pruritus (common), local skin burning (uncommon), and very rarely, skin atrophy, pigmentation changes or other skin adverse events.13
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| Prescribing information |
| CUTIVATE – Abbreviated Prescribing Information: Please refer to full Summary of Product Characteristics (SPC) before prescribing.
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Trade name: Cutivate 0.005% ointment; 0.05% cream. Active Ingredient: Fluticasone Propionate 0.05% w/w (cream); 0.005% w/w (ointment). Pharmaceutical Form: Ointment; Cream. Indications: Adults: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses such as: eczema ; prurigo nodularis; psoriasis (excluding widespread plaque psoriasis); lichen planus; seborrhoeic dermatitis; contact sensitivity reactions; an adjunct to systemic steroid therapy in generalised erythroderma; insect bite reactions; prickly heat. Children: Children and infants aged three months and over who are unresponsive to lower potency corticosteroids; relief of the inflammatory and pruritic manifestations of atopic dermatitis under the supervision of a specialist. Posology and Method of Administration: Apply a thin film to the affected skin areas twice daily until improvement occurs. In children, if there is no improvement within 7-14 days, withdraw treatment. Continuous daily treatment for longer than 4 weeks is not recommended. Contraindications: Rosacea; acne vulgaris; perioral dermatitis; hypersensitivity; perianal and genital pruritus; dermatoses in infants under 3 months of age, including dermatitis and nappy rash. Special Warnings and Precautions: Prolonged applications of high doses might lead to adrenal suppression. The face may exhibit atrophic changes after prolonged treatment. Care is needed to ensure that the preparation does not enter the eye. Careful supervision is important in psoriasis. Spread of infection requires withdrawal of topical corticosteroid therapy. Interactions with other medicaments: Increased systemic exposure is shown when co-administered with drugs that can inhibit CYP3A4. Fertility, Pregnancy and Lactation: No data in humans on fertility; Safe use during pregnancy and lactation has not been established. Administration during pregnancy and lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus or baby. Effect on Ability to Drive or Use Machines: No studies. Side Effects: Common (less than 1 in 10): Pruritus. Uncommon (less than 1 in 100): Local skin burning. Very Rare (less than 1 in 10,000): Adrenal suppression, hypersensitivity and allergic contact dermatitis. Overdose: Treatment should be clinically managed. Local Presentation: 15 g ointment/cream. Marketing Authorisation Holder: Glaxo Wellcome UK Ltd, trading as GlaxoSmithKline UK. MA Number: MA167/00502 (ointment); MA167/00501 (cream). Legal category: POM. For further information and full prescribing information contact GlaxoSmithKline (Malta) Ltd: Tel. 21238131. Date of preparation: November 2015 |
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REPORTING ADVERSE EVENTS (AEs): If you become aware of any AEs, medication errors and/or use during pregnancy in association with GSK products, please report the event promptly to: GSK (Malta) Ltd, 1, De la Cruz Avenue, Qormi QRM 2458, Malta (Tel: +356 21238131)
Alternatively, any suspected AEs and medication errors can be reported via the Medicines Authority Adverse Drug Reactions reporting website: www.medicinesauthority.gov.mt/adrportal
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| References: |
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1. Zuberbier T et al. J Allergy Clin Immunol. 2006;118(1):226-232. 2. Sanchez J et al. Revista Alergia México. 2014;61:178-211. 3. Sargen MR et al. J Invest Dermatol. 2014;134:51-57. 4. Silverberg JI et al. J Invest Dermatol. 2015;135:56-66. 5. Friedlander SF et al. J Am Acad Dermatol. 2002;46(3):387-393. 6. Kirkup ME et al. J Dermatolog Treat. 2003;14(3):141-148. 7. National Institute for Health and Care Excellence (NICE). NICE Technology Appraisal Guidance 81. August 2004. 8. Warde Medical Laboratory. Appendix: endocrinology. 2006. Available at: http://web.archive.org/web/20060506204843/ http://www.wardelab.com/Appendix09_ACTHa.pdf. Accessed January 23, 2016. 9. Johnson M. J Allergy Clin Immunol. 1998;101(4 Pt 2):S434-439. 10. Dollery C. Therapeutic Drugs. London, England. Elsevier Health Sciences; 1994. 11. Johnson M. Cutis. 1996; 57(2 Suppl):10-12. 12. Cutivate cream and ointment SPC (Aug 2014). 13. Fluticasone propionate Global Datasheet (topical) 2011. |
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Date of preparation: August 2016
Job code: MLT_GIB/FPC/0003/16 |
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