A study to evaluate the effectiveness of adding an oral second generation, non sedating, H1 antihistamine (Fexofenadine) to topical treatment in achieving better clinical outcome in paediatric patients of atopic dermatitis

Atopic Dermatitis (AD)is a common, chronically relapsing inflammatory skin disease characterised by eczema and episodes of extreme pruritus that usually start in infancy and may progress into adulthood. AD treatments are mostly aimed at relieving inflammation with the use of topical corticosteroids and topical calcineurin inhibitors, and in more severe cases, systemic immunosuppressants. Oral antihistamines have traditionally been prescribed as adjuvant therapy with topical agents with the aim of relieving pruritus by antagonising the action of histamine on its cutaneous receptors. Nonetheless, their clinical efficacy is still disputed and it has been claimed that the role of antihistamines in AD management is essentially limited to their soporific effects.

Our study aims to compare the effectiveness of adding oral fexofenadine to topical treatment in paediatric patients of AD. We aim to quantify the response using clinical and serological markers. The study design will be an observer blinded, parallel group, comparative study wherein paediatric patients of mild to moderate AD will be randomized into two groups. The first group will receive appropriate topical treatment along with oral fexofenadine while the second group will receive topical treatment alone for a period of 8 weeks. All patients will be followed up to assess the improvement of clinical symptoms by the Scoring Atopic Dermatitis Index (SCORAD) and the 5 D Itch Score. Simultaneously, the pre and post treatment levels of interleukin 31 will be measured by ELISA to assess the effect of both treatment modalities on the inflammatory pathway.