Efficacy of Bufexamac (NFN) Cream in Skin Diseases

Abstract

The effect of a new non-steroid anti-inflammatory substance (bufexamac) in a special constituent was compared with that of 0.1% triamcinolone acetonide, 1% hydrocortisone cream, and placebo during a double-blind multicentre trial. The clinical effect of these four creams was studied in 193 patients receiving treatment for the following skin disorders: atopic dermatitis, allergic contact dermatitis, and non-allergic contact dermatitis, as well as dermatitis seborrheica. After 2 and 4 weeks’ treatment, when 193 and 157 patients, respectively, were re-examined, the effect of triamcinolone acetonide and hydrocortisone cream was significantly better, than that obtained with bufexamac in the cream basis employed. On the other hand, no statistically significant difference in effect between bufexamac and placebo cream was observed.

Severe allergic contact dermatitis caused by topical bufexamac requiring hospitalization

“…Bufexamac is a NSAID used for the local treatment of various dermatoses, despite its lack of efficacy. 1 It has never been approved for use in the United States and the United Kingdom, and in 2010 the European Medicines Agency Committee recommended that marketing authorization for medicines containing bufexamac be revoked throughout the EU. 2 However, in some countries, such as Australia and Switzerland, bufexamac is still readily available for purchase in pharmacies, most commonly as an ingredient in "first aid creams.…”

“…Bufexamac is a NSAID used for the local treatment of various dermatoses, despite its lack of efficacy . It has never been approved for use in the United States and the United Kingdom, and in 2010 the European Medicines Agency Committee recommended that marketing authorization for medicines containing bufexamac be revoked throughout the EU .…”

Eine heimtückische und häufige Nebenwirkung: Kontaktallergien durch das Ekzemtherapeutikum Bufexamac. Ergebnisse des IVDK

“…Bufexamac-haltige Ekzemsalben zeigten in älteren Untersuchungen keine, oder eine kaum bessere Wirkung als Placebo (4,22). Andere Studien, die sich z.T.…”

Non‐steroidal anti‐inflammatory drugs selectively inhibit cytokine production by NK cells and γδ T cells

“…Among the various classes of NSAIDs, aspirin (acetylsalicylic acid) is the oldest and most widely prescribed NSAIDs for systemic use. On the other hand, the structurally unrelated NSAIDs, indomethacin and bufexamac (2‐( p ‐butoxyphenyl)‐acetyl‐hydroxamatic acid), have been widely prescribed for both systemic and topical use: in particular, the latter is available over the counter for various indications and is widely used for the local treatment of various dermatoses including atopic dermatitis (AD) and viral infections (14), although not generally prescribed for systemic use. However, NSAIDs have been shown to exacerbate allergic diseases such as urticaria, AD and asthma (15–17), which are caused by the overproduction of Th2 cytokines in allergen‐specific T cells.…”