Efficacy and acceptability of a new topical skin lotion of sodium cromoglicate (Altoderm) in atopic dermatitis in children aged 2-12 years: a double-blind, randomized, placebo-controlled trial

• DOI: 10.1111/j.1365-2133.2004.06303.x
• Publication Date: 2005-02-23T13:16:25Z
• Authors: R. Stainer; S. Matthews; S.H. Arshad; S. McDonald; J. Robinson; C. Schapira; K.D. Foote; M. Baird-Snell; T. Gregory; I. Pollock; M.T. Stevens; A.M. Edwards
• Keywords: Lotion; SCORAD; Placebo-controlled study; Topical medication

Background Atopic dermatitis (AD) is a common inflammatory allergic disease of children. The primary anti-inflammatory therapy topical steroids. An effective treatment without the and systemic adverse effects corticosteroids would be useful. Topical formulations sodium cromoglicate have been researched in past, but consistent results. We report trial new aqueous skin lotion (Altoderm) children with AD. Objectives To compare efficacy, safety acceptability Altoderm placebo control AD Methods A double-blind, controlled study which aged 2–12 years were randomized to 12 weeks containing 4% or base. included subjects had SCORAD score ≥ 25 ≤ 60 at both two clinic visits 14 days apart. Subjects continued using existing emollients outcome was change score. groups compared for from second baseline visit after an analysis variance. Secondary measures parents' assessment symptoms, usage steroids recorded on daily diary cards, final opinions by parent clinician. Parents asked about each responses recorded. Results Fifty-eight 56 all intention-to-treat analysis. mean ± SD scores 41·0 9·0 40·4 8·73 (placebo). These reduced 13·2 (36%) 7·6 (20%) placebo. difference 5·6 (95% confidence interval 1·0–10·3) statistically significant (P = 0·018). Diary card symptoms improved treatments improvement greater Altoderm-treated patients. steroid larger differences overall condition use Those itching sleep loss not. Treatment-related events reported 11 (Altoderm seven, four). Most these referred irritation, redness burning site application. There four reports erythema pruritus three, one), three application two, one). None as severe very severe. Conclusions results show clinically useful benefit this moderately