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.
BACKGROUND
Atopic dermatitis (AD) is a common inflammatory allergic disease of children. The primary anti-inflammatory therapy is topical steroids. An effective treatment without the topical and systemic adverse effects of corticosteroids would be useful. Topical formulations of sodium cromoglicate have been researched in the past, but without consistent results. We report a trial of a new aqueous skin lotion of sodium cromoglicate (Altoderm) in children with AD.


OBJECTIVE
To compare the efficacy, safety and acceptability of Altoderm lotion with a placebo control in the treatment of AD in children.


METHODS
A double-blind, controlled study in which children aged 2-12 years with AD were randomized to 12 weeks of treatment with a lotion containing 4% sodium cromoglicate (Altoderm) or the lotion base. To be included subjects had to have a SCORAD score of > or = 25 and < or = 60 at both of two clinic visits 14 days apart. Subjects continued using existing treatment which included emollients and topical steroids. The primary outcome was the change in the SCORAD score. The two groups were compared for the change in the SCORAD score from the second baseline visit to the visit after 12 weeks of treatment using an analysis of variance. Secondary outcome measures included parents' assessment of symptoms, usage of topical steroids recorded on daily diary cards, and final opinions of treatment by parent and clinician. Parents were asked about adverse effects at each clinic visit and the responses recorded.


RESULTS
Fifty-eight children were randomized to Altoderm and 56 to placebo and all were included in the intention-to-treat analysis. The mean +/- SD SCORAD scores at baseline were 41.0 +/- 9.0 (Altoderm) and 40.4 +/- 8.73 (placebo). These scores were reduced after 12 weeks by 13.2 (36%) with Altoderm and by 7.6 (20%) with placebo. The difference of 5.6 (95% confidence interval 1.0-10.3) is statistically significant (P = 0.018). Diary card symptoms improved with both treatments but the improvement was greater in the Altoderm-treated patients. Topical steroid usage was reduced in both groups and was larger in the Altoderm-treated patients. The differences were statistically significant for the mean of all symptoms, the overall skin condition and use of topical steroids. Those for itching and sleep loss were not. Treatment-related adverse events were reported in 11 subjects (Altoderm seven, placebo four). Most of these referred to irritation, redness and burning at the site of application. There were four reports of erythema and pruritus (Altoderm three, placebo one), and three reports of application site burning (Altoderm two, placebo one). None was reported as severe or very severe.


CONCLUSIONS
These results show a clinically useful benefit of this sodium cromoglicate lotion in children with moderately severe AD.
Stainer
R
R
Synexus Limited, Crosby Clinical Research Centre, Burlington House, 3rd Floor, South Wing, Crosby Road North, Waterloo, Liverpool, UK.
Matthews
S
S
Arshad
S H
SH
McDonald
S
S
Robinson
J
J
Schapira
C
C
Foote
K D
KD
Baird-Snell
M
M
Gregory
T
T
Pollock
I
I
Stevens
M T
MT
Edwards
A M
AM
D000279:Administration, Cutaneous; D002648:Child; D002675:Child, Preschool; D004205:Cromolyn Sodium / Q000009:adverse effects / Q000627:therapeutic use*; D003876:Dermatitis, Atopic / Q000188:drug therapy* / Q000473:pathology; D003879:Dermatologic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005938:Glucocorticoids / Q000008:administration & dosage; D006801:Humans; D008297:Male; D017060:Patient Satisfaction; D012720:Severity of Illness Index; D016896:Treatment Outcome
D003879:Dermatologic Agents; D005938:Glucocorticoids; D004205:Cromolyn Sodium