Q:

1/10/2013
I have an adult in his 50's with diffuse atopic dermatitis. He is asking about oral cromolyn use in this condition. I have found some old articles in pediatric patients. Is there any data in adults?

A:

Thank you for your inquiry.

I am not aware of oral cromolyn sodium being of help in atopic dermatitis. There is a body of literature, however, on topical cromolyn sodium for this disorder. Its use, however, has been somewhat controversial. Copied below is an abstract of a recent review, a reference indicating its lack of efficacy, and a reference indicating that it has been helpful. As in most treatments for atopic dermatitis, the literature is pediatric-based.

However, since I have never used cromolyn sodium in the therapy of atopic dermatitis, and have no familiarity with the literature until I received your inquiry, I am going to ask Dr. Donald Leung, who is an internationally known expert in this disorder, to share his thoughts with us about this issue. When I hear from Dr. Leung, I will forward his response to you.

Thank you again for your inquiry.

Int J Pharm Compd. 2012 Sep-Oct;16(5):386-93.
Topical use of sodium cromoglicate (cromolyn sodium) to treat atopic dermatitis and other skin allergies.
Zur E.
Source
Super-Pharm, Petach-Tikvah, Israel.
Abstract
Sodium cromoglicate (cromolyn sodium) is a very well-known medicine that has been used for many years for various allergic conditions. The topical use of this medicine is less known, and there are no commercial medicines of cream, gel, or lotion in most of the world. This article summarizes the clinical data accumulated from seventeen trials that checked the topical efficacy and safety of sodium cromoglicate and analyzes the clinical implementations of this medicine in the topical treatment of atopic dermatitis and other skin allergies. In addition, this article analyzes the various formulations that have been used in the clinical trials in an attempt to find the optimal formulation. The topical use of sodium cromoglicate seemed to have a promising potential, and implementing the data of this article can allow the compounding pharmacist a very interesting professional activity in very common and widespread allergic pathologies

Eur J Pediatr. 1988 Nov;148(2):170.
Failure of a new topical sodium cromoglycate formulation to improve atopic dermatitis.

Br J Dermatol. 2005 Feb;152(2):334-41.
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.
Stainer R, Matthews S, Arshad SH, McDonald S, Robinson J, Schapira C, Foote KD, Baird-Snell M, Gregory T, Pollock I, Stevens MT, Edwards AM.
Source
Synexus Limited, Crosby Clinical Research Centre, Burlington House, 3rd Floor, South Wing, Crosby Road North, Waterloo, Liverpool, UK.
Abstract
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.
Objectives: 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.

Sincerely,
Phil Lieberman, M.D.

We received a response from Dr. Donald Leung regarding your Ask the Expert inquiry.  Thank you again for your inquiry and we hope this response is helpful to you.
 
Sincerely,
Phil Lieberman, M.D.
 
Response from Dr. Donald Leung:
You are right on target - no good evidence that oral cromolyn is of any use in AD. It is poorly absorbed and unlikely can reach the skin through oral route.

Donald Leung

AAAAI - American Academy of Allergy Asthma & Immunology