An Evaluation

Paolo Pigatto, Andrea

of the Allergic Contact Dermatitis of Colloidal Grain Suspensions

Bigardi, Ruggero Caputo, Giovanni Angelini, and Ronald L. Rizer Caterina

Potential
Grandolfo,

Foti, Mauro

Background: Colloidal grain suspensions have been used for decades as adjuncts in the treatment of atopic dermatitis, especially in the US. In Italy, many young children have been exposed to colloidal grains. Recently, it was suggested that these bath therapies may induce allergic contact dermatitis in some young atopic children. Objective: To evaluate the allergic skin reactions to oat and rice colloidal grain suspensions of normal and atopic children with and without previous exposure to colloidal grain suspensions. Methods: A double-blind, randomized patch study. Two concentrations of oat and rice colloidal grains (0.007% and 0.7%) were applied occlusively to the backs of 65 children living in Italy, ages 6 months to 2 years (43 were atopic and 22 were normal). Results: There were neither immediate urticarial nor allergic reactions in any of the 65 study

subjects, atopic or nonatopic; 5 of 43 (12%) atopic subjects developed irritant reactions to the test materials. Radioallergosorbent tests (RAST) tests were performed on 55 subjects. The negative RAST test results found in the nonatopic group correlated well with nonatopic status, but positive RAST tests were found in only 8 of 35 (23%) atopic dermatitis subjects. None of the sera from positive RAST scores corresponded to subjects with irritant patch reactions. Conclusions: The data indicate that topical colloidal grains can be used as an adjunct in the management of mild atopic dermatitis in children under 2 years of age. There was no evidence of sensitization to topical colloidal grains in the group studied. Copyright o 1997 by W.B. Saunders Company

OLLOIDAL grain suspensions, especially oats, have been used for more than 40 years as adjuncts in the treatment of atopic dermatitis.,2 Recent data have suggested that these natural bath remedies may occasionally cause reactions in some young atopic children with previous exposure to colloidal grains.3 Also, unpublished patch studies on young children with severe atopic dermatitis showed a 5% positive patch response to Oilated Aveeno Bath (Rydelle Laboratories, Johnson Wax, Milan, Italy) (R. Caputo, unpublished data). The purpose of this multicenter, doubleblind, controlled, clinical study was to evaluate the potential reactions to two types of colloidal grain suspensions (oats and rice) of normal and atopic children with and without previous exposure to colloidal grain suspensions.

preceding previous

the start exposure.

of the study), Twenty-two

and

13, who were

had no known includ-

children

nonatopic,

ing 11 who had previous exposure to topical colloidal grains, and 11 who had no known previous exposure. Atopic dermatitis cases were classified according scale (mildly effected).l IgE antibody radioallergosorbent to the O-4 Rajka and Langeland range

reactivity was assessed to grain extracts by tests (RAST). Atopic children discontinued

the use of oral or topical anti-inflammatory medications 1 week before their first clinic visit and for the duration of the study. Topical emollients were permitted the patch test areas on their backs. during this time, but not on

Patch Test Design

Two sets of nine AI-Test patch test chambers were loaded with 50 uL of each of the test materials listed in Table 1. assess Two concentrations oftest materials the contact dermatitis potential: were chosen to help 0.007% simulates a treatment; 0.7% an exaggerated

concentration that would be typical (loo-fold increase in concentration)

of a bath represents

MATERIALS

AND

METHODS

case of very high concentration of colloidal grain (paste). All eight grain samples were supplied to the study centers premeasured, dry, and in sealed, blind-labeled pouches. The test materials were identified by random numbers, and neither the clinical investigator nor the patch test reader knew the code. A set of eight patch test solutions was prepared immediately

Twenty-five children were enrolled at the Milano study center, and 40 children were enrolled at the Bari study center (65 subjects total) between October 1992 and February 1994. These children were between the ages of 6 months and 2 years. preliminary specific age This age group data3 indicated was selected because the recent possible allergic reactions in this

group and that experience in clinical practice established the appearance of atopic dermatitis as beginning in this age group. This was a double-blind, randomized patch study using standardized procedure guidelines of the International Contact Dermatitis Research Group. Forty-three children were atopic, including 30 who had previous exposure to topical colloidal grains (at least three times per week for the 3-month period

From Istituto di Dematologia, Sczenz Dermatologiche e Dematologia

Uniuenitd Pediatrica,

di Milmo; Istituto di Ulzivenitii di M&ma, di Bari, Bari, It&; of

M&m, It&; Clinica Dermatologica, Uniuersitii and Stephem &Associates In, Dallas, TX.

Address reprint requests to Paolo Pigatto, MD, Institute Dermatolo~, Unioersi& ofMilan, iris Pace 9, I-20122 Milano, It&. Coflyright 0 1997Ly W.B. Saunders Company 1046-1!?9xl97/0804-0003~3.00/0

American

Journal

of Contact

Dermatitis,

Vol8,

No 4 (December),

1997: pp 207-209

207

208

PIGATTO

ET AL

Table
Material

1. Test Materials Concentration

Doseage

Aveeno

Bath Italy)* Italy)* 0.007% 0.7% 0.007% 0.7% 0.007% 0.7% 0.007% 0.7% to (Control) composition: Avena sativa, Avena citric Sativa, calcium acid, citric sili(Low (High (Low Dose) Dose)

(Rydelle, Milan, Aveeno Bath (Rydelle, Milan,

was used to estimate the range ofincidence probabilities that are consistent with the observed data.7 Differences in exposure history, medical history or presence of allergies were compared using a 2 by 4 chi-square test. A one-way analysis ofvariance was used to compare the only continuous variable, ie, age.

Aveeno Bath Oilated (Rydelle, Milan, Italyjt Aveeno Bath Oilated (Rydelle, Milan, ItalyIt Colloidal Colloidal Colloidal Colloidal Distilled dilute rice flour rice flour oat flour oat flour water (used of materials) Bath

RESULTS
Dose)

(High Dose) (Low Dose) (High Dose)

(Low Dose)
(High Dose)

Aveeno sodium

bicarbonate, dimethicone. tAveeno Bath Oilated composition: sodium

acid, paraffinurn liquidum, cate, laureth-4, dimethicone.

bicarbonate,

before application to the patch test chambers by adding distilled water (250 mL) to each pouch. The samples were shaken until uniformly suspended, and each test solution (50 uL) was applied to the filter paper disk inside the aluminium patch chamber. Two sets of occluded patch test samples and one set of open patch samples were applied to randomized patch test sites on the back of each subject beginning at the upper left back and finishing at the lower right back. To test for immediate wheeling response, each test solution (50 uL) was applied in an open patch application. After 15 minutes, the opened patch sites were observed, and if no urticarial response was observed, the two sets of occluded patches were applied, and were worn for 24 hours. If a positive response was observed at the 24.hour interval, the corresponding contralateral patch was removed. If no reaction was observed, the corresponding contralateral patches remained in place for an additional 24 hours, and were read at the 48-hour interval. All sites were also read at 72 and 96 hours.

Table 2 illustrates the atopic and colloidal grain exposure incidence in the patient population, allergy symptoms, and regular use of skin cleansing products. Within the first 15 minutes of open patch administration, there were no responses of contact urticaria. At 24 hours, one atopic subject with previous exposure to topical colloidal grains developed an irritant reaction to 0.7% oilated that vanished in the following controls. At 48 hours of exposure, there were four mild irritant responses (only faint erythema) in the patients of the atopic group that had previous exposure to colloidal grains. Two of these reactions were to Aveeno bath solution, 0.007%; one was to rice solution, 0.007%; and one was to oat flour, 0.7%. There were no allergic reactions in any of the 65 study subjects. RAST tests were performed on 55 of the 65 patients enrolled in the study. Of the 55 patients evaluated, 8 showed a positive response to one or more of the RAST test substances. All eight who showed a positive response to the RAST test were atopic, but none of those subjects had corresponding patch test responses. DISCUSSION Many children in Italy have been exposed to topical colloidal grains as part of their regular bath product usage. Recent clinical experience in the dermatologic clinic in Milan suggested that young
and Key Variables Nonatopic
Exposure No Exposure Exposure P VdLle

Statistical Ana(ysti
To estimate the confidence intervals for the incidence rates of irritant and contact dermatitis, an exact binomial model
Table 2. Patient Histories

Atopic
No Exposure

Number Age* Eczema Wheeze Cold symptoms (rhinitis-laryngitis-pharyingitis) Hayfever Allergies to medications

13 1.5 (.9) 100% 7.7% 0.0% 23.1% 0.0% anti-inflammatory drug.

30 2.0 (1.1) 89.7% 13.8% 31 .O% 41.4% 18.8%

11 1.5 (1.0) 0% 0.0% 0.0% 9.1% 0.0%

11 1.6 (1.2) 0.0% 3.1% 36.4% 0.0% 0.0% Not Sig. <O.OOl Not Sig. 0.01 Not Sig. Not Sig.

(NSAID-antibiotics) Abbreviation: NSAID, nonsteroidal *Mean (Standard Deviation).

COLLOIDAL

GRAIN

SUSPENSION

ALLERGY

209

atopic children may have a higher incidence of sensitization to topical colloidal grain exposure.4 Neither immediate urticarial reactions nor allergic reactions occurred in this study. However, irritant reactions occurred in 5 of 43 (12%) atopic subjects. Of the 55 subjects who had RAST tests performed on their sera to oat, rye, barley, triticum, wheat, and corn, 8 showed a positive response to one or more of the natural grains. All 8 were atopic, but none had corresponding allergic or irritant patch test reactions. Therefore, RAST test results did not predict patch test responses to Aveeno bath products or to oats. In conclusion, our data indicate that topical colloidal grains can be used as an adjunct in the

management of mild atopic dermatitis in children under 2 years of age. There was no evidence of sensitization to topical colloidal grains in the group studied.

ACKNOWLEDGMENT We thank E.T. Lance-Gomez, PhD, Raymond G. Hoffmann, PhD, and John C. Seitz, PAC for valuable assistance in the conduct and evaluation of results of this study. We are indebted to Jon Han&, MD and L. Boyd Savoy, MD for helpful suggestions during the planning phase of this research.

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D, Quan H: Exact confiStatistician 39:391-393, (8th

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144~13-14,

1990 Nutrition, Centers for Disease Control, Atlanta, GA 7. Snedecor GW, Cochran WG: Statistical Methods ed). Iowa State University Press, Ames, IA, 1986

@PPC

THE ATOPY

Held on the occasion University Hospital Zurich, Immunology. For more information, please contact Prof. Dr. B. Wiithrich, Zurich, Gloriastrasse 3 1, CH 809 1 Zurich, Switzerland.

SYNDROME IN THE THIRD MILLENNIUM October Z-3,1998 Zurich, Switzerland of the 50fh anniversary of the allergy unit in the Department of Dermatology, and in collaboration with the European Academy of Allergology and Clinical Department of Dermatology, University of