Tag Archive for: pediatric contact dermatitis

T.R.U.E. Test (patch test) receives pediatric indication

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T.R.U.E Pediatric indication: T.R.U.E. Test (patch test) receives approval letter from Food and Drug Administration (FDA) for children 6 and older. After 12 years of investigations, evidence and data indicating that the patch testing is safe and efficacious in children suffering from recalcitrant dermatitis – the FDA has approved T.R.U.E Pediatric indication – the use of TRUE test to aid in the diagnosis of ACD in children.

This is the first commercially available patch test to receive approval for use in children 6 and older.  The T.R.U.E. test has 36 components, one is a negative control.

To read more about patch testing in children:

Article on Pediatric Allergic Contact Dermatitis.

“August 25, 2017

Dear Ms. Sullivan:
SUPPLEMENT APPROVAL PMR FULFILLED
August 25, 2017
We have approved your request dated October 26, 2016, to supplement your Biologics License Application submitted under section 351(a) of the Public Health Service Act (42 U.S.C. 262) for Thin-layer Rapid Use Epicutaneous Patch Test (T.R.U.E. TEST), to use as an aid in the diagnosis of allergic contact dermatitis in persons 6 years of age and older whose history suggests sensitivity to one or more of the 35 substances included on the T.R.U.E. TEST panels.”

FDA indication
Approval letter

pediatric patch test

Free Access for 30d! Inaugural Pediatric Contact Dermatitis Registry Data.

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New Today – 10 years in collaborative effort!  The inaugural data paper from the Pediatric Contact Dermatitis Registry (PCDR).   In the not too distant past it was believed that contact dermatitis (allergic) in children was rare, we now know that not to be the case as in fact it is an common in patch tested children as adults.  This study discusses the evaluation of more than 1000 US children who presented for evaluation of contact dermatitis.  The  reported here through a collaborative effort of more than 80 providers!  65% of the cases had a positive allergen and 48% were able to find at least on relevant source – remove the allergen and improve the dermatitis!!!

Goldenberg A1, Mousdicas N, Silverberg N, Powell D, Pelletier JL, Silverberg JI, Zippin J, Fonacier L, Tosti A, Lawley L, Wu Chang M, Scheman A, Kleiner G, Williams J, Watsky K, Dunnick CA, Frederickson R, Matiz C, Chaney K, Estes TS, Botto N, Draper M, Kircik L, Lugo-Somolinos A, Machler B, Jacob SE.  Pediatric Contact Dermatitis Registry Inaugural Case Data.  Dermatitis. 2016 Sep-Oct;27(5):293-302.

Abstract
BACKGROUND:
Little is known about the epidemiology of allergic contact dermatitis (ACD) in US children. More widespread diagnostic confirmation through epicutaneous patch testing is needed.
OBJECTIVE:
The aim was to quantify patch test results from providers evaluating US children.
METHODS:
The study is a retrospective analysis of deidentified patch test results of children aged 18 years or younger, entered by participating providers in the Pediatric Contact Dermatitis Registry, during the first year of data collection (2015-2016).
RESULTS:
One thousand one hundred forty-two cases from 34 US states, entered by 84 providers, were analyzed. Sixty-five percent of cases had one or more positive patch test (PPT), with 48% of cases having 1 or more relevant positive patch test (RPPT). The most common PPT allergens were nickel (22%), fragrance mix I (11%), cobalt (9.1%), balsam of Peru (8.4%), neomycin (7.2%), propylene glycol (6.8%), cocamidopropyl betaine (6.4%), bacitracin (6.2%), formaldehyde (5.7%), and gold (5.7%).
CONCLUSIONS:
This US database provides multidisciplinary information on pediatric ACD, rates of PPT, and relevant RPPT reactions, validating the high rates of pediatric ACD previously reported in the literature. The registry database is the largest comprehensive collection of US-only pediatric patch test cases on which future research can be built. Continued collaboration between patients, health care providers, manufacturers, and policy makers is needed to decrease the most common allergens in pediatric consumer products.

Full free access to the article for 30 days:

http://journals.lww.com/dermatitis/Abstract/2016/09000/Pediatric_Contact_Dermatitis_Registry_Inaugural.10.aspx