2013 Re: T.R.U.E Test and gold Dear Health Care Professional ...

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Study No. 10The study was a Phase 4 postmarketing open label, non-randomized, non-blinded prospective study including nine subjects. All subjects had previous positivepatch test results for Quaternium-15 (Q-15). The subjects were exposed to the T.R.U.E. TEST Q-15 patch at a concentration of 100 mcg/cm 2 and daily applicationsof a topical product containing Q-15 after the completion of the patch test. Reactions were evaluated 72 to 96 hours after application. T.R.U.E. TESTdetected Q-15 sensitivity in 87.50% (7/8) of the Q-15 allergic subjects while the topically applied lotion elicited a positive response in 50% (4/8) of the studypopulation. One subject tested negative to both methods of Q-15 and was removed from the endpoint analysis.Study DataTable 4 presents the frequency of positive reactions to T.R.U.E. TEST in consecutive subjects (subjects with a clinical history consistent with allergic contactdermatitis without a previous positive patch test reaction) for each allergen. The frequency of positive reactions to T.R.U.E. TEST in consecutive subjects andsensitive subjects (subjects with a previous positive patch test reaction to a specific allergen or allergens) for Quaternium-15 are presented in Table 4. Thesensitivity, specificity, and agreement estimate between each T.R.U.E. TEST allergen and the corresponding reference allergen (when used) are presented forconsecutive subjects and sensitive subjects (when done) in Table 4.Sensitivity was determined using the formula [TP / (TP + FN)] x 100, where TP (true positive) represented positive results for both the T.R.U.E. TEST allergenand the corresponding reference allergen, and FN (false negative) represented negative results for the T.R.U.E. TEST allergen and positive results for the correspondingreference allergen. Specificity was determined using the formula [TN / (TN + FP)] x 100, where TN (true negative) represented negative results for45
oth the T.R.U.E. TEST allergen and the corresponding reference allergen, and FP (false positive) represented positive results for the T.R.U.E. TEST allergen andnegative results for the corresponding reference allergen. The agreement estimate (with 95% confidence intervals), as well as overall percent agreement andCohen’s kappa statistic between the test site skin reactions obtained for each of the seven T.R.U.E. TEST Panel 3.2 allergens and the test site skin reactionsobtained for their associated reference allergens in petrolatum or ethanol were calculated for all subjects combined, as well as for the populations of sensitiveand consecutive subjects.Table 4- Available Frequency, Sensitivity, Specificity, and Agreement Estimate of T.R.U.E. TEST AllergensPanel 1.2Nickel sulfate* Position 1 (Studies 1, 3, 4 and 9)Frequency from consecutive subjects only (%) 90/345 (26.1)46
Page 1 and 2: 2013Re: T.R.U.E Test and goldDear H
Page 3 and 4: Will patients have a late or persis
Page 6 and 7: T.R.U.E. TESTThin-Layer Rapid Use E
Page 8 and 9: DOSAGE AND ADMINISTRATIONApply the
Page 10 and 11: FULL PRESCRIBING INFORMATION: CONTE
Page 12 and 13: T.R.U.E. Test panels should be appl
Page 14 and 15: 2.2 Timing of Test ReadingsSchedule
Page 16 and 17: 5. WARNINGS AND PRECAUTIONS5.1 Acut
Page 18 and 19: 5.9 Repeat TestingThe safety and ef
Page 20 and 21: Clinical Study OverviewStudy1Study2
Page 22 and 23: Clinical Study OverviewStudy1Study2
Page 24 and 25: Table 2- Summary of Adverse Reactio
Page 26 and 27: Panel Adhesion: Problems with panel
Page 28 and 29: 7.3 Systemic GlucocorticoidsOral st
Page 30 and 31: Each test consists of the following
Page 32 and 33: Potassium Dichromate (Position 4):P
Page 34 and 35: in equal parts (purity of each deri
Page 36 and 37: cellulose. This patch is formulated
Page 38 and 39: p-Phenylenediamine (Position 20):p-
Page 40 and 41: thiuram disulfide, 5 mcg of disulfi
Page 42 and 43: Hydrocortisone-17-Butyrate (H-17-B)
Page 44 and 45: lergen is presented to helper T-lym
Page 46 and 47: Study No. 3This study evaluated the
Page 48 and 49: Study No. 7This study evaluated the
Page 52 and 53: Wool alcohols (Lanolin)* Position 2
Page 54 and 55: Balsam of peru* Position 10 (Studie
Page 56 and 57: Black rubber mix* Position 16 (Stud
Page 58 and 59: Methyldibromo glutaronitrile (MDBGN
Page 60 and 61: Panel 3.2Diazolidinyl urea (DU) (Ge
Page 62 and 63: Quinoline mix* Position 26 (Studies
Page 64 and 65: Gold sodium thiosulfate (GST) Posit
Page 66 and 67: Imidazolidinyl urea (IMID) (Germall
Page 68 and 69: Budesonide (BUD) Position 30 (Study
Page 70 and 71: Hydrocortisone-17-butyrate (H-17-B)
Page 72 and 73: Mercaptobenzothiazole* Position 32
Page 74 and 75: Parthenolide Position 34 (Study 8)P
Page 76 and 77: Disperse blue 106 (DB106) Position
Page 78 and 79: 2-Bromo-2-nitropropane-1,3-diol (Br
Page 80 and 81: 16. HOW SUPPLIED/STORAGE AND HANDLI
Page 85: Manufactured by SmartPractice Denma

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