TRUE Test Side Effects Center

Last updated on RxList: 7/11/2022
TRUE Test Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is TRUE Test?

T.R.U.E. Test (Thin-Layer Rapid Use Epicutaneous patch test) is an epicutaneous (on the skin) patch test indicated for 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 allergens and allergen mixes included on the T.R.U.E. TEST panels.

What Are Side Effects of TRUE Test?

Common side effects of T.R.U.E. Test include:

  • skin burning,
  • tape irritation,
  • persistent reactions,
  • redness,
  • skin discoloration itching,
  • worsening of pre-existing dermatitis,
  • skin infections,
  • skin reactions near a panel site, and
  • acute allergic reactions (including anaphylaxis)

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for TRUE Test

Apply the three T.R.U.E. Test adhesive panels of allergens and allergen mixes on healthy skin of the back. Remove panels and evaluate the skin 48 hours after application. Re-evaluate the skin 72 to 96 hours after application. T.R.U.E.

What Drugs, Substances, or Supplements Interact with TRUE Test?

Test may interact with systemic or topical immunosuppressant therapy and oral steroids. Tell your doctor all medications and supplements you use.

TRUE Test During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using T.R.U.E. Test; it is unknown how it would affect a fetus. It is unknown if T.R.U.E. Test passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our T.R.U.E. Test (Thin-Layer Rapid Use Epicutaneous patch test) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Allergies can best be described as: See Answer
TRUE Test Professional Information

SIDE EFFECTS

In adults 18 years of age and older, the most common (occurring in >1% of the study population) adverse reactions were burning (25.4%), tape irritation (15.8%), persistent reactions (6.8%), erythema (5.7%), and hyper/hypopigmentation (4.9%). In children and adolescents 6 through 17 years of age, the most common (occurring in >1% of the study population) adverse reactions were itching (up to 61.2%), tape irritation (up to 50.0%), persistent reactions (4.6%), ectopic flare of pre-existing dermatitis (12.8%), burning (up to 10.5%), skin infections (1.8%), and skin reactions near a panel site (1.4%).

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug may not reflect the rates observed in clinical practice.

Adult Subjects 18 Years Of Age And Older

Table 1 presents a summary of ten clinical trials conducted in adults in North America and Europe using T.R.U.E. TEST.

Table 1: Overview of Clinical Studies using T.R.U.E. TEST Among Adults 18 Years of Age and Older

Clinical Study Overview Study 1 Study 2 Study 3 Study 4 Study 5 Study 6 Study 7 Study 8 Study 9 Study 10 Total
N   127 121 119 50 130 128 200 235 49 9 1168
Age Range (years)   19-79 18-77 19-76 19-82 19- 86 20-83 19-78 18-85 18-68 36-76 18- 86
Sex (% female)   68% 68% 73% 72% 68% 63% 59% 71% 98% 78% 69%
Ethnicity Caucasian 86% 88% 83% 92% 85% 88% 97% 91% 98% 100% 83%
  Black 9% 12% 11% 4% 13% 12% 0% 5% 0% 0% 9%
  Other 5% 1% 6% 4% 2% 0.8% 3% 4% 2% 0% 7%
Allergens Nickel sulfate X   X X         X    
  Wool alcohols   X X X              
  Neomycin sulfate X   X X         X    
  Potassium dichromate X   X X         X    
  Caine Mix X   X X         X    
  Fragrance Mix X   X X         X    
  Colophony X   X X         X    
  Paraben Mix   X X X              
  Balsam of Peru X   X X         X    
  Ethylenediamine dihydrochloride X   X X         X    
  Cobalt dichloride X   X X         X    
  p-tert-Butylphenol formaldehyde resin   X X X              
  Epoxy resin X X X         X    
  Carba mix   X X X              
  Black rubber mix   X X X              
  Cl+ Me-Isothiazolinone   X X X              
  Quaternium-15   X X X           X  
  Methyldibromo glutaronitrile               X      
  p-Phenylenediamine X   X X         X    
  Formaldehyde     X X              
  Mercapto Mix   X X X              
  Thimerosal   X X X              
  Thiuram Mix X   X X         X    
  Diazolidinyl urea         X            
  Quinoline Mix   X X X              
  Tixocortol-21-pival ate           X X        
  Gold Sodium Thiosulfate               X      
  Imidazolidinyl urea         X            
  Budesonide           X X        
  Hydrocortisone-17- butyrate             X X      
  Mercaptobenzothiazole   X X X              
  Bacitracin               X      
  Parthenolide               X      
  Disperse blue 106               X      
  Bronopol               X      

Table 2 summarizes the adverse reactions recorded in ten clinical studies. Subjects' adverse reactions were recorded on case report forms by study personnel. Adverse reactions were recorded during subject follow-up visits, which varied between 24 and/or 96 hours and/or Day 21 [see Clinical Studies].

Table 2: Summary of Adverse Reactions Reported Among Adult Subjects 18 Years of Age and Older

  Study 1 Study 2 Study 3 Study 4 Study 5 Study 6 Study 7 Study 8 Study 9 Study 10 Total (%)
N 127 121 119 50 130 128 200 235 49 9 1168
Burning* 12 6 9 16 50 51 25 123 5 0 297 (25.4)
Tape Irritation* 4 0 2 1 22 51 25 79 0 0 184 (15.8)
Persistent Reactions† 11 0 0 8 2 16 1 41 0 0 79 (6.8)
Erythema† 0 3 27‡ 2 0 3 0 32 0 0 67 (5.7)
Hyper/Hypopigmentation† 11 2 8‡ 6 1 7 0 14 8 0 57 (4.9)
Sensitization (possible)† 0 2 5‡ 1 0 0 0 ND ND ND 8 (0.9)§
Late Reaction† 0 0 0 1 0 0 0 7 0 0 8 (0.7)
Scarring† 0 0 2‡ ND ND ND ND ND ND ND 2 (0.5)§
Ectopic Flare† ND ND ND ND 1 0 1 ND ND ND 2(0.4)§
ND=Not Done
* Reported at 4 8 hours
† Reported during follow up visit at Day 21
‡ Reported during follow up (4 to 80 days).
§ n and % are based on the N of the studies where this data was collected.

Panel Adhesion

Problems with panel adhesion were observed during some of the clinical studies. Poor panel adhesion was defined as any panel that fell off prior to the 48-hour removal time, any test panel that was not in good contact with the skin, or if one or more of the patch test allergens were not in good contact with the skin as evidenced at the time of panel removal, 48 hours. If the panel fell off the back prior to the 48-hour removal time frame, the subject was excluded from the efficacy calculations (sensitivity and specificity) but not from the safety analysis. Over all studies, poor panel adhesion occurred 49 times (4.2%) (Table 3). In study 2, the poor adhesion was attributed to the particular lot of adhesive used to manufacture the clinical test tape.

Table 3: Incidence and Proportion of Poor Panel Adhes ion Among Subjects 18 Years of Age and Older

  Study 1 Study 2 Study 3 Study 4 Study 5 Study 6 Study 7 Study 8 Study 9 Study 10 Total
N 127 121 119 50 130 128 200 235 49 9 1168
Poor Adhesion (%) 0 (0.0) 14 (11.6) 2 (1.7) 5(10.0) 1 (0.8) 1 (0.8) 0 (0.0) 10 (4.3) 12 (23.5) 0 (0.0) 49 (4.2)

Children And Adolescents 6 Through 17 Years Of Age

The safety of T.R.U.E. TEST in children and adolescents 6 through 17 years of age was evaluated in two open-label studies conducted in the US. In these studies, children and adolescents with suspected allergic contact dermatitis had three T.R.U.E. TEST panels applied to their backs and upper arms by investigators. Some of the panels were from previously approved versions of T.R.U.E. TEST. Subjects were instructed to keep the panels in place for 48 hours. Subjects were monitored for safety for 21 days after application of T.R.U.E. TEST panels. The safety monitoring plan included investigator's assessment of panel adhesion, tape irritation, and participant reporting of burning and itching (as a combined symptom) when panels were removed 2 days after application of T.R.U.E. TEST. Surveillance for late reactions, possible sensitization and persistent reactions occurred at Day 7 and 21. Unsolicited adverse events, serious adverse events and deaths were monitored for 21 days after patch application.

Pediatric Study 1 (NCT: 00795951)

In this prospective, single-center, open label study, 102 subjects were enrolled to evaluate the safety of T.R.U.E. TEST [see Clinical Studies Table 7 for a list of the allergens and allergen mixes]. Of enrolled subjects, 52% were female, 39.2% were White, 31.4% were Hispanic, 6.9% were Black, 12.7% were Asian and 10.5% were of other racial/ethnic groups. The mean age of subjects was 11.6 years.

Pediatric Study 2 (NCT: 01797562)

In a prospective, multi-center, open-label study conducted in the US, up to 116 children and adolescents were enrolled to evaluate the safety of T.R.U.E. TEST [see Clinical Studies Table 7 for a list of the allergens and allergen mixes]. Of enrolled subjects, 69% were female, 37.9% were Hispanic or Latino, 28.5% were White, 11.2% were Asian, 6.0% were Black, and 16.4% were of other racial/ethnic groups. The mean age of subjects was 12.6 years. Table 4 summarizes adverse reactions occurring within 21 days after T.R.U.E. TEST application.

Table 4: Pediatric Study 2* : Adverse Reactions Occurring 2 Days after T.R.U.E. TEST Application in Children and Adolescents 6 through 17 Years of Age

Adverse Reactions Any
n (%)
Severe n (%)
Panel 1.3
N=54†
Panel 2.3
N=114‡
Panel 3.3
N=114
Panel 1.3
N=54
Panel 2.3
N=114
Panel 3.3
N=114
Itching§ 31 (57.4) 62
(54.4)
72 (63.2) 1 (1.9) 7 (6.1) 11 (9.7)
Burning§ 3 (5.6) 7 (6.1) 12 (10.5) 0 (0.0) 0 (0.0) 1 (0.9)
Tape irritation¶ 27 (50.0) 56 (49.1) 53 (46.5) 0 (0.0) 1 (0.9) 0 (0.0)
*NCT: 01797562
† Fifty five subjects received Panel 1.3 and 61 subjects received Panel 1.2, which included 4 allergens with outdated formulations. Fifty four of the 55 subjects presented on day 2 as scheduled.
‡ Of the 116 subjects who received T.R.U.E. TEST, 114 presented to visit 2 and had itching, burning, and tape irritation data documented.
§ Itching and burning were graded as none, mild/weak (minimal discomfort), moderate (definite discomfort), or severe (significantly bothersome, possible interference with sleep or daily activity).
¶ Tape irritation was graded at Day 2 by investigators using a 4 -point scale, including none, weak (faint to definite pink erythema), moderate (moderate erythema, definite redness), or severe (severe erythema, very intense redness).

Across both pediatric studies (N=218), extreme positive reactions (+++, indicating a bullous or ulcerative reaction with pronounced erythema, infiltration, and coalescing vesicles) occurred in two subjects. Both extreme positive reactions occurred in response to metal allergens (nickel sulfate and gold sodium thiosulfate) by Day 3 and resolved by Day 21. Late positive reactions occurred in 2 subjects (0.9%) 21 days after T.R.U.E. TEST application to the following allergen: gold sodium thiosulfate (n=2). Persistent reactions occurred in 10 subjects (4.6%) 21 days after T.R.U.E. TEST application to the following allergens: bronopol (n=1), Cl+Me+isothiazolinone (n=1), diazolidinyl urea (n=1), gold sodium thiosulfate (n=6), nickel sulfate (n=2), and quaternium-15 (n=1). Ectopic flare of preexisting dermatitis occurred in 28 (12.8%) of subjects. Of these cases, 1 (0.5%) was severe and 3 (1.4%) were complicated by skin infection. Skin reactions near a panel site were observed in 3 subjects (1.4%). No serious adverse events or deaths considered related to T.R.U.E. TEST occurred.

Panel Adhesion

In Pediatric Study 2, poor panel adhesion was observed in up to 11.3% of subjects who received T.R.U.E. TEST panels. Panel(s) fell off in up to 3.6% of participants in Pediatric Study 2.

Postmarketing Experience

The following additional adverse reactions have been identified during post-approval use of T.R.U.E. TEST. Because these reactions are continuously reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to T.R.U.E. TEST exposure.

  • Acute allergic reactions [see WARNINGS AND PRECAUTIONS]
  • Extreme positive reactions [see WARNINGS AND PRECAUTIONS]
  • Excited skin syndrome (Angry back) [see WARNINGS AND PRECAUTIONS]
  • Irritant contact dermatitis [see WARNINGS AND PRECAUTIONS]

Read the entire FDA prescribing information for TRUE Test (Thin-layer Rapid Use Epicutaneous Patch Test for Topical Use Only)

SLIDESHOW

Could I Be Allergic? Discover Your Allergy Triggers See Slideshow

© TRUE Test Patient Information is supplied by Cerner Multum, Inc. and TRUE Test Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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