Trial Outcomes & Findings for Clinical Evaluation of T.R.U.E. Test Allergens in Children an Adolescents (NCT NCT01797562)

Last Updated: 2020-08-21

Results Overview

Reactions at patch test sites were evaluated:Negative: No reaction, Irritant: Discrete, patchy, follicular, or homogenous erythema with no infiltration, Doubtful: Faint macular or homogenous erythema with no infiltration, 1+: Faint macular or homogenous erythema with no infiltration, 2+: Erythema, papules, infiltration, discrete vesicles 3+: Coalescing vesicles, bullous reaction

Recruitment status

COMPLETED

Study phase

Target enrollment

116 participants

Primary outcome timeframe

Investigator Determination of Positive Reaction: 21 days post application

Results posted on

2020-08-21

Participant Flow

Subjects will be recruited from patients visiting dermatology, allergy or similar medical practices and clinics, and who are likely to require diagnostic patch testing. Study subjects must be otherwise healthy, and fulfill entry criteria.

Entry criteria required avoidance of systemic or topical (near the test area) corticosteroid treatment during the 7 days prior to patch application, and any treatment with UV light for 3 weeks prior to patch application.

Participant milestones

Participant milestones
Measure	Evaluation of T.R.U.E. Test Experimental Allergens 11 experimental patch test allergens:0.60mg/cm2 neomycin, 0.054 mg/cm2 potassium dichromate, 0.50 mg/cm2 fragrance mix, 0.050 mg/cm2 ethylenediamine, 0.075 mg/cm2 gold,0.020 mg/cm2 hydroxycortisone, 0.60 mg/cm2 bacitracin, 0.0030 mg/cm2 parthenolide,0.050 mg/cm2 disperse blue and 0.25 mg/cm2 bronopol were applied to the skin for 48 hours.
Overall Study STARTED	116
Overall Study COMPLETED	111
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Evaluation of T.R.U.E. Test Experimental Allergens 11 experimental patch test allergens:0.60mg/cm2 neomycin, 0.054 mg/cm2 potassium dichromate, 0.50 mg/cm2 fragrance mix, 0.050 mg/cm2 ethylenediamine, 0.075 mg/cm2 gold,0.020 mg/cm2 hydroxycortisone, 0.60 mg/cm2 bacitracin, 0.0030 mg/cm2 parthenolide,0.050 mg/cm2 disperse blue and 0.25 mg/cm2 bronopol were applied to the skin for 48 hours.
Overall Study Protocol Violation	5

Baseline Characteristics

Clinical Evaluation of T.R.U.E. Test Allergens in Children an Adolescents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Positive Response Rates: 7 New and 4 Reformulated Allergens n=116 Participants Subjects will be patched with TRUE Test Panels 1.3, 2,2 and 3.2. Panel 1 allergens nickel sulfate (0.60 mg/cm2), potassium dichromate (0.054 mg/cm2), fragrance mix (0.050 mg/cm2) and ethylenediamine dihydrochloride (0.050 mg/cm2), Panel 2 allergen Methyldibromoglutaronitrile (0.0053 mg/cm2) and Panel 3 allergens Gold sodium thiosulfate (0.075 mg/cm2), Hydrocortisone-17-butyrate (0.020 mg/cm2), Bacitracin (0.60 mg/cm2), Parthenolide (0.0030 mg/cm2), Disperse blue 106 (0.050 mg/cm2 in PVP), 2-Bromo-2-nitropropane-1,3-diol (Bronopol) (0.25 mg/cm2) will be evaluated Panels 1.3, 2.2 and 3.2 experimental allergens: Three allergen panels will be applied to the upper backs of study subjects and will be worn for 48 hours. Allergen test sites will be evaluated at 3, 4, 7(±1) and 21(±2) days post application.
Age, Continuous	12.6 years n=5 Participants
Sex: Female, Male Female	80 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	72 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	13 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	78 Participants n=5 Participants
Race (NIH/OMB) More than one race	12 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Region of Enrollment United States	116 participants n=5 Participants

PRIMARY outcome

Timeframe: Investigator Determination of Positive Reaction: 21 days post application

Outcome measures

Outcome measures
Measure	Positive Response Rates: 7 New and 4 Reformulated Allergens n=111 Participants Subjects will be patched with TRUE Test Panels 1.3, 2,2 and 3.2. Panel 1 allergens nickel sulfate (0.60 mg/cm2), potassium dichromate (0.054 mg/cm2), fragrance mix (0.050 mg/cm2) and ethylenediamine dihydrochloride (0.050 mg/cm2), Panel 2 allergen Methyldibromoglutaronitrile (0.0053 mg/cm2) and Panel 3 allergens Gold sodium thiosulfate (0.075 mg/cm2), Hydrocortisone-17-butyrate (0.020 mg/cm2), Bacitracin (0.60 mg/cm2), Parthenolide (0.0030 mg/cm2), Disperse blue 106 (0.050 mg/cm2 in PVP), 2-Bromo-2-nitropropane-1,3-diol (Bronopol) (0.25 mg/cm2) will be evaluated Panels 1.3, 2.2 and 3.2 experimental allergens: Three allergen panels will be applied to the upper backs of study subjects and will be worn for 48 hours. Allergen test sites will be evaluated at 3, 4, 7(±1) and 21(±2) days post application.
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Neomycin sulfate · Negative	49 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Neomycin sulfate · Positive	3 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Neomycin sulfate · Irritant	0 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Neomycin sulfate · Doubtful	1 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Neomycin sulfate · Not Tested with this Allergen	58 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Potassium dichromate · Negative	50 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Potassium dichromate · Positive	2 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Potassium dichromate · Irritant	0 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Potassium dichromate · Doubtful	1 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Potassium dichromate · Not Tested with this Allergen	58 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Fragrance Mix · Negative	48 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Fragrance Mix · Positive	2 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Fragrance Mix · Irritant	0 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Fragrance Mix · Doubtful	3 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Fragrance Mix · Not Tested with this Allergen	58 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Ethylenediamine · Negative	53 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Ethylenediamine · Positive	0 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Ethylenediamine · Irritant	0 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Ethylenediamine · Doubtful	0 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Ethylenediamine · Not Tested with this Allergen	58 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores MDBGN · Negative	107 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores MDBGN · Positive	1 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores MDBGN · Irritant	0 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores MDBGN · Doubtful	3 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores MDBGN · Not Tested with this Allergen	0 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Gold · Negative	69 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Gold · Positive	31 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Gold · Irritant	0 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Gold · Doubtful	11 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Gold · Not Tested with this Allergen	0 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Hydrocortisone · Negative	106 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Hydrocortisone · Positive	2 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Hydrocortisone · Irritant	0 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Hydrocortisone · Doubtful	3 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Hydrocortisone · Not Tested with this Allergen	0 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Bacitracin · Negative	90 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Bacitracin · Positive	16 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Bacitracin · Irritant	0 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Bacitracin · Doubtful	5 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Bacitracin · Not Tested with this Allergen	0 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Parthenolide · Negative	97 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Parthenolide · Positive	7 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Parthenolide · Irritant	0 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Parthenolide · Doubtful	7 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Parthenolide · Not Tested with this Allergen	0 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Disperse Blue · Negative	102 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Disperse Blue · Positive	4 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Disperse Blue · Irritant	0 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Disperse Blue · Doubtful	5 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Disperse Blue · Not Tested with this Allergen	0 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Bronopol · Negative	89 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Bronopol · Positive	19 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Bronopol · Irritant	0 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Bronopol · Doubtful	3 Participants
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores Bronopol · Not Tested with this Allergen	0 Participants

SECONDARY outcome

Timeframe: Day 7-21

Population: Per protocol population consisted of all subjects who were applied with all panels, whose panels remained in place for approximately 48 hours and returned for all visits.

Late reactions are positive reactions that initially occur at 7-21 days after application of the panels. Persistent reactions are positive reactions that persist from one visit to the next. Numbers reported only include late or persistent positive patch test reactions. Not all positive reactions are late or persistent.

Outcome measures

Outcome measures
Measure	Positive Response Rates: 7 New and 4 Reformulated Allergens n=111 Participants Subjects will be patched with TRUE Test Panels 1.3, 2,2 and 3.2. Panel 1 allergens nickel sulfate (0.60 mg/cm2), potassium dichromate (0.054 mg/cm2), fragrance mix (0.050 mg/cm2) and ethylenediamine dihydrochloride (0.050 mg/cm2), Panel 2 allergen Methyldibromoglutaronitrile (0.0053 mg/cm2) and Panel 3 allergens Gold sodium thiosulfate (0.075 mg/cm2), Hydrocortisone-17-butyrate (0.020 mg/cm2), Bacitracin (0.60 mg/cm2), Parthenolide (0.0030 mg/cm2), Disperse blue 106 (0.050 mg/cm2 in PVP), 2-Bromo-2-nitropropane-1,3-diol (Bronopol) (0.25 mg/cm2) will be evaluated Panels 1.3, 2.2 and 3.2 experimental allergens: Three allergen panels will be applied to the upper backs of study subjects and will be worn for 48 hours. Allergen test sites will be evaluated at 3, 4, 7(±1) and 21(±2) days post application.
Number of Participants With Late or Persistent Positive Patch Test Reactions Neomycin sulfate · Persistent Reactions	2 Participants
Number of Participants With Late or Persistent Positive Patch Test Reactions Neomycin sulfate · Late Reactions	1 Participants
Number of Participants With Late or Persistent Positive Patch Test Reactions Neomycin sulfate · Neither	108 Participants
Number of Participants With Late or Persistent Positive Patch Test Reactions Potassium dichromate · Persistent Reactions	0 Participants
Number of Participants With Late or Persistent Positive Patch Test Reactions Potassium dichromate · Late Reactions	1 Participants
Number of Participants With Late or Persistent Positive Patch Test Reactions Potassium dichromate · Neither	110 Participants
Number of Participants With Late or Persistent Positive Patch Test Reactions Fragrance mix · Persistent Reactions	2 Participants
Number of Participants With Late or Persistent Positive Patch Test Reactions Fragrance mix · Late Reactions	0 Participants
Number of Participants With Late or Persistent Positive Patch Test Reactions Fragrance mix · Neither	109 Participants
Number of Participants With Late or Persistent Positive Patch Test Reactions Ethylenediamine · Persistent Reactions	0 Participants
Number of Participants With Late or Persistent Positive Patch Test Reactions Ethylenediamine · Late Reactions	0 Participants
Number of Participants With Late or Persistent Positive Patch Test Reactions Ethylenediamine · Neither	111 Participants
Number of Participants With Late or Persistent Positive Patch Test Reactions MDBGN · Persistent Reactions	0 Participants
Number of Participants With Late or Persistent Positive Patch Test Reactions MDBGN · Late Reactions	1 Participants
Number of Participants With Late or Persistent Positive Patch Test Reactions MDBGN · Neither	110 Participants
Number of Participants With Late or Persistent Positive Patch Test Reactions Gold · Persistent Reactions	15 Participants
Number of Participants With Late or Persistent Positive Patch Test Reactions Gold · Late Reactions	15 Participants
Number of Participants With Late or Persistent Positive Patch Test Reactions Gold · Neither	81 Participants
Number of Participants With Late or Persistent Positive Patch Test Reactions Hydrocortisone · Persistent Reactions	0 Participants
Number of Participants With Late or Persistent Positive Patch Test Reactions Hydrocortisone · Late Reactions	2 Participants
Number of Participants With Late or Persistent Positive Patch Test Reactions Hydrocortisone · Neither	109 Participants
Number of Participants With Late or Persistent Positive Patch Test Reactions Bacitracin · Persistent Reactions	9 Participants
Number of Participants With Late or Persistent Positive Patch Test Reactions Bacitracin · Late Reactions	7 Participants
Number of Participants With Late or Persistent Positive Patch Test Reactions Bacitracin · Neither	95 Participants
Number of Participants With Late or Persistent Positive Patch Test Reactions Parthenolide · Persistent Reactions	1 Participants
Number of Participants With Late or Persistent Positive Patch Test Reactions Parthenolide · Late Reactions	6 Participants
Number of Participants With Late or Persistent Positive Patch Test Reactions Parthenolide · Neither	104 Participants
Number of Participants With Late or Persistent Positive Patch Test Reactions Disperse Blue · Persistent Reactions	2 Participants
Number of Participants With Late or Persistent Positive Patch Test Reactions Disperse Blue · Late Reactions	2 Participants
Number of Participants With Late or Persistent Positive Patch Test Reactions Disperse Blue · Neither	107 Participants
Number of Participants With Late or Persistent Positive Patch Test Reactions Bronopol · Persistent Reactions	6 Participants
Number of Participants With Late or Persistent Positive Patch Test Reactions Bronopol · Late Reactions	13 Participants
Number of Participants With Late or Persistent Positive Patch Test Reactions Bronopol · Neither	92 Participants

Adverse Events

Evaluation of T.R.U.E. Test Experimental Allergens

Serious events: 1 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Evaluation of T.R.U.E. Test Experimental Allergens n=116 participants at risk Adverse events were captured for subjects patched with TRUE Test Panels 1.3, 2,2 and 3.2. Panel 1 allergens nickel sulfate (0.60 mg/cm2), potassium dichromate (0.054 mg/cm2), fragrance mix (0.050 mg/cm2) and ethylenediamine dihydrochloride (0.050 mg/cm2), Panel 2 allergen Methyldibromoglutaronitrile (0.0053 mg/cm2) and Panel 3 allergens Gold sodium thiosulfate (0.075 mg/cm2), Hydrocortisone-17-butyrate (0.020 mg/cm2), Bacitracin (0.60 mg/cm2), Parthenolide (0.0030 mg/cm2), Disperse blue 106 (0.050 mg/cm2 in PVP), 2-Bromo-2-nitropropane-1,3-diol (Bronopol) (0.25 mg/cm2) will be evaluated
Infections and infestations Appendicitis	0.86% 1/116 • Number of events 1 • Days 2-21 Adverse events cannot be attributed to a single allergen as the allergen panels contained all allergens.

Other adverse events

Other adverse events
Measure	Evaluation of T.R.U.E. Test Experimental Allergens n=116 participants at risk Adverse events were captured for subjects patched with TRUE Test Panels 1.3, 2,2 and 3.2. Panel 1 allergens nickel sulfate (0.60 mg/cm2), potassium dichromate (0.054 mg/cm2), fragrance mix (0.050 mg/cm2) and ethylenediamine dihydrochloride (0.050 mg/cm2), Panel 2 allergen Methyldibromoglutaronitrile (0.0053 mg/cm2) and Panel 3 allergens Gold sodium thiosulfate (0.075 mg/cm2), Hydrocortisone-17-butyrate (0.020 mg/cm2), Bacitracin (0.60 mg/cm2), Parthenolide (0.0030 mg/cm2), Disperse blue 106 (0.050 mg/cm2 in PVP), 2-Bromo-2-nitropropane-1,3-diol (Bronopol) (0.25 mg/cm2) will be evaluated
General disorders Chest pain	0.86% 1/116 • Number of events 1 • Days 2-21 Adverse events cannot be attributed to a single allergen as the allergen panels contained all allergens.
Respiratory, thoracic and mediastinal disorders Cough	1.7% 2/116 • Number of events 2 • Days 2-21 Adverse events cannot be attributed to a single allergen as the allergen panels contained all allergens.
Skin and subcutaneous tissue disorders Dermatitis	1.7% 2/116 • Number of events 2 • Days 2-21 Adverse events cannot be attributed to a single allergen as the allergen panels contained all allergens.
General disorders Discomfort	0.86% 1/116 • Number of events 1 • Days 2-21 Adverse events cannot be attributed to a single allergen as the allergen panels contained all allergens.
Nervous system disorders Dizziness	0.86% 1/116 • Number of events 1 • Days 2-21 Adverse events cannot be attributed to a single allergen as the allergen panels contained all allergens.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.86% 1/116 • Number of events 1 • Days 2-21 Adverse events cannot be attributed to a single allergen as the allergen panels contained all allergens.
Ear and labyrinth disorders Ear pain	0.86% 1/116 • Number of events 1 • Days 2-21 Adverse events cannot be attributed to a single allergen as the allergen panels contained all allergens.
Skin and subcutaneous tissue disorders Eczema	0.86% 1/116 • Number of events 1 • Days 2-21 Adverse events cannot be attributed to a single allergen as the allergen panels contained all allergens.
Eye disorders Eye irritation	0.86% 1/116 • Number of events 1 • Days 2-21 Adverse events cannot be attributed to a single allergen as the allergen panels contained all allergens.
Immune system disorders Food allergy	0.86% 1/116 • Number of events 1 • Days 2-21 Adverse events cannot be attributed to a single allergen as the allergen panels contained all allergens.
Nervous system disorders Headache	0.86% 1/116 • Number of events 1 • Days 2-21 Adverse events cannot be attributed to a single allergen as the allergen panels contained all allergens.
Vascular disorders Hot flush	0.86% 1/116 • Number of events 1 • Days 2-21 Adverse events cannot be attributed to a single allergen as the allergen panels contained all allergens.
Injury, poisoning and procedural complications Limb injury	0.86% 1/116 • Number of events 1 • Days 2-21 Adverse events cannot be attributed to a single allergen as the allergen panels contained all allergens.
Infections and infestations Nasopharyngitis	5.2% 6/116 • Number of events 6 • Days 2-21 Adverse events cannot be attributed to a single allergen as the allergen panels contained all allergens.
General disorders Pain	0.86% 1/116 • Number of events 1 • Days 2-21 Adverse events cannot be attributed to a single allergen as the allergen panels contained all allergens.
Infections and infestations Pharyngitis streptococcal	0.86% 1/116 • Number of events 1 • Days 2-21 Adverse events cannot be attributed to a single allergen as the allergen panels contained all allergens.
Nervous system disorders Presyncope	0.86% 1/116 • Number of events 1 • Days 2-21 Adverse events cannot be attributed to a single allergen as the allergen panels contained all allergens.
Skin and subcutaneous tissue disorders Pruritus	7.8% 9/116 • Number of events 9 • Days 2-21 Adverse events cannot be attributed to a single allergen as the allergen panels contained all allergens.
Infections and infestations Pyoderma	0.86% 1/116 • Number of events 1 • Days 2-21 Adverse events cannot be attributed to a single allergen as the allergen panels contained all allergens.
Skin and subcutaneous tissue disorders Rash	3.4% 4/116 • Number of events 4 • Days 2-21 Adverse events cannot be attributed to a single allergen as the allergen panels contained all allergens.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.86% 1/116 • Number of events 1 • Days 2-21 Adverse events cannot be attributed to a single allergen as the allergen panels contained all allergens.
Skin and subcutaneous tissue disorders Skin depigmentation	0.86% 1/116 • Number of events 1 • Days 2-21 Adverse events cannot be attributed to a single allergen as the allergen panels contained all allergens.
Skin and subcutaneous tissue disorders Skin infection	0.86% 1/116 • Number of events 1 • Days 2-21 Adverse events cannot be attributed to a single allergen as the allergen panels contained all allergens.
Skin and subcutaneous tissue disorders Skin reaction	0.86% 1/116 • Number of events 1 • Days 2-21 Adverse events cannot be attributed to a single allergen as the allergen panels contained all allergens.
Infections and infestations Staphylococcal infection	1.7% 2/116 • Number of events 2 • Days 2-21 Adverse events cannot be attributed to a single allergen as the allergen panels contained all allergens.
Infections and infestations Urinary tract infection	0.86% 1/116 • Number of events 1 • Days 2-21 Adverse events cannot be attributed to a single allergen as the allergen panels contained all allergens.
Skin and subcutaneous tissue disorders Urticaria	0.86% 1/116 • Number of events 1 • Days 2-21 Adverse events cannot be attributed to a single allergen as the allergen panels contained all allergens.
Gastrointestinal disorders Vomiting	0.86% 1/116 • Number of events 1 • Days 2-21 Adverse events cannot be attributed to a single allergen as the allergen panels contained all allergens.

Additional Information

Kathryn Shannon

Allerderm(dba) SmartPractice

Phone: 602 225 0595

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place