Allergic Contact Dermatitis
Conditions
Keywords
Contact dermatitis, Eczema
Brief summary
The objective of the study was to evaluate the diagnostic performance and safety of T.R.U.E. Test allergens in pediatric subjects aged 6-17 years old. In total, 11 allergens were evaluated; 7 new allergens on panels 2.2 and 3.2 and 4 previously approved allergens for which changes were made to dose and excipient.
Detailed description
The evaluation of 7 new allergens on panels 2.2 and 3.2, Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol was the original objective of the study. The protocol was amended to include evaluation of 4 reformulated allergens; neomycin sulfate, potassium dichromate, ethylenediamne dihydrochloride and fragrance mix.
Interventions
DIAGNOSTIC_TESTPanels 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.
Sponsors
Allerderm
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
3 T.R.U.E. Test panels were applied to the paraspinal regional of the back and were to be worn for approximately 48 hours. Post application evaluations were performed at days 3, 4, 7(+1) and 21(+2).
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Symptoms and history potentially consistent with allergic contact dermatitis * Children and adolescents 6-17 years of age, in general good health * Adolescent females 15 years of age or older (or with menarche) must consent to a urine pregnancy test; urine test results must be negative for study inclusion * Informed consent must be signed and understood by subject. If underage, informed consent must be signed and understood by parent or legal guardian, consistent with all institutional, local and national regulations
Exclusion criteria
* Topical corticosteroid treatment during the last 7 days on or near the test area. * Systemic treatment with corticosteroids or other immunosuppressives during the last 7 days. * Subjects currently receiving (or received during the previous 3 weeks) other investigational drugs, treatments or devices, or participating in another clinical study * Treatment with ultraviolet (UV) light (including tanning) during the previous 3 weeks * Acute dermatitis outbreak or dermatitis on or near the test area on the back * Subjects unable to comply with activity restrictions (e.g. protecting test panels from excess moisture due to showering or vigorous activity) * Subjects unable or unwilling to comply with multiple return visits * Female subjects 15 years of age (or with onset of menarche) and older unable to consent to a urine pregnancy test, or those with a positive pregnancy test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Investigator Determination of Positive Reaction: 21 days post application | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Late or Persistent Positive Patch Test Reactions | Day 7-21 | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Positive Response Rates: 7 New and 4 Reformulated Allergens 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. | 116 |
| Total | 116 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 5 |
Baseline characteristics
| Characteristic | Positive Response Rates: 7 New and 4 Reformulated Allergens |
|---|---|
| Age, Continuous | 12.6 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 44 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 72 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 13 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 78 Participants |
| Region of Enrollment United States | 116 participants |
| Sex: Female, Male Female | 80 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 47 / 116 |
| serious Total, serious adverse events | 1 / 116 |
Outcome results
Primary
Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores
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
Time frame: Investigator Determination of Positive Reaction: 21 days post application
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Neomycin sulfate | Negative | 49 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Neomycin sulfate | Positive | 3 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Neomycin sulfate | Irritant | 0 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Neomycin sulfate | Doubtful | 1 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Neomycin sulfate | Not Tested with this Allergen | 58 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Potassium dichromate | Negative | 50 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Potassium dichromate | Positive | 2 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Potassium dichromate | Irritant | 0 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Potassium dichromate | Doubtful | 1 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Potassium dichromate | Not Tested with this Allergen | 58 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Fragrance Mix | Negative | 48 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Fragrance Mix | Positive | 2 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Fragrance Mix | Irritant | 0 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Fragrance Mix | Doubtful | 3 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Fragrance Mix | Not Tested with this Allergen | 58 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Ethylenediamine | Negative | 53 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Ethylenediamine | Positive | 0 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Ethylenediamine | Irritant | 0 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Ethylenediamine | Doubtful | 0 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Ethylenediamine | Not Tested with this Allergen | 58 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | MDBGN | Positive | 1 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | MDBGN | Irritant | 0 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | MDBGN | Doubtful | 3 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | MDBGN | Not Tested with this Allergen | 0 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Gold | Negative | 69 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Gold | Positive | 31 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Gold | Irritant | 0 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Gold | Doubtful | 11 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Gold | Not Tested with this Allergen | 0 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Hydrocortisone | Positive | 2 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Hydrocortisone | Doubtful | 3 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Hydrocortisone | Not Tested with this Allergen | 0 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Bacitracin | Negative | 90 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Bacitracin | Doubtful | 5 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Bacitracin | Not Tested with this Allergen | 0 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Parthenolide | Negative | 97 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Parthenolide | Positive | 7 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Parthenolide | Irritant | 0 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Parthenolide | Doubtful | 7 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Parthenolide | Not Tested with this Allergen | 0 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Disperse Blue | Negative | 102 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Disperse Blue | Positive | 4 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Disperse Blue | Not Tested with this Allergen | 0 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Bronopol | Negative | 89 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Bronopol | Positive | 19 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Bronopol | Irritant | 0 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Bronopol | Doubtful | 3 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Bronopol | Not Tested with this Allergen | 0 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | MDBGN | Negative | 107 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Hydrocortisone | Negative | 106 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Hydrocortisone | Irritant | 0 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Bacitracin | Positive | 16 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Bacitracin | Irritant | 0 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Disperse Blue | Irritant | 0 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores | Disperse Blue | Doubtful | 5 Participants |
Secondary
Number of Participants With Late or Persistent Positive Patch Test Reactions
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.
Time frame: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | Neomycin sulfate | Persistent Reactions | 2 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | Neomycin sulfate | Late Reactions | 1 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | Neomycin sulfate | Neither | 108 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | Potassium dichromate | Persistent Reactions | 0 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | Potassium dichromate | Late Reactions | 1 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | Potassium dichromate | Neither | 110 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | Fragrance mix | Persistent Reactions | 2 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | Fragrance mix | Late Reactions | 0 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | Fragrance mix | Neither | 109 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | Ethylenediamine | Persistent Reactions | 0 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | Ethylenediamine | Late Reactions | 0 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | Ethylenediamine | Neither | 111 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | MDBGN | Persistent Reactions | 0 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | MDBGN | Late Reactions | 1 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | MDBGN | Neither | 110 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | Gold | Persistent Reactions | 15 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | Gold | Late Reactions | 15 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | Gold | Neither | 81 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | Hydrocortisone | Persistent Reactions | 0 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | Hydrocortisone | Late Reactions | 2 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | Hydrocortisone | Neither | 109 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | Bacitracin | Persistent Reactions | 9 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | Bacitracin | Late Reactions | 7 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | Bacitracin | Neither | 95 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | Parthenolide | Persistent Reactions | 1 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | Parthenolide | Late Reactions | 6 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | Parthenolide | Neither | 104 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | Disperse Blue | Persistent Reactions | 2 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | Disperse Blue | Late Reactions | 2 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | Bronopol | Persistent Reactions | 6 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | Bronopol | Neither | 92 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | Disperse Blue | Neither | 107 Participants |
| Positive Response Rates: 7 New and 4 Reformulated Allergens | Number of Participants With Late or Persistent Positive Patch Test Reactions | Bronopol | Late Reactions | 13 Participants |