Contact Dermatitis
Conditions
Keywords
Dermatitis, Contact, Bronopol, Disperse Blue 106
Brief summary
We propose a prospective, multi-center, double-blind, randomized study comparing the diagnostic performance (primary) and safety (secondary) of 3 concentrations of Disperse blue 106 and 4 concentrations of Bronopol in 40 adult subjects (20 subjects per allergen) with a clinical history of contact dermatitis and a positive patch test (current or previous) to the corresponding reference petrolatum allergen (sensitives).
Detailed description
Primary endpoint: To evaluate the diagnostic performance of Disperse blue 106 and Bronopol T.R.U.E. Test allergens in 20 adult subjects per allergen with a clinical history of contact dermatitis and a positive patch test to the respective reference allergen. Evaluations will include: * Determination of the lowest concentration eliciting positive skin reactions (+1 or +2) in 70-90% of sensitive subjects. * Frequency of positive, negative, doubtful and irritant reactions for each allergen and tested concentration. * Concordance/discordance as compared to the corresponding reference petrolatum allergen. Secondary endpoint: To evaluate the safety of Disperse blue 106 and Bronopol T.R.U.E. Test allergens in 20 adult subjects per allergen with a clinical history of contact dermatitis and a positive patch test to the respective reference allergen. Evaluations will include: * The frequency of tape-induced irritation at the test site, incomplete panel adhesion, and subject-reported sensations of itching or burning. * The frequency and characterization of adverse events and serious adverse events. * The frequency and characterization of late and/or persistent reactions.
Interventions
Disperse blue 106 in PVP, 0.15 mg/cm2 Disperse blue 106 in PVP, 0.050 mg/cm2 Disperse blue 106 in PVP, 0.017 mg/cm2 PVP Negative Control Bronopol in PVP, 0.75 mg/cm2 Bronopol in PVP, 0.50 mg/cm2 Bronopol in PVP, 0.25 mg/cm2 Bronopol in PVP, 0.125 mg/cm2 Test patches, with allergens, are placed at day one and removed 48 hours later. The duration of the study lasts 21 days. However, the subject is only exposed to the study allergens for 48 hours.
Sponsors
Allerderm
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Current or previous symptoms and/or history consistent with allergic contact dermatitis, and positive patch test (within the past 5 years) to Bronopol OR Current or previous symptoms and/or history consistent with allergic contact dermatitis, and a positive patch test (within the past 5 years) to Disperse blue 106 or Disperse blue 106/124 allergen mix. * All subjects must be adults (18 years of age or older) and otherwise in good health. * Premenopausal female subjects must consent to a urine pregnancy test; results must be negative for study inclusion. * Informed consent must be signed and understood by each subject, and consistent with all institutional, local and national regulations.
Exclusion criteria
* Subjects unable to meet inclusion requirements. * Women who are breastfeeding or pregnant. * Topical treatment during the last 7 days with corticosteroids or other immunosuppressive agents on or near the test area. * Systemic treatment during the last 7 days with corticosteroids (equivalent to \> 10 mg prednisone) or other immunosuppressive agents. * 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 patch test study requirements including multiple return visits and activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity). * Subject participation in clinical trials of investigational drugs, treatments or devices other than T.R.U.E. Test during this study or 3 weeks prior to inclusion in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Performance: Optimal Test Allergen Concentration | Visits 3-5: 3-21 days after application | Lowest concentration eliciting 1+ or 2+ positive reactions in 70-90% of subjects |
| Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | Visit 3: 3 days after application | Percentage (including confidence intervals) of subjects who elicited positive, negative, doubtful and irritant reactions to disperse blue at visit 3- all subjects |
| Concordance Between Investigational Allergen and Reference Allergen | Visit 5: 21 days after patch application | Concordance between disperse blue or bronopol and the respective reference petrolatum allergen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning | Day 2-21 | Percentage of subjects who exhibited irritation and itching or burning at patch removal (entire panel is evaluated) and late/persistent reactions. Late reactions occur 7-10 days after patch application Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application |
| Adverse Events | Days 0-21 | The adverse event-reporting period began at application and ended with the Day 21 visit. Adverse events were followed until they resolved. Serious adverse events and those assessed by the investigator as possibly related to the investigational product were to be followed until they resolved or until the investigator assessed them as chronic or stable. |
Countries
Denmark, United States
Participant flow
Recruitment details
Dates of recruitment: 16 June 2008 through 7 April 2009. This study was conducted at two investigational sites located in Denmark (E Paulsen) and the United States (J Fowler).
Pre-assignment details
There were no significant events or approaches which caused enrolled participants to be excluded from the trial before assignment to a group.
Participants by arm
| Arm | Count |
|---|---|
| Sensitives Subjects with a clinical history and positive patch test (current or previous) to either Disperse Blue 106 or Bronopol. Subjects must otherwise be healthy and fulfill entry criteria. | 48 |
| Total | 48 |
Baseline characteristics
| Characteristic | Sensitives |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants |
| Age, Continuous | 52.2 years STANDARD_DEVIATION 14.7 |
| Region of Enrollment Denmark | 21 participants |
| Region of Enrollment United States | 27 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 48 |
| serious Total, serious adverse events | 0 / 48 |
Outcome results
Primary
Concordance Between Investigational Allergen and Reference Allergen
Concordance between disperse blue or bronopol and the respective reference petrolatum allergen
Time frame: Visit 5: 21 days after patch application
Population: Data from one subject not included because subject did not have past positive response to either allergen.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Disperse Blue 0.017 mg/cm2 | Concordance Between Investigational Allergen and Reference Allergen | 81.0 percentage of agreement |
| Disperse Blue 0.050 mg/cm2 | Concordance Between Investigational Allergen and Reference Allergen | 95.2 percentage of agreement |
| Disperse Blue 0.150 mg/cm2 | Concordance Between Investigational Allergen and Reference Allergen | 90.5 percentage of agreement |
| Bronopol 0.125 mg/cm2 | Concordance Between Investigational Allergen and Reference Allergen | 84.6 percentage of agreement |
| Bronopol 0.250 mg/cm2 | Concordance Between Investigational Allergen and Reference Allergen | 100.0 percentage of agreement |
| Bronopol 0.500 mg/cm2 | Concordance Between Investigational Allergen and Reference Allergen | 76.9 percentage of agreement |
| Bronopol 0.750 mg/cm2 | Concordance Between Investigational Allergen and Reference Allergen | 61.5 percentage of agreement |
Primary
Diagnostic Performance: Optimal Test Allergen Concentration
Lowest concentration eliciting 1+ or 2+ positive reactions in 70-90% of subjects
Time frame: Visits 3-5: 3-21 days after application
Population: Percentage is based on subjects sensitive to each allergen. Results from one subject not included due to no past history of positive patch test.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Disperse Blue 0.017 mg/cm2 | Diagnostic Performance: Optimal Test Allergen Concentration | 38.1 percentage of participants |
| Disperse Blue 0.050 mg/cm2 | Diagnostic Performance: Optimal Test Allergen Concentration | 47.6 percentage of participants |
| Disperse Blue 0.150 mg/cm2 | Diagnostic Performance: Optimal Test Allergen Concentration | 52.4 percentage of participants |
| Bronopol 0.125 mg/cm2 | Diagnostic Performance: Optimal Test Allergen Concentration | 30.8 percentage of participants |
| Bronopol 0.250 mg/cm2 | Diagnostic Performance: Optimal Test Allergen Concentration | 23.1 percentage of participants |
| Bronopol 0.500 mg/cm2 | Diagnostic Performance: Optimal Test Allergen Concentration | 46.2 percentage of participants |
| Bronopol 0.750 mg/cm2 | Diagnostic Performance: Optimal Test Allergen Concentration | 61.5 percentage of participants |
Primary
Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration
Percent (including confidence intervals) of subjects who elicited positive, negative, doubtful and irritant reactions to disperse blue at visit 4- all subjects
Time frame: Visit 4: 7 days after application
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Disperse Blue 0.017 mg/cm2 | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 18.8 percentage of participants |
| Disperse Blue 0.050 mg/cm2 | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 18.8 percentage of participants |
| Disperse Blue 0.150 mg/cm2 | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 27.1 percentage of participants |
| Bronopol 0.125 mg/cm2 | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 0.0 percentage of participants |
| Bronopol 0.250 mg/cm2 | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 75.0 percentage of participants |
| Bronopol 0.500 mg/cm2 | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 72.9 percentage of participants |
| Bronopol 0.750 mg/cm2 | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 70.8 percentage of participants |
| Negative Control Negative Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 97.9 percentage of participants |
| Disperse Blue 0.017 mg/cm2 Irritant Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 0.0 percentage of participants |
| Disperse Blue 0.050 mg/cm2 Irritant Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 0.0 percentage of participants |
| Disperse Blue 0.150 mg/cm2 Irritant Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 0.0 percentage of participants |
| Negative Control Irritant Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 0.0 percentage of participants |
| Disperse Blue 0.017 mg/cm2 Doubtful Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 6.3 percentage of participants |
| Disperse Blue 0.050 mg/cm2 Doubtful Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 8.3 percentage of participants |
| Disperse Blue 0.150 mg/cm2 Doubtful Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 2.1 percentage of participants |
| Negative Control Doubtful Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 2.1 percentage of participants |
Primary
Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration
Percentage (including confidence intervals) of subjects who exhibited positive, negative, doubtful and irritant reactions to bronopol at visit 3- all subjects
Time frame: Visit 3: 3 days after application
Population: Data from one subject not included because subject did not have a past positive response to either allergen.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Disperse Blue 0.017 mg/cm2 | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 14.6 percentage of participants |
| Disperse Blue 0.050 mg/cm2 | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 14.6 percentage of participants |
| Disperse Blue 0.150 mg/cm2 | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 25.0 percentage of participants |
| Bronopol 0.125 mg/cm2 | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 45.8 percentage of participants |
| Bronopol 0.250 mg/cm2 | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 79.2 percentage of participants |
| Bronopol 0.500 mg/cm2 | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 72.9 percentage of participants |
| Bronopol 0.750 mg/cm2 | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 58.3 percentage of participants |
| Negative Control Negative Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 37.5 percentage of participants |
| Disperse Blue 0.017 mg/cm2 Irritant Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 0.0 percentage of participants |
| Disperse Blue 0.050 mg/cm2 Irritant Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 0.0 percentage of participants |
| Disperse Blue 0.150 mg/cm2 Irritant Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 2.1 percentage of participants |
| Negative Control Irritant Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 0.0 percentage of participants |
| Disperse Blue 0.017 mg/cm2 Doubtful Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 6.3 percentage of participants |
| Disperse Blue 0.050 mg/cm2 Doubtful Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 12.5 percentage of participants |
| Disperse Blue 0.150 mg/cm2 Doubtful Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 14.6 percentage of participants |
| Negative Control Doubtful Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 16.7 percentage of participants |
Primary
Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration
Percentage (including confidence intervals) of subjects who exhibited positive, negative, doubtful and irritant reactions to bronopol at visit 4- all subjects
Time frame: Visit 4: 7 days after application
Population: Data from one subject not included because subject did not have past positive response to either allergen.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Disperse Blue 0.017 mg/cm2 | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 14.9 percentage of participants |
| Disperse Blue 0.050 mg/cm2 | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 17.0 percentage of participants |
| Disperse Blue 0.150 mg/cm2 | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 21.3 percentage of participants |
| Bronopol 0.125 mg/cm2 | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 29.8 percentage of participants |
| Bronopol 0.250 mg/cm2 | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 78.7 percentage of participants |
| Bronopol 0.500 mg/cm2 | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 74.5 percentage of participants |
| Bronopol 0.750 mg/cm2 | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 59.6 percentage of participants |
| Negative Control Negative Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 57.4 percentage of participants |
| Disperse Blue 0.017 mg/cm2 Irritant Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 0.0 percentage of participants |
| Disperse Blue 0.050 mg/cm2 Irritant Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 0.0 percentage of participants |
| Disperse Blue 0.150 mg/cm2 Irritant Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 4.3 percentage of participants |
| Negative Control Irritant Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 8.5 percentage of participants |
| Disperse Blue 0.017 mg/cm2 Doubtful Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 6.4 percentage of participants |
| Disperse Blue 0.050 mg/cm2 Doubtful Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 8.5 percentage of participants |
| Disperse Blue 0.150 mg/cm2 Doubtful Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 14.9 percentage of participants |
| Negative Control Doubtful Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 4.3 percentage of participants |
Primary
Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration
Percentage (including confidence intervals) of subjects who elicited positive, negative, doubtful and irritant reactions to disperse blue at visit 3- all subjects
Time frame: Visit 3: 3 days after application
Population: All subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Disperse Blue 0.017 mg/cm2 | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 16.7 percentage of participants |
| Disperse Blue 0.050 mg/cm2 | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 18.8 percentage of participants |
| Disperse Blue 0.150 mg/cm2 | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 25.0 percentage of participants |
| Bronopol 0.125 mg/cm2 | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 2.1 percentage of participants |
| Bronopol 0.250 mg/cm2 | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 75.0 percentage of participants |
| Bronopol 0.500 mg/cm2 | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 77.1 percentage of participants |
| Bronopol 0.750 mg/cm2 | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 72.9 percentage of participants |
| Negative Control Negative Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 91.7 percentage of participants |
| Disperse Blue 0.017 mg/cm2 Irritant Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 0.0 percentage of participants |
| Disperse Blue 0.050 mg/cm2 Irritant Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 0.0 percentage of participants |
| Disperse Blue 0.150 mg/cm2 Irritant Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 0.0 percentage of participants |
| Negative Control Irritant Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 0.0 percentage of participants |
| Disperse Blue 0.017 mg/cm2 Doubtful Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 8.3 percentage of participants |
| Disperse Blue 0.050 mg/cm2 Doubtful Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 4.2 percentage of participants |
| Disperse Blue 0.150 mg/cm2 Doubtful Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 2.1 percentage of participants |
| Negative Control Doubtful Reactions | Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration | 6.3 percentage of participants |
Secondary
Adverse Events
The adverse event-reporting period began at application and ended with the Day 21 visit. Adverse events were followed until they resolved. Serious adverse events and those assessed by the investigator as possibly related to the investigational product were to be followed until they resolved or until the investigator assessed them as chronic or stable.
Time frame: Days 0-21
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Disperse Blue 0.017 mg/cm2 | Adverse Events | 1 events |
| Disperse Blue 0.050 mg/cm2 | Adverse Events | 1 events |
Secondary
Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning
Percentage of subjects who exhibited irritation and itching or burning at patch removal (entire panel is evaluated) and late/persistent reactions. Late reactions occur 7-10 days after patch application Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application
Time frame: Day 2-21
Population: Data from one subject not included because subject did not have past positive response to either allergen.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Disperse Blue 0.017 mg/cm2 | Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning | 71.4 percentage of participants |
| Disperse Blue 0.050 mg/cm2 | Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning | 65.4 percentage of participants |
| Disperse Blue 0.150 mg/cm2 | Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning | 76.2 percentage of participants |
| Bronopol 0.125 mg/cm2 | Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning | 73.1 percentage of participants |
| Bronopol 0.250 mg/cm2 | Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning | 0 percentage of participants |
| Bronopol 0.500 mg/cm2 | Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning | 0 percentage of participants |
| Bronopol 0.750 mg/cm2 | Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning | 0 percentage of participants |
| Negative Control Negative Reactions | Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning | 0 percentage of participants |
| Disperse Blue 0.017 mg/cm2 Irritant Reactions | Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning | 19.0 percentage of participants |
| Disperse Blue 0.050 mg/cm2 Irritant Reactions | Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning | 19.0 percentage of participants |
| Disperse Blue 0.150 mg/cm2 Irritant Reactions | Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning | 28.6 percentage of participants |
| Negative Control Irritant Reactions | Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning | 1.9 percentage of participants |
| Disperse Blue 0.017 mg/cm2 Doubtful Reactions | Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning | 0 percentage of participants |
| Disperse Blue 0.050 mg/cm2 Doubtful Reactions | Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning | 0 percentage of participants |
| Disperse Blue 0.150 mg/cm2 Doubtful Reactions | Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning | 0 percentage of participants |
| Negative Control Doubtful Reactions | Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning | 0 percentage of participants |
| Bronopol 0.125 mg/cm2 Persistent Reactions | Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning | 11.5 percentage of participants |
| Bronopol 0.250 mg/cm2 Persistent Reactions | Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning | 15.4 percentage of participants |
| Bronopol 0.500 mg/cm2 Persistent Reactions | Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning | 11.5 percentage of participants |
| Bronopol 0.750 mg/cm2 Persistent Reactions | Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning | 11.5 percentage of participants |