Dermatitis, Eczematous
Conditions
Brief summary
48-hour application of metal allergen patches to test for potential allergic responses.
Detailed description
A 48-hour application (approximate) of investigational allergen panels, excipient controls and corresponding reference allergens will be applied to the skin of human subjects to test for potential positive allergic responses. Test sites will be evaluated at 3-4, 7-8, 10-14 and 19-23 days after application. Ascending allergen dosages will be randomized within each panel into three different configurations which will be randomly assigned to subjects as they enter the study. The investigators and subjects will be aware of the allergens and the patch test doses but will not be aware of the location of individual allergens within each panel.
Interventions
BIOLOGICALMetal Allergen Epicutaneous Patch
48 hour application of metal allergen patch to diagnose contact dermatitis
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
1. 18 years of age or older. 2. Past positive patch test result within the past 10 years (to one of the dilution series metals being tested on this study) or strong suspicion of metal contact allergy based on results of the Qualification Questionnaire. 3. Unable to become pregnant or willing to use an acceptable method of contraception to prevent pregnancy if female of childbearing potential; (Inability to become pregnant includes all male subjects and female subjects who are postmenopausal for at least 1 year, or surgically sterile- have had a hysterectomy, bilateral ovariectomy, uterine ablation or bilateral tubal ligation. Acceptable methods of contraception include: 1) systemic birth control; 2) double barrier method; 3) intrauterine device; 4) vasectomized partner; or 5) abstinence from sexual intercourse. Subject must agree to use acceptable contraception for the duration of the entire study.) 4. Understands and signs the approved Informed Consent form which is consistent with all institutional, local and national regulations.
Exclusion criteria
1. Breastfeeding or pregnant (as determined by urine pregnancy test) or intending to become pregnant during the course of the study. 2. Topical treatment with corticosteroids or other immunosuppressive agents on or near the test area during the 14 days prior to inclusion in this study. 3. Systemic treatment with corticosteroids (equivalent to \> 10 mg prednisone) or other immunosuppressive agents during the 14 days prior to inclusion in this study. Inhaled treatments are permitted. NOTE: Steroidal nose or eye drops are permitted. 4. Treatment with ultraviolet (UV) light (including tanning) during the 3 weeks prior to inclusion in this study. 5. Acute dermatitis outbreak or dermatitis on or near the test area on the back. 6. Conditions such as; fibromyalgia, chronic fatigue, depression, cognitive impairment, flu-like symptoms, diarrhea and/or headache without at least one of the symptoms related to metal exposure listed in Section 10.1 under physical examination 7. Inability 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). 8. Participation in a clinical trial of an investigational drug, treatment or device during this study or 3 weeks prior to inclusion in this study. 9. An opinion of the Investigator that deems the potential subject to be non-compliant, unable to return for study visits or complete the study as detailed in the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Patch Test Responses | 21 days post patch application | Allergen patch test sites were scored at Visit 3 (day 3-4) Visit 4 (day 7-8) Visit 5 (day 10-14) and Visit 6 Day 19-23). Determination of positive or negative test response for each allergen dose was assessed by the investigator following the final visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Panel Adhesion | Day 2, visit 2 prior to panel removal | Panel Adhesion was measured at Visit 2 (day 2) prior to panel removal according to the following scale: Excellent- Skin contact good; all tape edges adherent; all allergens in contact with the skin, Good- Skin contact acceptable; some tape edges lifting; all allergens in contact with the skin, Poor- Little to no skin contact with panel; one or more allergens not in contact with the skin, Detached- Panel completely off the skin; none of the allergens in contact with the skin |
| Tape Irritation | Visit 2 (day 2), visit 3 (day 3-4), visit 4 (day 7-8) visit 5 (day 10-14), visit 6 (day 19-23) with overall assessment by the Investigator following visit 6 | Tape irritation was measured according to the following scale: None- No irritation, Weak- Faint to definite pink erythema, Moderate- Moderate erythema, definite redness, Strong- Severe erythema, very intense redness. Following visit 6, the Investigators rated tape irritation based on the overall trend observed at visits 2-6. Irritation at visit 2 that resolved by visit 3 was considered none. Skin under occlusion from an adhesive material would be expected to have minimal irritation shortly after the panel is removed. Irritation that persisted or increased in severity beyond visit 3 but resolved by the following visit would have been rated as irritant. An allergic response was considered if irritation persisted beyond visit 3, increased in severity and had symptoms consistent with criteria used to score positive skin reactions according to standard patch testing guidelines established by the International Contact Dermatitis Research Group. |
| Chip Irritation | Visit 2 (day 2), visit 3 (day 3-4), visit 4 (day 7-8) visit 5 (day 10-14), visit 6 (day 19-23) with overall assessment by the Investigator following visit 6 | Chip irritation was measured according to the following scale: None- No irritation, Weak- Faint to definite pink erythema, Moderate- Moderate erythema, definite redness, Strong- Severe erythema, very intense redness. Following visit 6, the Investigators rated Chip irritation based on the overall trend observed at visits 2-6. Irritation at visit 2 that resolved by visit 3 was considered none. Skin under occlusion from an adhesive material would be expected to have minimal irritation shortly after the panel is removed. Irritation that persisted or increased in severity beyond visit 3 but resolved by the following visit would have been rated as irritant. An allergic response was considered if irritation persisted beyond visit 3, increased in severity and had symptoms consistent with criteria used to score positive skin reactions according to standard patch testing guidelines established by the International Contact Dermatitis Research Group. |
Countries
Germany, Italy, Japan, Netherlands, Switzerland, United States
Participant flow
Recruitment details
The study population will consist of subjects with past positive patch test result to at least one of the dilution series metals being tested on this study or strong suspicion of metal contact allergy.
Pre-assignment details
Subjects with a past positive patch test will be tested with the allergen panel and corresponding reference allergen(s) to which they had the previous response. Subjects with suspicion of metal contact allergy will be tested with all dilution series and reference allergens. Not all subjects tested all allergens
Participants by arm
| Arm | Count |
|---|---|
| All Subjects All enrolled subjects were patch tested with ascending doses of investigational allergens on panes 1-5. At least 15 subjects with positive patch test responses (score of 1+, 2+ or 3+) were needed to determine optimal dose. | 122 |
| Total | 122 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 60.0 years |
| Race/Ethnicity, Customized Asian | 44 Participants |
| Race/Ethnicity, Customized European | 64 Participants |
| Race/Ethnicity, Customized Latin/South American/Caribbean | 1 Participants |
| Race/Ethnicity, Customized North American | 13 Participants |
| Region of Enrollment Germany | 30 participants |
| Region of Enrollment Italy | 9 participants |
| Region of Enrollment Japan | 44 participants |
| Region of Enrollment Netherlands | 20 participants |
| Region of Enrollment Switzerland | 6 participants |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 93 Participants |
| Sex: Female, Male Male | 29 Participants |
| Subjects with past allergic response or suspicion of allergy | 122 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 122 |
| other Total, other adverse events | 30 / 122 |
| serious Total, serious adverse events | 1 / 122 |
Outcome results
Primary
Number of Participants With Patch Test Responses
Allergen patch test sites were scored at Visit 3 (day 3-4) Visit 4 (day 7-8) Visit 5 (day 10-14) and Visit 6 Day 19-23). Determination of positive or negative test response for each allergen dose was assessed by the investigator following the final visit.
Time frame: 21 days post patch application
Population: Not all subjects tested all panels. No of subjects testing each panel; Panel 1- 105, Panel 2-111, Panel 3- 104, Panel 4- 109, Panel 5- 106
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| All Subjects | Number of Participants With Patch Test Responses | 0.40 mg/cm2 aluminum chloride | Number Positive | 0 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.40 mg/cm2 aluminum chloride | Number Negative | 105 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.40 mg/cm2 aluminum chloride | Number not tested | 16 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.12 mg/cm2 alumunum chloride | Number Positive | 0 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.12 mg/cm2 alumunum chloride | Number Negative | 105 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.12 mg/cm2 alumunum chloride | Number not tested | 16 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.36 mg/cm2 aluminum chloride | Number Positive | 1 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.36 mg/cm2 aluminum chloride | Number Negative | 104 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.36 mg/cm2 aluminum chloride | Number not tested | 16 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.72 mg/cm2 aluminum chloride | Number Positive | 4 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.72 mg/cm2 aluminum chloride | Number Negative | 101 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.72 mg/cm2 aluminum chloride | Number not tested | 16 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.047 mg/cm2 aluminum lactate | Number Positive | 0 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.047 mg/cm2 aluminum lactate | Number Negative | 105 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.047 mg/cm2 aluminum lactate | Number not tested | 16 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.14 mg/cm2 aluminum lactate | Number Positive | 0 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.14 mg/cm2 aluminum lactate | Number Negative | 105 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.14 mg/cm2 aluminum lactate | Number not tested | 16 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.42 mg/cm2 aluminum lactate | Number Positive | 0 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.42 mg/cm2 aluminum lactate | Number Negative | 105 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.42 mg/cm2 aluminum lactate | Number not tested | 16 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.84 mg/cm2 aluminum lactate | Number Positive | 0 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.84 mg/cm2 aluminum lactate | Number Negative | 105 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.84 mg/cm2 aluminum lactate | Number not tested | 16 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.013 mg/cm2 copper sulfate | Number Positive | 2 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.013 mg/cm2 copper sulfate | Number Negative | 109 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.013 mg/cm2 copper sulfate | Number not tested | 10 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.040 mg/cm2 copper sulfate | Number Positive | 9 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.040 mg/cm2 copper sulfate | Number Negative | 102 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.040 mg/cm2 copper sulfate | Number not tested | 10 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.80 mg/cm2 copper sulfate | Number Positive | 10 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.80 mg/cm2 copper sulfate | Number Negative | 101 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.80 mg/cm2 copper sulfate | Number not tested | 10 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.12 mg/cm2 copper sulfate | Number Positive | 16 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.12 mg/cm2 copper sulfate | Number Negative | 95 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.12 mg/cm2 copper sulfate | Number not tested | 10 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.013 mg/cm2 manganese chloride | Number Positive | 1 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.013 mg/cm2 manganese chloride | Number Negative | 103 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.013 mg/cm2 manganese chloride | Number not tested | 17 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.013 mg/cm2 zinc chloride | Number not tested | 10 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.040 mg/cm2 manganese chloride | Number Positive | 0 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.040 mg/cm2 manganese chloride | Number Negative | 103 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.040 mg/cm2 manganese chloride | Number not tested | 18 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.080 mg/cm2 manganese chloride | Number Positive | 4 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.080 mg/cm2 manganese chloride | Number Negative | 99 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.080 mg/cm2 manganese chloride | Number not tested | 18 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.24 mg/cm2 manganese chloride | Number Positive | 29 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.24 mg/cm2 manganese chloride | Number Negative | 74 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.24 mg/cm2 manganese chloride | Number not tested | 18 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.0067 mg/cm2 ammonium molybdate | Number Positive | 1 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.0067 mg/cm2 ammonium molybdate | Number Negative | 103 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.0067 mg/cm2 ammonium molybdate | Number not tested | 17 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.02 mg/cm2 ammonium molybdate | Number Positive | 0 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.02 mg/cm2 ammonium molybdate | Number Negative | 104 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.02 mg/cm2 ammonium molybdate | Number not tested | 17 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.040 mg/cm2 ammonium molybdate | Number Positive | 0 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.040 mg/cm2 ammonium molybdate | Number Negative | 103 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.040 mg/cm2 ammonium molybdate | Number not tested | 18 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.12 mg/cm2 ammonium molybdate | Number Positive | 0 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.12 mg/cm2 ammonium molybdate | Number Negative | 103 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.12 mg/cm2 ammonium molybdate | Number not tested | 18 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.0018 mg.cm2 tin chloride | Number Positive | 1 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.0018 mg.cm2 tin chloride | Number Negative | 110 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.0018 mg.cm2 tin chloride | Number not tested | 10 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.037 mg/cm2 tin chloride | Number Positive | 4 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.037 mg/cm2 tin chloride | Number Negative | 107 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.037 mg/cm2 tin chloride | Number not tested | 10 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.11 mg/cm2 tin chloride | Number Positive | 25 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.11 mg/cm2 tin chloride | Number Negative | 86 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.11 mg/cm2 tin chloride | Number not tested | 10 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.33 mg/cm2 tin chloride | Number Positive | 65 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.33 mg/cm2 tin chloride | Number Negative | 45 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.33 mg/cm2 tin chloride | Number not tested | 11 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.055 mg Ti/cm2 titanium citrate | Number Positive | 1 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.055 mg Ti/cm2 titanium citrate | Number Negative | 108 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.055 mg Ti/cm2 titanium citrate | Number not tested | 12 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.11 mg Ti/cm2 titanium citrate | Number Positive | 2 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.11 mg Ti/cm2 titanium citrate | Number Negative | 107 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.11 mg Ti/cm2 titanium citrate | Number not tested | 12 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.22 mg Ti/cm2 titanium citrate | Number Positive | 2 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.22 mg Ti/cm2 titanium citrate | Number Negative | 106 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.22 mg Ti/cm2 titanium citrate | Number not tested | 13 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.07 mg Ti/cm2 titanium lactate | Number Positive | 2 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.07 mg Ti/cm2 titanium lactate | Number Negative | 107 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.07 mg Ti/cm2 titanium lactate | Number not tested | 12 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.14 mg Ti/cm2 titanium lactate | Number Positive | 2 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.14 mg Ti/cm2 titanium lactate | Number Negative | 107 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.14 mg Ti/cm2 titanium lactate | Number not tested | 12 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.28 mg Ti/cm2 titanium lactate | Number Positive | 4 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.28 mg Ti/cm2 titanium lactate | Number Negative | 105 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.28 mg Ti/cm2 titanium lactate | Number not tested | 12 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.060 mg Ti/cm2 potassium titanium oxide oxalate | Number Positive | 1 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.060 mg Ti/cm2 potassium titanium oxide oxalate | Number Negative | 108 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.060 mg Ti/cm2 potassium titanium oxide oxalate | Number not tested | 12 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.12 mg Ti/cm2 potassium titanium oxide oxalate | Number Positive | 5 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.12 mg Ti/cm2 potassium titanium oxide oxalate | Number Negative | 104 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.12 mg Ti/cm2 potassium titanium oxide oxalate | Number not tested | 12 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.24 mg Ti/cm2 potassium titanium oxide oxalate | Number Positive | 2 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.24 mg Ti/cm2 potassium titanium oxide oxalate | Number Negative | 107 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.24 mg Ti/cm2 potassium titanium oxide oxalate | Number not tested | 12 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.055 mg Ti/cm2 ammonium titanium oxide oxalate | Number Positive | 13 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.055 mg Ti/cm2 ammonium titanium oxide oxalate | Number Negative | 96 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.055 mg Ti/cm2 ammonium titanium oxide oxalate | Number not tested | 12 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.11 mg Ti/cm2 ammonium titanium oxide oxalate | Number Positive | 21 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.11 mg Ti/cm2 ammonium titanium oxide oxalate | Number Negative | 88 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.11 mg Ti/cm2 ammonium titanium oxide oxalate | Number not tested | 12 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.22 mg Ti/cm2 ammonium titanium oxide oxalate | Number Positive | 18 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.22 mg Ti/cm2 ammonium titanium oxide oxalate | Number Negative | 91 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.22 mg Ti/cm2 ammonium titanium oxide oxalate | Number not tested | 12 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.0042 mg V/cm2 vanadium chloride | Number Positive | 0 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.0042 mg V/cm2 vanadium chloride | Number Negative | 106 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.0042 mg V/cm2 vanadium chloride | Number not tested | 15 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.0083 mg V/cm2 vanadium chloride | Number Positive | 4 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.0083 mg V/cm2 vanadium chloride | Number Negative | 102 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.0083 mg V/cm2 vanadium chloride | Number not tested | 15 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.025 mg V/cm2 vanadium chloride | Number Positive | 25 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.025 mg V/cm2 vanadium chloride | Number Negative | 81 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.025 mg V/cm2 vanadium chloride | Number not tested | 15 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.050 mg V/cm2 vanadium chloride | Number Positive | 46 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.050 mg V/cm2 vanadium chloride | Number Negative | 60 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.050 mg V/cm2 vanadium chloride | Number not tested | 15 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.0042 mg V/cm2 vanadium sulfate | Number Positive | 6 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.0042 mg V/cm2 vanadium sulfate | Number Negative | 100 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.0042 mg V/cm2 vanadium sulfate | Number not tested | 15 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.0083 mg V/cm2 vanadium sulfate | Number Positive | 7 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.0083 mg V/cm2 vanadium sulfate | Number Negative | 99 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.0083 mg V/cm2 vanadium sulfate | Number not tested | 15 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.025 mg V/cm2 vanadium sulfate | Number Positive | 10 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.025 mg V/cm2 vanadium sulfate | Number Negative | 96 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.025 mg V/cm2 vanadium sulfate | Number not tested | 15 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.050 mg V/cm2 vanadium sulfate | Number Positive | 30 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.050 mg V/cm2 vanadium sulfate | Number Negative | 76 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.050 mg V/cm2 vanadium sulfate | Number not tested | 15 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.013 mg/cm2 zinc chloride | Number Positive | 2 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.013 mg/cm2 zinc chloride | Number Negative | 109 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.040 mg/cm2 zinc chloride | Number Positive | 7 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.040 mg/cm2 zinc chloride | Number Negative | 104 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.040 mg/cm2 zinc chloride | Number not tested | 10 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.080 mg/cm2 zinc chloride | Number Positive | 13 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.080 mg/cm2 zinc chloride | Number Negative | 98 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.080 mg/cm2 zinc chloride | Number not tested | 10 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.24 mg/cm2 zinc chloride | Number Positive | 69 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.24 mg/cm2 zinc chloride | Number Negative | 42 Participants |
| All Subjects | Number of Participants With Patch Test Responses | 0.24 mg/cm2 zinc chloride | Number not tested | 10 Participants |
Comparison: Comparison between 0.12 mg/cm2 copper sulfate and copper sulfate 2% in petrolatum95% CI: [-0.01, 0.58]
Comparison: Comparison between 0.24 mg/cm2 manganese chloride and manganese chloride 2% in petrolatum95% CI: [0.24, 0.66]
Comparison: Comparison between 0.33 mg/cm2 tin chloride and tin chloride 1% in petrolatum95% CI: [0.07, 0.38]
Comparison: Comparison between 0.22 mg Ti/cm2 ammonium titanium oxide oxalate and ammnium titanium oxide oxalate 19% in petrolatum95% CI: [0.15, 0.65]
Comparison: Comparison between 0.050 mg/cm2 vanadium sulfate and vanadium sulfate 1.5% in petrolatum95% CI: [0.3, 0.73]
Comparison: Comparison betweenm 0.24 mg/cm2 zinc chloride and zinc chloride 2% in petrolatum95% CI: [0.07, 0.38]
Secondary
Chip Irritation
Chip irritation was measured according to the following scale: None- No irritation, Weak- Faint to definite pink erythema, Moderate- Moderate erythema, definite redness, Strong- Severe erythema, very intense redness. Following visit 6, the Investigators rated Chip irritation based on the overall trend observed at visits 2-6. Irritation at visit 2 that resolved by visit 3 was considered none. Skin under occlusion from an adhesive material would be expected to have minimal irritation shortly after the panel is removed. Irritation that persisted or increased in severity beyond visit 3 but resolved by the following visit would have been rated as irritant. An allergic response was considered if irritation persisted beyond visit 3, increased in severity and had symptoms consistent with criteria used to score positive skin reactions according to standard patch testing guidelines established by the International Contact Dermatitis Research Group.
Time frame: Visit 2 (day 2), visit 3 (day 3-4), visit 4 (day 7-8) visit 5 (day 10-14), visit 6 (day 19-23) with overall assessment by the Investigator following visit 6
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| All Subjects | Chip Irritation | Panel 2 Chip Irritation | None | 111 Participants |
| All Subjects | Chip Irritation | Panel 1 Chip Irritation | None | 105 Participants |
| All Subjects | Chip Irritation | Panel 1 Chip Irritation | Irritant | 0 Participants |
| All Subjects | Chip Irritation | Panel 1 Chip Irritation | Allergic | 0 Participants |
| All Subjects | Chip Irritation | Panel 1 Chip Irritation | Not Tested | 16 Participants |
| All Subjects | Chip Irritation | Panel 2 Chip Irritation | Irritant | 0 Participants |
| All Subjects | Chip Irritation | Panel 2 Chip Irritation | Allergic | 0 Participants |
| All Subjects | Chip Irritation | Panel 2 Chip Irritation | Not Tested | 10 Participants |
| All Subjects | Chip Irritation | Panel 3 Chip Irritation | None | 104 Participants |
| All Subjects | Chip Irritation | Panel 3 Chip Irritation | Irritant | 0 Participants |
| All Subjects | Chip Irritation | Panel 3 Chip Irritation | Allergic | 0 Participants |
| All Subjects | Chip Irritation | Panel 3 Chip Irritation | Not Tested | 17 Participants |
| All Subjects | Chip Irritation | Panel 4 Chip Irritation | None | 109 Participants |
| All Subjects | Chip Irritation | Panel 4 Chip Irritation | Irritant | 0 Participants |
| All Subjects | Chip Irritation | Panel 4 Chip Irritation | Allergic | 0 Participants |
| All Subjects | Chip Irritation | Panel 4 Chip Irritation | Not Tested | 12 Participants |
| All Subjects | Chip Irritation | Panel 5 Chip Irritation | None | 106 Participants |
| All Subjects | Chip Irritation | Panel 5 Chip Irritation | Irritant | 0 Participants |
| All Subjects | Chip Irritation | Panel 5 Chip Irritation | Allergic | 0 Participants |
| All Subjects | Chip Irritation | Panel 5 Chip Irritation | Not Tested | 15 Participants |
| All Subjects | Chip Irritation | Panel 6 Chip Irritation | None | 120 Participants |
| All Subjects | Chip Irritation | Panel 6 Chip Irritation | Irritant | 0 Participants |
| All Subjects | Chip Irritation | Panel 6 Chip Irritation | Allergic | 0 Participants |
| All Subjects | Chip Irritation | Panel 6 Chip Irritation | Not Tested | 1 Participants |
Secondary
Number of Subjects With Panel Adhesion
Panel Adhesion was measured at Visit 2 (day 2) prior to panel removal according to the following scale: Excellent- Skin contact good; all tape edges adherent; all allergens in contact with the skin, Good- Skin contact acceptable; some tape edges lifting; all allergens in contact with the skin, Poor- Little to no skin contact with panel; one or more allergens not in contact with the skin, Detached- Panel completely off the skin; none of the allergens in contact with the skin
Time frame: Day 2, visit 2 prior to panel removal
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| All Subjects | Number of Subjects With Panel Adhesion | Panel 6 Adhesion | Poor | 2 Participants |
| All Subjects | Number of Subjects With Panel Adhesion | Panel 1 Adhesion | Excellent | 102 Participants |
| All Subjects | Number of Subjects With Panel Adhesion | Panel 1 Adhesion | Good | 1 Participants |
| All Subjects | Number of Subjects With Panel Adhesion | Panel 1 Adhesion | Poor | 2 Participants |
| All Subjects | Number of Subjects With Panel Adhesion | Panel 1 Adhesion | Detached | 0 Participants |
| All Subjects | Number of Subjects With Panel Adhesion | Panel 1 Adhesion | Not Tested | 16 Participants |
| All Subjects | Number of Subjects With Panel Adhesion | Panel 2 Adhesion | Excellent | 103 Participants |
| All Subjects | Number of Subjects With Panel Adhesion | Panel 2 Adhesion | Good | 3 Participants |
| All Subjects | Number of Subjects With Panel Adhesion | Panel 2 Adhesion | Poor | 5 Participants |
| All Subjects | Number of Subjects With Panel Adhesion | Panel 2 Adhesion | Detached | 0 Participants |
| All Subjects | Number of Subjects With Panel Adhesion | Panel 2 Adhesion | Not Tested | 10 Participants |
| All Subjects | Number of Subjects With Panel Adhesion | Panel 3 Adhesion | Excellent | 98 Participants |
| All Subjects | Number of Subjects With Panel Adhesion | Panel 3 Adhesion | Good | 3 Participants |
| All Subjects | Number of Subjects With Panel Adhesion | Panel 3 Adhesion | Poor | 3 Participants |
| All Subjects | Number of Subjects With Panel Adhesion | Panel 3 Adhesion | Detached | 0 Participants |
| All Subjects | Number of Subjects With Panel Adhesion | Panel 3 Adhesion | Not Tested | 17 Participants |
| All Subjects | Number of Subjects With Panel Adhesion | Panel 4 Adhesion | Excellent | 105 Participants |
| All Subjects | Number of Subjects With Panel Adhesion | Panel 4 Adhesion | Good | 1 Participants |
| All Subjects | Number of Subjects With Panel Adhesion | Panel 4 Adhesion | Poor | 3 Participants |
| All Subjects | Number of Subjects With Panel Adhesion | Panel 4 Adhesion | Detached | 0 Participants |
| All Subjects | Number of Subjects With Panel Adhesion | Panel 4 Adhesion | Not Tested | 12 Participants |
| All Subjects | Number of Subjects With Panel Adhesion | Panel 5 Adhesion | Excellent | 100 Participants |
| All Subjects | Number of Subjects With Panel Adhesion | Panel 5 Adhesion | Good | 6 Participants |
| All Subjects | Number of Subjects With Panel Adhesion | Panel 5 Adhesion | Poor | 0 Participants |
| All Subjects | Number of Subjects With Panel Adhesion | Panel 5 Adhesion | Detached | 0 Participants |
| All Subjects | Number of Subjects With Panel Adhesion | Panel 5 Adhesion | Not Tested | 15 Participants |
| All Subjects | Number of Subjects With Panel Adhesion | Panel 6 Adhesion | Excellent | 113 Participants |
| All Subjects | Number of Subjects With Panel Adhesion | Panel 6 Adhesion | Good | 5 Participants |
| All Subjects | Number of Subjects With Panel Adhesion | Panel 6 Adhesion | Detached | 0 Participants |
| All Subjects | Number of Subjects With Panel Adhesion | Panel 6 Adhesion | Not Tested | 1 Participants |
Secondary
Tape Irritation
Tape irritation was measured according to the following scale: None- No irritation, Weak- Faint to definite pink erythema, Moderate- Moderate erythema, definite redness, Strong- Severe erythema, very intense redness. Following visit 6, the Investigators rated tape irritation based on the overall trend observed at visits 2-6. Irritation at visit 2 that resolved by visit 3 was considered none. Skin under occlusion from an adhesive material would be expected to have minimal irritation shortly after the panel is removed. Irritation that persisted or increased in severity beyond visit 3 but resolved by the following visit would have been rated as irritant. An allergic response was considered if irritation persisted beyond visit 3, increased in severity and had symptoms consistent with criteria used to score positive skin reactions according to standard patch testing guidelines established by the International Contact Dermatitis Research Group.
Time frame: Visit 2 (day 2), visit 3 (day 3-4), visit 4 (day 7-8) visit 5 (day 10-14), visit 6 (day 19-23) with overall assessment by the Investigator following visit 6
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| All Subjects | Tape Irritation | Panel 1 Tape Irritation | None | 103 Participants |
| All Subjects | Tape Irritation | Panel 1 Tape Irritation | Irritant | 2 Participants |
| All Subjects | Tape Irritation | Panel 1 Tape Irritation | Allergic | 0 Participants |
| All Subjects | Tape Irritation | Panel 1 Tape Irritation | Not Tested | 16 Participants |
| All Subjects | Tape Irritation | Panel 2 Tape Irritation | None | 109 Participants |
| All Subjects | Tape Irritation | Panel 2 Tape Irritation | Irritant | 2 Participants |
| All Subjects | Tape Irritation | Panel 2 Tape Irritation | Allergic | 0 Participants |
| All Subjects | Tape Irritation | Panel 2 Tape Irritation | Not Tested | 10 Participants |
| All Subjects | Tape Irritation | Panel 3 Tape Irritation | None | 103 Participants |
| All Subjects | Tape Irritation | Panel 3 Tape Irritation | Irritant | 1 Participants |
| All Subjects | Tape Irritation | Panel 3 Tape Irritation | Allergic | 0 Participants |
| All Subjects | Tape Irritation | Panel 3 Tape Irritation | Not Tested | 17 Participants |
| All Subjects | Tape Irritation | Panel 4 Tape Irritation | None | 108 Participants |
| All Subjects | Tape Irritation | Panel 4 Tape Irritation | Irritant | 1 Participants |
| All Subjects | Tape Irritation | Panel 4 Tape Irritation | Allergic | 0 Participants |
| All Subjects | Tape Irritation | Panel 4 Tape Irritation | Not Tested | 12 Participants |
| All Subjects | Tape Irritation | Panel 5 Tape Irritation | None | 105 Participants |
| All Subjects | Tape Irritation | Panel 5 Tape Irritation | Irritant | 1 Participants |
| All Subjects | Tape Irritation | Panel 5 Tape Irritation | Allergic | 0 Participants |
| All Subjects | Tape Irritation | Panel 5 Tape Irritation | Not Tested | 15 Participants |
| All Subjects | Tape Irritation | Panel 6 Tape Irritation | None | 119 Participants |
| All Subjects | Tape Irritation | Panel 6 Tape Irritation | Irritant | 1 Participants |
| All Subjects | Tape Irritation | Panel 6 Tape Irritation | Allergic | 0 Participants |
| All Subjects | Tape Irritation | Panel 6 Tape Irritation | Not Tested | 1 Participants |