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48-hour application of metal allergen patches to test for potential allergic responses.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metal Allergen Epicutaneous Patch | Experimental | 8 allergens were tested. Not all subjects tested each allergen. Section reports number of subjects with positive responses to each allergen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metal Allergen Epicutaneous Patch | Biological | 48 hour application of metal allergen patch to diagnose contact dermatitis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 21 days post patch application |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia L Norris, MD | Oregon Health & Science University, Portland USA | Principal Investigator |
| Karin Pacheco, MD | National Jewish Health School of Medicine, Colorado USA | Principal Investigator |
| Andreas Bircher, MD | University Hospital, Basel, Switzerland | Principal Investigator |
| Paolo Pigatto, MD | University of Milano, Italy | Principal Investigator |
| Thomas Rustemeyer, MD, PhD | VU University Medical Center, Netherlands | Principal Investigator |
| Peter Thomas, MD | Ludwig-Maximilians-Universität München, Germany | Principal Investigator |
| Maki Hosoki, DDS, PhD | Tokushima University Graduate School, Japan | Principal Investigator |
| Risa Tamagawa-Mineoka, MD | Kyoto Prefectural University of Medicine, Japan | Principal Investigator |
| Akiko Yagami, MD, PhD | Fujita Health University School of Medicine, Japan |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Jewish Health, University of Colorado Denver | Denver | Colorado | 80206 | United States | ||
| Ludwig-Maximilians-Universitat Munchen |
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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
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline population: Enrolled subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | Posted | Count of Participants | Participants | 21 days post patch application |
|
Day 2-21
Because subjects were patched with multiple allergens/doses it is not possible to relate adverse events to a single allergen/dose
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Subjects | Subjects patched with at least 1 patch test panel were included in adverse event reporting. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ductal carcinoma of right breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathryn Shannon | Allerderm (dba) SmartPractice | 6022250595 | 7208 | kshannon@smartpractice.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 27, 2018 | May 4, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 30, 2019 | May 4, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D004485 | Eczema |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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| Day 2, visit 2 prior to panel removal |
| 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. | 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 | 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. | 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 |
| Principal Investigator |
| Munich |
| 80337 |
| Germany |
| University of Milano | Milan | 20161 | Italy |
| Fujita Health University School of Medicine | Aichi | 470-1192 | Japan |
| Kyoto Prefectural University of Medicine | Kyoto | 602-8566 | Japan |
| Tokushima University Graduate School | Tokushima | 770-8504 | Japan |
| VU University Medical Center | Amsterdam | NL1081 | Netherlands |
| University Hospital Basel Allergology Unit | Basel | CH-4031 | Switzerland |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Subjects with past allergic response or suspicion of allergy | Count of Participants | 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 | Posted | Count of Participants | Participants | Day 2, visit 2 prior to panel removal |
|
|
|
| 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. | Posted | Count of Participants | Participants | 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 |
|
|
|
| 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. | Posted | Count of Participants | Participants | 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 |
|
|
|
| 0 |
| 122 |
| 1 |
| 122 |
| 30 |
| 122 |
| Dry eye | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hordeolum | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Abdominal pain, upper | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Glossitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Periodontal inflammation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Application site erythema | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Inflammation | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Influenza-like illness | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dyshidrotic eczema | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Endodontic tooth pain | Surgical and medical procedures | MedDRA 20.0 | Systematic Assessment |
|
| Therapeutic nerve ablation | Surgical and medical procedures | MedDRA 20.0 | Systematic Assessment |
|
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| Detached |
|
| Not Tested |
|
| Panel 2 Adhesion |
|
| Panel 3 Adhesion |
|
| Panel 4 Adhesion |
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| Panel 5 Adhesion |
|
| Panel 6 Adhesion |
|
| Not Tested |
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| Panel 2 Tape Irritation |
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| Panel 3 Tape Irritation |
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| Panel 4 Tape Irritation |
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| Panel 5 Tape Irritation |
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| Panel 6 Tape Irritation |
|
| Not Tested |
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| Panel 2 Chip Irritation |
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| Panel 3 Chip Irritation |
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| Panel 4 Chip Irritation |
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| Panel 5 Chip Irritation |
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| Panel 6 Chip Irritation |
|