Dermatitis, Contact
Conditions
Keywords
allergic, contact dermatitis, contact allergy, Type IV, Children, TRUE TEST
Brief summary
Open, prospective, single-site, non-randomized study of the efficacy and safety of T.R.U.E. TEST allergens in children and adolescents ages 6-18.
Detailed description
Three T.R.U.E. TEST panels (1.1, 2.1 and 3.1) containing 28 allergens and a negative control will be applied to the skin on the subject's back and worn for approximately 48 hours. Patch test site skin reactions will be evaluated at days 2, 3 (+1), 7 and 21 following panel application
Interventions
BIOLOGICALT.R.U.E. Test
48 hour application of 28 allergens and negative control
Sponsors
Allerderm
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Symptoms and history potentially consistent with allergic contact dermatitis based on symptoms and clinical history (i.e., subjects are visiting the clinic/physician to diagnose, treat or resolve this condition). * Children and adolescents 6 to 18 years of age, and 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 immunosuppressive 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 |
|---|---|---|
| Positive Reactions: Nickel Sulfate | Visit 3: 3-4 after patch application, Visit 4: 7 days after patch application | Number of subjects with positive reactions (score of 1+, 2+ or 3+) at visit 3 and/or visit 4 |
| Positive Reactions: Neomycin Sulfate | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | Number of subjects with positive reactions (score of 1+, 2+ or 3+) at visit 3 and/or visit 4 |
| Positive Reactions: Wool Alcohol | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 |
| Positive Reactions: Potassium Dichromate | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 |
| Positive Reactions: Caine Mix | Visit 3: 72-96 hours after patch application, Visit 4: 1 week after patch application | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 |
| Positive Reactions: Fragrance Mix | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 |
| Positive Reactions: Colophony | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 |
| Positive Reactions: Paraben Mix | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 |
| Positive Reactions: Negative Control | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | Number of subjects with positive reactions recorded at visit 3 and/or visit 4. |
| Positive Reactions: Balsam of Peru | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 |
| Positive Reactions: Ethylenediamine Dihydrochloride | Visit 3: 3-4 days after patch application, Visit 4: 7 days week after patch application | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 |
| Positive Reactions: Cobalt Dichloride | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 |
| Positive Reactions: P-tert Butylphenol Formadehyde Resin | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 |
| Positive Reactions: Epoxy Resin | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 |
| Positive Reactions: Carba Mix | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 |
| Positive Reactions: Black Rubber Mix | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 |
| Positive Reactions: Cl+Me-Isothiazolinone | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 |
| Positive Reactions: Quaternium-15 | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 |
| Positive Reactions: Mercaptobenzothiazole | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 |
| Positive Reactions: p-Phenylenediamine | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 |
| Positive Reactions: Formaldehyde | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 |
| Positive Reactions: Mercapto Mix | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | Number of subjects with positive reactions at visit 3 and/or visit 4 |
| Positive Reactions: Thimerosal | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 |
| Positive Reactions: Thiuram Mix | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 |
| Positive Reactions: Diazolidinyl Urea | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 |
| Positive Reactions: Imidazolidinyl Urea | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | Number of subjects with positive reactions at visit 3 and/or visit 4 |
| Positive Reactions: Budesonide | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 |
| Positive Reactions: Tixocortol-21-pivalate | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | Number of subjects with positive reactions at visit 3 and/or visit 4 |
| Positive Reactions: Quinoline Mix | Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application | Number of subjects with positive reactions recorded at visit 3 and/or visit 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Persistent Reactions: Nickel Sulfate | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. |
| Persistent Reactions: Neomycin Sulfate | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. |
| Persistent Reactions: Wool Alcohol | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. |
| Persistent Reactions: Potassium Dichromate | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. |
| Persistent Reactions: Caine Mix | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. |
| Persistent Reactions: Fragrance Mix | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. |
| Persistent Reactions: Colophony | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. |
| Persistent Reactions: Paraben Mix | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. |
| Persistent Reactions: Negative Control | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. |
| Persistent Reactions: Balsam of Peru | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. |
| Persistent Reactions: Ethylenediamine Dihydrochloride | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. |
| Persistent Reactions: Cobalt Dichloride | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. |
| Persistent Reactions: P-tert Butylphenol Formadehyde Resin | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. |
| Persistent Reactions: Epoxy Resin | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. |
| Persistent Reactions: Carba Mix | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. |
| Persistent Reactions: Black Rubber Mix | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. |
| Persistent Reactions: Cl+Me-Isothiazolinone | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. |
| Persistent Reactions: Quaternium-15 | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. |
| Persistent Reactions: p-Phenylenediamine | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. |
| Persistent Reactions: Formaldehyde | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. |
| Persistent Reactions: Mercapto Mix | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. |
| Persistent Reactions: Thimerosal | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. |
| Persistent Reactions: Thiuram Mix | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. |
| Persistent Reactions: Diazolidinyl Urea | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. |
| Persistent Reactions: Imidazolidinyl Urea | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. |
| Persistent Reactions: Budesonide | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. |
| Persistent Reactions: Tixocortol-21-pivalate | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. |
| Late Reactions: Nickel Sulfate | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. |
| Persistent Reactions: Mercaptobenzothiazole | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. |
| Panel Adhesion Evaluation | Visit 2 (day 1) prior to panel removal. | Panel Adhesion was evaluated according to the following score scale: Off: Test panel fell off, Poor: little to no skin to panel contact, Fair: skin to panel contact variable, tape edges lifting, Good: skin contact acceptable, some tape edges loose; Excellent, skin contact good, tape edges adherent. |
| Panel Irritation | Visit 2 (day 1) following to panel removal. | Panel Irritation was scored according to the following descriptors; None, Weak, Moderate, Strong (not defined in protocol) |
| Subject Reported Itching and Burning | Visit 2 (day 1) following to panel removal. | Subject reported itching/burning was scored according to the following descriptors; None, Weak, Moderate, Strong (not defined in protocol) |
| Persistent Reactions: Quinoline Mix | Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application | Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit. |
| Late Reactions: Neomycin Sulfate | Visit 4: 7 days after patch application | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. |
| Late Reactions: Wool Alcohol | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. |
| Late Reactions: Potassium Dichromate | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. |
| Late Reactions: Caine Mix | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. |
| Late Reactions: Fragrance Mix | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. |
| Late Reactions: Colophony | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. |
| Late Reactions: Paraben Mix | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. |
| Late Reactions: Negative Control | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. |
| Late Reactions: Balsam of Peru | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. |
| Late Reactions: Ethylenediamine Dihydrochloride | Visit 4: 7 days week after patch application or Visit 5: 21 days after patch application | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. |
| Late Reactions: Cobalt Dichloride | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. |
| Late Reactions: P-tert Butylphenol Formadehyde Resin | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. |
| Late Reactions: Epoxy Resin | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. |
| Late Reactions: Carba Mix | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. |
| Late Reactions: Black Rubber Mix | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. |
| Late Reactions: Cl+Me-Isothiazolinone | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. |
| Late Reactions: Quaternium-15 | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. |
| Late Reactions: Mercaptobenzothiazole | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. |
| Late Reactions: p-Phenylenediamine | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. |
| Late Reactions: Formaldehyde | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. |
| Late Reactions: Mercapto Mix | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. |
| Late Reactions: Thimerosal | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. |
| Late Reactions: Thiuram Mix | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. |
| Late Reactions: Diazolidinyl Urea | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. |
| Late Reactions: Imidazolidinyl Urea | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. |
| Late Reactions: Budesonide | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. |
| Late Reactions: Tixocortol-21-pivalate | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. |
| Late Reactions: Quinoline Mix | Visit 4: 7 days after patch application or Visit 5: 21 days after patch application | Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later. |
Countries
United States
Participant flow
Recruitment details
Single Site- Rady Children's Hospital Recruiting Period-09 December 2008 (first subject enrolled) 27 October 2009 (last subject exited)
Pre-assignment details
No significant events or approaches
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Study All subjects were patched with TRUE Test panels 1.1, 2.1 and 3.1 | 102 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Single Arm Study |
|---|---|
| Age, Categorical <=18 years | 102 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 11.6 years STANDARD_DEVIATION 3.61 |
| Region of Enrollment United States | 102 participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 42 / 102 |
| serious Total, serious adverse events | 0 / 102 |
Outcome results
Primary
Positive Reactions: Balsam of Peru
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Positive Reactions: Balsam of Peru | 11 participants |
Primary
Positive Reactions: Black Rubber Mix
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Positive Reactions: Black Rubber Mix | 2 participants |
Primary
Positive Reactions: Budesonide
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Positive Reactions: Budesonide | 1 participants |
Primary
Positive Reactions: Caine Mix
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time frame: Visit 3: 72-96 hours after patch application, Visit 4: 1 week after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Positive Reactions: Caine Mix | 0 participants |
Primary
Positive Reactions: Carba Mix
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Positive Reactions: Carba Mix | 7 participants |
Primary
Positive Reactions: Cl+Me-Isothiazolinone
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Positive Reactions: Cl+Me-Isothiazolinone | 4 participants |
Primary
Positive Reactions: Cobalt Dichloride
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Positive Reactions: Cobalt Dichloride | 13 participants |
Primary
Positive Reactions: Colophony
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Positive Reactions: Colophony | 9 participants |
Primary
Positive Reactions: Diazolidinyl Urea
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Positive Reactions: Diazolidinyl Urea | 5 participants |
Primary
Positive Reactions: Epoxy Resin
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Positive Reactions: Epoxy Resin | 4 participants |
Primary
Positive Reactions: Ethylenediamine Dihydrochloride
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days week after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Positive Reactions: Ethylenediamine Dihydrochloride | 5 participants |
Primary
Positive Reactions: Formaldehyde
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Positive Reactions: Formaldehyde | 7 participants |
Primary
Positive Reactions: Fragrance Mix
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Positive Reactions: Fragrance Mix | 13 participants |
Primary
Positive Reactions: Imidazolidinyl Urea
Number of subjects with positive reactions at visit 3 and/or visit 4
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Positive Reactions: Imidazolidinyl Urea | 2 participants |
Primary
Positive Reactions: Mercaptobenzothiazole
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Positive Reactions: Mercaptobenzothiazole | 2 participants |
Primary
Positive Reactions: Mercapto Mix
Number of subjects with positive reactions at visit 3 and/or visit 4
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Positive Reactions: Mercapto Mix | 2 participants |
Primary
Positive Reactions: Negative Control
Number of subjects with positive reactions recorded at visit 3 and/or visit 4.
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Positive Reactions: Negative Control | 0 participants |
Primary
Positive Reactions: Neomycin Sulfate
Number of subjects with positive reactions (score of 1+, 2+ or 3+) at visit 3 and/or visit 4
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Positive Reactions: Neomycin Sulfate | 8 participants |
Primary
Positive Reactions: Nickel Sulfate
Number of subjects with positive reactions (score of 1+, 2+ or 3+) at visit 3 and/or visit 4
Time frame: Visit 3: 3-4 after patch application, Visit 4: 7 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Positive Reactions: Nickel Sulfate | 30 participants |
Primary
Positive Reactions: Paraben Mix
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Positive Reactions: Paraben Mix | 2 participants |
Primary
Positive Reactions: Potassium Dichromate
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Positive Reactions: Potassium Dichromate | 9 participants |
Primary
Positive Reactions: p-Phenylenediamine
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Positive Reactions: p-Phenylenediamine | 2 participants |
Primary
Positive Reactions: P-tert Butylphenol Formadehyde Resin
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Positive Reactions: P-tert Butylphenol Formadehyde Resin | 17 participants |
Primary
Positive Reactions: Quaternium-15
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Positive Reactions: Quaternium-15 | 4 participants |
Primary
Positive Reactions: Quinoline Mix
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Positive Reactions: Quinoline Mix | 1 participants |
Primary
Positive Reactions: Thimerosal
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Positive Reactions: Thimerosal | 4 participants |
Primary
Positive Reactions: Thiuram Mix
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Positive Reactions: Thiuram Mix | 7 participants |
Primary
Positive Reactions: Tixocortol-21-pivalate
Number of subjects with positive reactions at visit 3 and/or visit 4
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Positive Reactions: Tixocortol-21-pivalate | 8 participants |
Primary
Positive Reactions: Wool Alcohol
Number of subjects with positive reactions recorded at visit 3 and/or visit 4
Time frame: Visit 3: 3-4 days after patch application, Visit 4: 7 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Positive Reactions: Wool Alcohol | 16 participants |
Secondary
Late Reactions: Balsam of Peru
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Late Reactions: Balsam of Peru | 0 participants |
Secondary
Late Reactions: Black Rubber Mix
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Late Reactions: Black Rubber Mix | 0 participants |
Secondary
Late Reactions: Budesonide
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Late Reactions: Budesonide | 0 participants |
Secondary
Late Reactions: Caine Mix
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Late Reactions: Caine Mix | 0 participants |
Secondary
Late Reactions: Carba Mix
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Late Reactions: Carba Mix | 0 participants |
Secondary
Late Reactions: Cl+Me-Isothiazolinone
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Late Reactions: Cl+Me-Isothiazolinone | 0 participants |
Secondary
Late Reactions: Cobalt Dichloride
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Late Reactions: Cobalt Dichloride | 1 participants |
Secondary
Late Reactions: Colophony
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Late Reactions: Colophony | 0 participants |
Secondary
Late Reactions: Diazolidinyl Urea
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Late Reactions: Diazolidinyl Urea | 1 participants |
Secondary
Late Reactions: Epoxy Resin
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Late Reactions: Epoxy Resin | 1 participants |
Secondary
Late Reactions: Ethylenediamine Dihydrochloride
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time frame: Visit 4: 7 days week after patch application or Visit 5: 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Late Reactions: Ethylenediamine Dihydrochloride | 0 participants |
Secondary
Late Reactions: Formaldehyde
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Late Reactions: Formaldehyde | 2 participants |
Secondary
Late Reactions: Fragrance Mix
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Late Reactions: Fragrance Mix | 0 participants |
Secondary
Late Reactions: Imidazolidinyl Urea
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Late Reactions: Imidazolidinyl Urea | 1 participants |
Secondary
Late Reactions: Mercaptobenzothiazole
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Late Reactions: Mercaptobenzothiazole | 0 participants |
Secondary
Late Reactions: Mercapto Mix
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Late Reactions: Mercapto Mix | 0 participants |
Secondary
Late Reactions: Negative Control
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Late Reactions: Negative Control | 0 participants |
Secondary
Late Reactions: Neomycin Sulfate
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time frame: Visit 4: 7 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Late Reactions: Neomycin Sulfate | 1 participants |
Secondary
Late Reactions: Nickel Sulfate
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Late Reactions: Nickel Sulfate | 1 participants |
Secondary
Late Reactions: Paraben Mix
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Late Reactions: Paraben Mix | 0 participants |
Secondary
Late Reactions: Potassium Dichromate
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Late Reactions: Potassium Dichromate | 0 participants |
Secondary
Late Reactions: p-Phenylenediamine
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Late Reactions: p-Phenylenediamine | 0 participants |
Secondary
Late Reactions: P-tert Butylphenol Formadehyde Resin
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Late Reactions: P-tert Butylphenol Formadehyde Resin | 1 participants |
Secondary
Late Reactions: Quaternium-15
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Late Reactions: Quaternium-15 | 1 participants |
Secondary
Late Reactions: Quinoline Mix
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Late Reactions: Quinoline Mix | 0 participants |
Secondary
Late Reactions: Thimerosal
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Late Reactions: Thimerosal | 0 participants |
Secondary
Late Reactions: Thiuram Mix
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Late Reactions: Thiuram Mix | 1 participants |
Secondary
Late Reactions: Tixocortol-21-pivalate
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Late Reactions: Tixocortol-21-pivalate | 0 participants |
Secondary
Late Reactions: Wool Alcohol
Number of subjects with late reactions, defined as a positive reaction that initially occurs at day 7 (visit 4) or later.
Time frame: Visit 4: 7 days after patch application or Visit 5: 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Late Reactions: Wool Alcohol | 0 participants |
Secondary
Panel Adhesion Evaluation
Panel Adhesion was evaluated according to the following score scale: Off: Test panel fell off, Poor: little to no skin to panel contact, Fair: skin to panel contact variable, tape edges lifting, Good: skin contact acceptable, some tape edges loose; Excellent, skin contact good, tape edges adherent.
Time frame: Visit 2 (day 1) prior to panel removal.
Population: All subjects who completed the study are included in the analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| All Subjects | Panel Adhesion Evaluation | Panel 1 Adhesion Scores | Excellent | 71 Participants |
| All Subjects | Panel Adhesion Evaluation | Panel 1 Adhesion Scores | Good | 19 Participants |
| All Subjects | Panel Adhesion Evaluation | Panel 1 Adhesion Scores | Fair | 8 Participants |
| All Subjects | Panel Adhesion Evaluation | Panel 1 Adhesion Scores | Poor | 2 Participants |
| All Subjects | Panel Adhesion Evaluation | Panel 1 Adhesion Scores | Fell off | 0 Participants |
| All Subjects | Panel Adhesion Evaluation | Panel 2 Adhesion Scores | Excellent | 72 Participants |
| All Subjects | Panel Adhesion Evaluation | Panel 2 Adhesion Scores | Good | 19 Participants |
| All Subjects | Panel Adhesion Evaluation | Panel 2 Adhesion Scores | Fair | 9 Participants |
| All Subjects | Panel Adhesion Evaluation | Panel 2 Adhesion Scores | Poor | 0 Participants |
| All Subjects | Panel Adhesion Evaluation | Panel 2 Adhesion Scores | Fell off | 0 Participants |
| All Subjects | Panel Adhesion Evaluation | Panel 3 Adhesion Scores | Excellent | 82 Participants |
| All Subjects | Panel Adhesion Evaluation | Panel 3 Adhesion Scores | Good | 14 Participants |
| All Subjects | Panel Adhesion Evaluation | Panel 3 Adhesion Scores | Fair | 3 Participants |
| All Subjects | Panel Adhesion Evaluation | Panel 3 Adhesion Scores | Poor | 1 Participants |
| All Subjects | Panel Adhesion Evaluation | Panel 3 Adhesion Scores | Fell off | 0 Participants |
Secondary
Panel Irritation
Panel Irritation was scored according to the following descriptors; None, Weak, Moderate, Strong (not defined in protocol)
Time frame: Visit 2 (day 1) following to panel removal.
Population: All subjects who completed the study are included in the analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| All Subjects | Panel Irritation | Panel 1 Irritation | None | 38 Participants |
| All Subjects | Panel Irritation | Panel 1 Irritation | Weak | 43 Participants |
| All Subjects | Panel Irritation | Panel 1 Irritation | Moderate | 16 Participants |
| All Subjects | Panel Irritation | Panel 1 Irritation | Strong | 3 Participants |
| All Subjects | Panel Irritation | Panel 2 Irritation | None | 37 Participants |
| All Subjects | Panel Irritation | Panel 2 Irritation | Weak | 43 Participants |
| All Subjects | Panel Irritation | Panel 2 Irritation | Moderate | 16 Participants |
| All Subjects | Panel Irritation | Panel 2 Irritation | Strong | 4 Participants |
| All Subjects | Panel Irritation | Panel 3 Irritation | None | 40 Participants |
| All Subjects | Panel Irritation | Panel 3 Irritation | Weak | 40 Participants |
| All Subjects | Panel Irritation | Panel 3 Irritation | Moderate | 18 Participants |
| All Subjects | Panel Irritation | Panel 3 Irritation | Strong | 2 Participants |
Secondary
Persistent Reactions: Balsam of Peru
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Persistent Reactions: Balsam of Peru | 2 participants |
Secondary
Persistent Reactions: Black Rubber Mix
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Persistent Reactions: Black Rubber Mix | 0 participants |
Secondary
Persistent Reactions: Budesonide
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Persistent Reactions: Budesonide | 1 participants |
Secondary
Persistent Reactions: Caine Mix
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Persistent Reactions: Caine Mix | 0 participants |
Secondary
Persistent Reactions: Carba Mix
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Persistent Reactions: Carba Mix | 1 participants |
Secondary
Persistent Reactions: Cl+Me-Isothiazolinone
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Persistent Reactions: Cl+Me-Isothiazolinone | 3 participants |
Secondary
Persistent Reactions: Cobalt Dichloride
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Persistent Reactions: Cobalt Dichloride | 5 participants |
Secondary
Persistent Reactions: Colophony
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Persistent Reactions: Colophony | 4 participants |
Secondary
Persistent Reactions: Diazolidinyl Urea
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Persistent Reactions: Diazolidinyl Urea | 2 participants |
Secondary
Persistent Reactions: Epoxy Resin
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Persistent Reactions: Epoxy Resin | 1 participants |
Secondary
Persistent Reactions: Ethylenediamine Dihydrochloride
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Persistent Reactions: Ethylenediamine Dihydrochloride | 4 participants |
Secondary
Persistent Reactions: Formaldehyde
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Persistent Reactions: Formaldehyde | 1 participants |
Secondary
Persistent Reactions: Fragrance Mix
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Persistent Reactions: Fragrance Mix | 5 participants |
Secondary
Persistent Reactions: Imidazolidinyl Urea
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Persistent Reactions: Imidazolidinyl Urea | 0 participants |
Secondary
Persistent Reactions: Mercaptobenzothiazole
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Persistent Reactions: Mercaptobenzothiazole | 1 participants |
Secondary
Persistent Reactions: Mercapto Mix
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Persistent Reactions: Mercapto Mix | 1 participants |
Secondary
Persistent Reactions: Negative Control
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Persistent Reactions: Negative Control | 0 participants |
Secondary
Persistent Reactions: Neomycin Sulfate
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Persistent Reactions: Neomycin Sulfate | 5 participants |
Secondary
Persistent Reactions: Nickel Sulfate
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Persistent Reactions: Nickel Sulfate | 16 participants |
Secondary
Persistent Reactions: Paraben Mix
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Persistent Reactions: Paraben Mix | 1 participants |
Secondary
Persistent Reactions: Potassium Dichromate
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Persistent Reactions: Potassium Dichromate | 3 participants |
Secondary
Persistent Reactions: p-Phenylenediamine
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Persistent Reactions: p-Phenylenediamine | 0 participants |
Secondary
Persistent Reactions: P-tert Butylphenol Formadehyde Resin
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Persistent Reactions: P-tert Butylphenol Formadehyde Resin | 6 participants |
Secondary
Persistent Reactions: Quaternium-15
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Persistent Reactions: Quaternium-15 | 2 participants |
Secondary
Persistent Reactions: Quinoline Mix
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Persistent Reactions: Quinoline Mix | 0 participants |
Secondary
Persistent Reactions: Thimerosal
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Persistent Reactions: Thimerosal | 2 participants |
Secondary
Persistent Reactions: Thiuram Mix
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Persistent Reactions: Thiuram Mix | 0 participants |
Secondary
Persistent Reactions: Tixocortol-21-pivalate
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Persistent Reactions: Tixocortol-21-pivalate | 3 participants |
Secondary
Persistent Reactions: Wool Alcohol
Number of subjects with persistent reactions defined as positive reactions identified at visit 3 or 4 that are still present at the next visit.
Time frame: Visit 3: 3-4 days after patch application through Visit 4: 7 days after patch application and/or Visit 5 21 days after patch application
Population: Number of participants analyzed includes all subjects who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Persistent Reactions: Wool Alcohol | 6 participants |
Secondary
Subject Reported Itching and Burning
Subject reported itching/burning was scored according to the following descriptors; None, Weak, Moderate, Strong (not defined in protocol)
Time frame: Visit 2 (day 1) following to panel removal.
Population: All subjects who completed the study are included in the analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| All Subjects | Subject Reported Itching and Burning | Panel 2 Itching and Burning | Weak | 32 Participants |
| All Subjects | Subject Reported Itching and Burning | Panel 2 Itching and Burning | Moderate | 15 Participants |
| All Subjects | Subject Reported Itching and Burning | Panel 1 Itching and Burning | None | 33 Participants |
| All Subjects | Subject Reported Itching and Burning | Panel 1 Itching and Burning | Weak | 34 Participants |
| All Subjects | Subject Reported Itching and Burning | Panel 1 Itching and Burning | Moderate | 12 Participants |
| All Subjects | Subject Reported Itching and Burning | Panel 1 Itching and Burning | Strong | 21 Participants |
| All Subjects | Subject Reported Itching and Burning | Panel 2 Itching and Burning | None | 44 Participants |
| All Subjects | Subject Reported Itching and Burning | Panel 2 Itching and Burning | Strong | 9 Participants |
| All Subjects | Subject Reported Itching and Burning | Panel 3 Itching and Burning | None | 60 Participants |
| All Subjects | Subject Reported Itching and Burning | Panel 3 Itching and Burning | Weak | 23 Participants |
| All Subjects | Subject Reported Itching and Burning | Panel 3 Itching and Burning | Moderate | 5 Participants |
| All Subjects | Subject Reported Itching and Burning | Panel 3 Itching and Burning | Strong | 12 Participants |