Dermatitis, Contact
Conditions
Keywords
Bioequivalence, Thimerosal, Fragrance Mix, PVP formulation, Contact dermatitis
Brief summary
Open, prospective, multi-center study to evaluate the bioequivalence of povidone (PVP) formulations of 2 T.R.U.E. TEST allergens: fragrance mix and thimerosal.
Detailed description
Bioequivalence will be determined in 40 adult subjects (20 per allergen), who have a clinical history of contact dermatitis and have tested positive to fragrance mix or thimerosal.
Interventions
BIOLOGICALTRUE Test allergens Fragrance Mix and Thimerosol
* Thimerosal, 0.008 mg/cm2 in hydroxypropylcellulose * Thimerosal, 0.008 mg/cm2 in polyvinylpyrrolidone * Fragrance mix, 0.43 mg/cm2 in hydroxypropylcellulose with β-cyclodextrin * Fragrance mix, 0.43 mg/cm2 in polyvinylpyrrolidone with β-cyclodextrin Patches are placed at day one and removed 48 hours. The duration of the study lasts 21 days. However, the subject is only exposed the the study allergen for 48 hours.
Sponsors
Allerderm
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Current or previous symptoms and/or history consistent with allergic contact dermatitis, and positive patch test (within the past 5 years) to fragrance mix AND/OR thimerosal. * All subjects must be adults (18 years of age or older) and otherwise in good health. * Pre-menopausal female subjects must consent to a urine pregnancy test; results must be negative for study inclusion. * Informed consent must be signed and understood by each subject, and consistent with all institutional, local and national regulations.
Exclusion criteria
* Subjects unable to meet inclusion requirements. * Women who are breastfeeding or pregnant. * Topical treatment during the last 7 days with corticosteroids or other immunosuppressive agents on or near the test area. * Systemic treatment during the last 7 days with corticosteroids (equivalent to \> 10 mg prednisone) or other immunosuppressive agents. * Treatment with ultraviolet (UV) light (including tanning) during the previous 3 weeks. * Acute dermatitis outbreak or dermatitis on or near the test area on the back. * Subjects unable to comply with patch test study requirements including multiple return visits and activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity). * Subject participation in clinical trials of investigational drugs, treatments, or devices, other than T.R.U.E. TEST, during this study or 3 weeks prior to inclusion in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analysis of Bioequivalence: Concordance | Up to 21 days | Percent agreement between T.R.U.E. Test allergen in PVP vs HPC is based on a positive test response during at least one post application visit |
| Agreement Between TRUE Test Allergen and Reference Allergen | Up to 21 days | Sensitivity: Agreement between positive results for the test and reference allergen Specificity: Agreement between negative results for the test and reference allergen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Irritation, Adhesion, Itching/Burning | Visit 2: 48 hours after patch application | Frequency of tape-induced irritation at the test site, incomplete panel adhesion and subject-reported sensations of itching or burning. |
| Frequency of Late and Persistent Reactions | Day 2 (48 hours after application) through Day 21 | Late reactions occur 7-10 days after patch application Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application |
Countries
United States
Participant flow
Recruitment details
The study was conducted at 4 centers in the United States. The first subject was enrolled on Jan 2 2008 and the study completed on Dec 12 2008.
Pre-assignment details
No subject was excluded from the trial following enrollment but before assignment to a group.
Participants by arm
| Arm | Count |
|---|---|
| Sensitive Subjects Subjects with a clinical history and positive patch test (current or previous) to either fragrance mix or thimerosal. Study subjects must be otherwise healthy and fulfill entry criteria. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Sensitive Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants |
| Age, Continuous | 51.4 years STANDARD_DEVIATION 16.72 |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 50 |
| serious Total, serious adverse events | 1 / 50 |
Outcome results
Primary
Agreement Between TRUE Test Allergen and Reference Allergen
Sensitivity: Agreement between positive results for the test and reference allergen Specificity: Agreement between negative results for the test and reference allergen
Time frame: Up to 21 days
Population: The data from all enrolled subjects was analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fragrance Mix | Agreement Between TRUE Test Allergen and Reference Allergen | 40.9 percentage of agreement |
| Thimerosol | Agreement Between TRUE Test Allergen and Reference Allergen | 59.1 percentage of agreement |
| Sensitivity: Thimerosal in HPC | Agreement Between TRUE Test Allergen and Reference Allergen | 61.5 percentage of agreement |
| Sensitivity: Thimerosol in PVP | Agreement Between TRUE Test Allergen and Reference Allergen | 65.4 percentage of agreement |
| Specificity: Fragrance Mix in HPC | Agreement Between TRUE Test Allergen and Reference Allergen | 92.9 percentage of agreement |
| Specificity: Fragrance Mix in PVP | Agreement Between TRUE Test Allergen and Reference Allergen | 100 percentage of agreement |
| Specificity: Thimerosal in HPC | Agreement Between TRUE Test Allergen and Reference Allergen | 100 percentage of agreement |
| Specificity: Thimerosal in PVP | Agreement Between TRUE Test Allergen and Reference Allergen | 100 percentage of agreement |
Primary
Analysis of Bioequivalence: Concordance
Percent agreement between T.R.U.E. Test allergen in PVP vs HPC is based on a positive test response during at least one post application visit
Time frame: Up to 21 days
Population: The data from 50 subjects enrolled in the study was analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fragrance Mix | Analysis of Bioequivalence: Concordance | 76 percentage of agreement |
| Thimerosol | Analysis of Bioequivalence: Concordance | 98.0 percentage of agreement |
Secondary
Frequency of Late and Persistent Reactions
Late reactions occur 7-10 days after patch application Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application
Time frame: Day 2 (48 hours after application) through Day 21
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fragrance Mix | Frequency of Late and Persistent Reactions | 0 percentage of subjects with reactions |
| Thimerosol | Frequency of Late and Persistent Reactions | 0 percentage of subjects with reactions |
| Sensitivity: Thimerosal in HPC | Frequency of Late and Persistent Reactions | 0 percentage of subjects with reactions |
| Sensitivity: Thimerosol in PVP | Frequency of Late and Persistent Reactions | 0 percentage of subjects with reactions |
| Specificity: Fragrance Mix in HPC | Frequency of Late and Persistent Reactions | 0 percentage of subjects with reactions |
| Specificity: Fragrance Mix in PVP | Frequency of Late and Persistent Reactions | 0 percentage of subjects with reactions |
| Specificity: Thimerosal in HPC | Frequency of Late and Persistent Reactions | 4 percentage of subjects with reactions |
| Specificity: Thimerosal in PVP | Frequency of Late and Persistent Reactions | 4 percentage of subjects with reactions |
Secondary
Irritation, Adhesion, Itching/Burning
Frequency of tape-induced irritation at the test site, incomplete panel adhesion and subject-reported sensations of itching or burning.
Time frame: Visit 2: 48 hours after patch application
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fragrance Mix | Irritation, Adhesion, Itching/Burning | 28 percentage of participants |
| Thimerosol | Irritation, Adhesion, Itching/Burning | 24 percentage of participants |
| Sensitivity: Thimerosal in HPC | Irritation, Adhesion, Itching/Burning | 20 percentage of participants |
| Sensitivity: Thimerosol in PVP | Irritation, Adhesion, Itching/Burning | 46 percentage of participants |