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The purpose of this study is to determine optimal allergen dose as the lowest concentration eliciting positive reactions in 70-90% of subjects. Frequency of positive, negative, doubtful and irritant reactions, and concordance with a corresponding reference allergens will be captured.
This is a single-center, randomized study to compare the diagnostic performance and safety of ascending doses (0.10 mg/cm², 0.20 mg/cm² and 0.40 mg/cm²) of hydroxyisohexyl 3-cyclohexene carboxaldehyde (Lyral®) in 20 adult subjects with a past positive patch test to Lyral® or Fragrance Mix 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive reactions, Concordance with reference allergen | Experimental | Subjects were patch tested with an experimental allergen panel containing ascending doses of Lyral (0.10 mg/cm2, 0.20 mg/cm2 and 0.40 mg/cm2) and a negative control. A second panel containing 20 mg of 5% Lyral in petrolatum was applied for evaluation of concordance. The panels were worn for approximately 48 hours. Skin reactions were assessed at 3, 4 and 21 days following application. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lyral® | Biological | Alergen panel containing ascending doses of Lyral (0.10 mg/cm^2, 0.20 mg/cm^2 and 0.40 mg/cm^2) and negative control |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Positive Patch Test Responses | Subjects were patch tested with one experimental T.R.U.E. Test allergen panel containing 0.40 mg/cm^2, 0.20 mg/cm^2, and 0.10 mg/cm^2 of Lyral® and a negative control and a second panel containing the marketed reference allergen (20 mg of Lyral® 5%, in petrolatum). The panels were worn for approximately 48 hours. Skin reactions were assessed at 3, 4 and 21 days following application. Negative responses are graded no response, doubtful response (faint erythema, no infiltration), or irritant response (patchy erythema, no infiltration). Positive responses are graded 1+ (erythema, infiltration, discrete papules), 2+ (erythema infiltration, papules, discrete vesicles), or 3+ (coalescing vesicles, bullous reaction) | Patch test sites were evaluated at day 3 or 4, day 7 and day 21 following application. Results were assessed by the Investigator following the day 21 visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Tape Irritation, Itching and Burning | Tape irritation is graded on a 4 point scale: None (no tape irritation), Weak (faint to definite pink), Moderate (moderate erythema, definite redness) and Strong (severe erythema, very intense redness). Percentage of response will include weak, moderate and strong reactions. Itching and Burning are graded on a 4 point scale: None (no discomfort), Weak (minimal discomfort), Moderate (definite discomfort) and Strong (significantly bothersome, possible interference with sleep or daily activity). Percentage of response will include weak, moderate and strong responses. |
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Inclusion Criteria:
Males and females 18 years of age and older.
Clinical history of contact dermatitis and positive patch test (current or previous) to either Lyral® or Fragrance Mix 2; otherwise in good general health.
Unable to become pregnant or willing to use an acceptable method of contraception to prevent pregnancy if female of childbearing potential; Inability to become pregnant would include all male subjects and female subjects who are postmenopausal for at least 1 year, or surgically sterile- have had a hysterectomy, bilateral ovariectomy, uterine ablation or bilateral tubal ligation.
Acceptable methods of contraception include: 1) systemic birth control (the same type of birth control for at least 3 months prior to entering the study and continuation of this type of birth control throughout the study); 2) double barrier methods (condom with spermicide or diaphragm with spermicide); 3) intra uterine device; 4) vasectomized partner; or 5) abstinence from sexual intercourse.
Have read and signed the consent form and are able to fulfill the study requirements and make all required visits.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evy Paulsen, Md, PhD | Department of Dermatology and Allergy Centre Odense University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern Denmark Institute of Clinical Research | Odense | DK-5000 | Denmark |
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| ID | Title | Description |
|---|---|---|
| FG000 | Positive Reactions, Concordance With Reference Allergen | Subjects were patch tested with an experimental allergen panel containing ascending doses of Lyral (0.10 mg/cm^2, 0.20 mg/cm^2 and 0.40 mg/cm^2) Lyral® and a negative control. A second panel containing 20 mg of the marketed Lyral allergen, 5%, in petrolatum was applied for evaluation of concordance. The panels were worn for approximately 48 hours. Skin reactions were assessed at 3, 4 and 21 days following application. Lyral®: T.R.U.E. Test allergen panel containing ascending doses of Lyral (0.10 mg/cm^2, 0.20 mg/cm^2 and 0.40 mg/cm^2) and negative control |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | Positive Reactions, Concordance With Reference Allergen | Subjects were patch tested with an experimental allergen panel containing ascending doses of Lyral (0.10 mg/cm2, 0.20 mg/cm2 and 0.40 mg/cm2) and a negative control. A second panel containing 20 mg of 5%, in petrolatum was applied for evaluation of concordance. The panels were worn for approximately 48 hours. Skin reactions were assessed at 3, 4 and 21 days following application. Allergen panel containing ascending doses of Lyral (0.10 mg/cm2, 0.20 mg/cm2 and 0.40 mg/cm2) and negative control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Positive Patch Test Responses | Subjects were patch tested with one experimental T.R.U.E. Test allergen panel containing 0.40 mg/cm^2, 0.20 mg/cm^2, and 0.10 mg/cm^2 of Lyral® and a negative control and a second panel containing the marketed reference allergen (20 mg of Lyral® 5%, in petrolatum). The panels were worn for approximately 48 hours. Skin reactions were assessed at 3, 4 and 21 days following application. Negative responses are graded no response, doubtful response (faint erythema, no infiltration), or irritant response (patchy erythema, no infiltration). Positive responses are graded 1+ (erythema, infiltration, discrete papules), 2+ (erythema infiltration, papules, discrete vesicles), or 3+ (coalescing vesicles, bullous reaction) | Posted | Number | participants | Patch test sites were evaluated at day 3 or 4, day 7 and day 21 following application. Results were assessed by the Investigator following the day 21 visit. |
|
Days 2-21
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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 | Positive Reactions, Concordance With Reference Allergen | Subjects were patch tested with an experimental allergen panel containing all doses of Lyral (0.10 mg/cm^2, 0.20 mg/cm^2 and 0.40 mg/cm^2) Lyral® and a negative control. A second panel containing 20 mg of the marketed Lyral allergen, 5%, in petrolatum was applied for evaluation of concordance. It is not possible to discern specific dose relative to adverse events. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitus | Eye disorders | MedDRA (15.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathryn Shannon | Allerderm(dba) SmartPractice | 6022250595 | kshannon@smarthealth.com |
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| ID | Term |
|---|---|
| D003877 | Dermatitis, Contact |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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| ID | Term |
|---|---|
| C092244 | hydroxyisohexyl 3-cyclohexene carboxaldehyde |
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|
| Day 2: 48 hours after application |
| Number of Subjects Who Exhibit Late or Persistent Reactions | Late reactions initially occur at 7-21 days after application of the panels Persistent reactions appear at Day 2-4 and persist through Day 7-21 | Days 2-21 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects were patch tested with an experimental allergen panel containing ascending doses of Lyral (0.10 mg/cm^2, 0.20 mg/cm^2 and 0.40 mg/cm^2) Lyral® and a negative control. A second panel containing 20 mg of the marketed Lyral allergen, 5%, in petrolatum was applied for evaluation of concordance. The panels were worn for approximately 48 hours. Skin reactions were assessed at 3, 4 and 21 days following application. Lyral®: T.R.U.E. Test allergen panel containing ascending doses of Lyral (0.10 mg/cm^2, 0.20 mg/cm^2 and 0.40 mg/cm^2) and negative control |
|
|
|
| Secondary | Number of Subjects With Tape Irritation, Itching and Burning | Tape irritation is graded on a 4 point scale: None (no tape irritation), Weak (faint to definite pink), Moderate (moderate erythema, definite redness) and Strong (severe erythema, very intense redness). Percentage of response will include weak, moderate and strong reactions. Itching and Burning are graded on a 4 point scale: None (no discomfort), Weak (minimal discomfort), Moderate (definite discomfort) and Strong (significantly bothersome, possible interference with sleep or daily activity). Percentage of response will include weak, moderate and strong responses. | Posted | Number | participants | Day 2: 48 hours after application |
|
|
|
| Secondary | Number of Subjects Who Exhibit Late or Persistent Reactions | Late reactions initially occur at 7-21 days after application of the panels Persistent reactions appear at Day 2-4 and persist through Day 7-21 | Posted | Count of Participants | Participants | Days 2-21 |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 3 |
| 22 |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
| Tape Irritation: Strong |
|
| Itching: None |
|
| Itching: Weak |
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| Itching: Moderate |
|
| Itching: Strong |
|
| Burning: None |
|
| Burning: Weak |
|
| Burning: Moderate |
|
| Burning: Strong |
|
| Title | Measurements |
|---|---|
|
| 0.40 mg/cm^2 Persistent Reactions |
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| 0.20 mg/cm^2 Persistent Reactions |
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| 0.10 mg/cm^2 Persistent Reactions |
|