Back to resultsClinical Evaluation of Lyral® Dose Response Study
Primary Purpose
Contact Dermatitis
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Lyral®
Sponsored by
About this trial
This is an interventional diagnostic trial for Contact Dermatitis focused on measuring Patch Test, Allergy Testing, Contact dermatitis, Lyral allergen, Fragrance Mix allergen
Eligibility Criteria
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:
- Lactation or pregnancy, determined by urine pregnancy test (UPT) for females of childbearing potential. UPT must be conducted prior to patch placement.
- Treatment with topical corticosteroids on or near the test area during the previous 7 days.
- Treatment with systemic corticosteroids or immunosuppressives during the previous 7 days. (Inhaled treatments are permitted.)
- 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.
- Participation in another clinical study involving an investigational drug, treatment or device currently or within the previous 3 weeks.
- Unable to comply with activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity).
- Unable or unwilling to comply with multiple return visits.
Sites / Locations
- University of Southern Denmark Institute of Clinical Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Positive reactions, Concordance with reference allergen
Arm Description
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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02028182
Brief Title
Clinical Evaluation of Lyral® Dose Response Study
Official Title
Clinical Evaluation of Hydroxyisohexyl 3-cyclohexene Carboxaldehyde (Lyral®) Dose Response Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allerderm
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contact Dermatitis
Keywords
Patch Test, Allergy Testing, Contact dermatitis, Lyral allergen, Fragrance Mix allergen
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Positive reactions, Concordance with reference allergen
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Lyral®
Other Intervention Name(s)
Lyral Allergen Panel (experimental)
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Participants With Positive Patch Test Responses
Description
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)
Time Frame
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.
Secondary Outcome Measure Information:
Title
Number of Subjects With Tape Irritation, Itching and Burning
Description
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.
Time Frame
Day 2: 48 hours after application
Title
Number of Subjects Who Exhibit Late or Persistent Reactions
Description
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
Time Frame
Days 2-21
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Lactation or pregnancy, determined by urine pregnancy test (UPT) for females of childbearing potential. UPT must be conducted prior to patch placement.
Treatment with topical corticosteroids on or near the test area during the previous 7 days.
Treatment with systemic corticosteroids or immunosuppressives during the previous 7 days. (Inhaled treatments are permitted.)
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.
Participation in another clinical study involving an investigational drug, treatment or device currently or within the previous 3 weeks.
Unable to comply with activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity).
Unable or unwilling to comply with multiple return visits.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evy Paulsen, Md, PhD
Organizational Affiliation
Department of Dermatology and Allergy Centre Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern Denmark Institute of Clinical Research
City
Odense
ZIP/Postal Code
DK-5000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of Lyral® Dose Response Study
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