Diagnosis of Allergic Contact Dermatitis MedDRA version: 16.0 Level: LLT Classification code 10056265 Term: Allergic contact dermatitis System Organ Class: 100000004858
Conditions
Interventions
Product Name: Hydroxyisohexyl 3-cyclohexene carboxaldehyde (Lyral®)
Pharmaceutical Form: Cutaneous patch
Sponsors
SmartPractice
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females 18 years of age and older. 2. Clinical history of contact dermatitis and positive patch test (current or previous) to either Lyral® or Fragrance Mix 2; otherwise in good general health. 3. 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) IUD; 4) vasectomized partner; or 5) abstinence from sexual intercourse. 4. Have read and signed the consent form and are able to fulfill the study requirements and make all required visits. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 1. Lactation or pregnancy, determined by urine pregnancy test (UPT) for females of childbearing potential. UPT must be conducted prior to patch placement. 2. Treatment with topical corticosteroids on or near the test area during the previous 7 days. 3. Treatment with systemic corticosteroids or immunosuppressives during the previous 7 days. (Inhaled treatments are permitted.) 4. Treatment with ultraviolet (UV) light, including tanning, during the previous 3 weeks. 5. Acute dermatitis outbreak or dermatitis on or near the test area on the back. 6. Participation in another clinical study involving an investigational drug, treatment or device currently or within the previous 3 weeks. 7. Unable to comply with activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity). 8. Unable or unwilling to comply with multiple return visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the diagnostic performance and safety of a fragrance allergen proposed for inclusion in a T.R.U.E. Test Panel. Specifically, we propose a single-center, double-blind, randomized study comparing the diagnostic performance (primary) and safety (secondary) of ascending doses of Lyral® in 20 adult subjects who have a clinical history of contact dermatitis and have tested positive (current or previous patch test) to Lyral® or Fragrance Mix 2. To ascertain the optimal test allergen dose by determining the lowest concentration eliciting either +1 or +2 positive reactions in 70-90% of sensitive subjects; frequency of positive, negative, doubtful and irritant reactions for each allergen and concentration; and overall concordance and discordance as compared to the reference petrolatum allergens. ;Secondary Objective: To evaluate the frequency of irritation, late/persistent reactions, tape reactions, subject-reported itching or burning, and adverse events for each allergen dose.;Primary end point(s): To ascertain the optimal test allergen dose by determining the lowest concentration eliciting either +1 or +2 positive reactions in 70-90% of sensitive subjects; frequency of positive, negative, doubtful and irritant reactions for each allergen and concentration; and overall concordance and discordance as compared to the reference petrolatum allergens. ;Timepoint(s) of evaluation of this end point: All patch test panels will be removed after two days and test site skin reactions will be evaluated at least four times. The chosen evaluation times are consistent with generally accepted patch test guidelines and are designed to prevent missed late reactions and false negatives. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate the frequency of irritation, late/persistent reactions, tape reactions, subject-reported itching or burning, and adverse events for each allergen dose.;Timepoint(s) of evaluation of this end point: Irritation will be evaluated on Day 2, 20 minutes following patch removal. Late and/or persistent reactions are reported on Days 7(+1) and 21(±2). Subjects will be asked about itching and burning at patch removal and about changes in medications or medical condition at each visit. | — |
Countries
Denmark
Contacts
Public ContactKim Sullivan
SmartPractice
Outcome results
None listed