Clinical Evaluation of Lyral® Dose Response Study
Condition: Contact Dermatitis
MeSH terms: Dermatitis; Dermatitis, Contact
Intervention: Lyral®
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
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Patch Test; Allergy Testing; Contact dermatitis; Lyral allergen; Fragrance Mix allergen

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.
    

Eligibility 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) intra uterine device; 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.

        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.