Clinical Evaluation of Lyral® Dose Response Study

Phase 2

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Positive reactions, Concordance with reference allergen	Lyral®	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Positive Patch Test Responses	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.	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

Name	Time	Method
Number of Subjects With Tape Irritation, Itching and Burning	Day 2: 48 hours after application	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	Days 2-21	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