Clinical trial NCT02028182: Clinical Evaluation of Lyral® Dose Response Study
Official title: Clinical Evaluation of Hydroxyisohexyl 3-cyclohexene Carboxaldehyde (Lyral®) Dose Response Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Contact Dermatitis
Keywords: Patch Test
Allergy Testing
Contact dermatitis
Lyral allergen
Fragrance Mix allergen
Lead sponsor: Allerderm
Sponsor class: INDUSTRY
First posted: 2014-01-07
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Number of Participants With Positive Patch Test Responses
timeFrame: 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 outcomes:
measure: Number of Subjects With Tape Irritation, Itching and Burning
timeFrame: Day 2: 48 hours after application
measure: Number of Subjects Who Exhibit Late or Persistent Reactions
timeFrame: Days 2-21
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: University of Southern Denmark Institute of Clinical Research
Study officials:
affiliation: Department of Dermatology and Allergy Centre Odense University Hospital
name: Evy Paulsen, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References: