Clinical Evaluation of Lyral® Dose Response Study

NCT ID: NCT02028182

Last Updated: 2023-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-06-30

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.

Conditions

Contact Dermatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Positive reactions, Concordance with reference allergen

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.

Group Type: EXPERIMENTAL

Lyral®

Intervention Type: BIOLOGICAL

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

Interventions

Lyral®

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

Intervention Type: BIOLOGICAL

Other Intervention Names

Lyral Allergen Panel (experimental)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allerderm

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Evy Paulsen, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology and Allergy Centre Odense University Hospital

Locations

University of Southern Denmark Institute of Clinical Research

Odense, , Denmark

Countries

Denmark

Other Identifiers

12 1PL 201

Identifier Type: -

Identifier Source: org_study_id