Clinical Evaluation of Lyral® Dose Response Study

NCT02028182 | Completed Phase 2 Results

• 1 other identifier: 12 1PL 201
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Contact Dermatitis

Keywords

Patch Test; Allergy Testing; Contact dermatitis; Lyral allergen; Fragrance Mix allergen

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Positive Patch Test Responses

  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)

  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 (2)

• Number of Subjects With Tape Irritation, Itching and Burning

  Day 2: 48 hours after application

• Number of Subjects Who Exhibit Late or Persistent Reactions

  Days 2-21

Study Arms (1)

Positive reactions, Concordance with reference allergen

EXPERIMENTAL

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.

Biological: Lyral®

Interventions

Lyral® 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

Also known as: Lyral Allergen Panel (experimental)

Positive reactions, Concordance with reference allergen

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allerderm: lead

Study Sites (1)

University of Southern Denmark Institute of Clinical Research

Odense, DK-5000, Denmark

Location

MeSH Terms

Conditions

Dermatitis, Contact

Interventions

hydroxyisohexyl 3-cyclohexene carboxaldehyde

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Results Point of Contact

• Title: Kathryn Shannon
• Organization: Allerderm(dba) SmartPractice

kshannon@smarthealth.com

6022250595

Study Officials

• Evy Paulsen, Md, PhD

  Department of Dermatology and Allergy Centre Odense University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2014
• First Posted: January 7, 2014
• Study Start: February 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 28, 2023
• Results First Posted: August 24, 2020

Record last verified: 2014-01

Locations

DK (1)