Phase 2
N=22
Clinical Evaluation of Lyral® Dose Response Study
Contact Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT02028182 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Number of Participants With Positive Patch Test Responses — 14; 12; 11; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lyral® (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allerderm
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Positive Patch Test Responses |
14; 12; 11; 0; 6; 8 | — |
| SECONDARY Number of Subjects With Tape Irritation, Itching and Burning |
14; 8; 0; 0; 7; 10 | — |
| SECONDARY Number of Subjects Who Exhibit Late or Persistent Reactions |
1; 1; 2; 13; 10; 7 | — |
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
- 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.
Data sourced from ClinicalTrials.gov (NCT02028182). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.