yral Dose Response Study

Phase 1

• Conditions: Diagnosis of Allergic Contact Dermatitis; MedDRA version: 16.0Level: LLTClassification code 10056265Term: Allergic contact dermatitisSystem Organ Class: 100000004858; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2012-004257-81-DK
• Lead Sponsor: SmartPractice

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-15
• Last Update Posted: 17 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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) IUD; 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified