Allergic Contact Dermatitis Clinical Trial
Official title:
Clinical Evaluation of Bacitracin. A Phase II Dose-Response Study
Verified date | August 2005 |
Source | Mekos Laboratories AS |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to establish a concentration of a bacitracin-patch for diagnosing allergic contact dermatitis.
Status | Completed |
Enrollment | 20 |
Est. completion date | July 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Positive bacitracin patch test within the latest 5 years. - Age greater than or equal to 18 years. - Signed informed consent. Exclusion Criteria: - Topical treatment with corticosteroids or immunosuppressives during the latest 7 days on the test area or near the test area. - Systemic treatment with corticosteroids or immunosuppressives during the latest 7 days. - Treatment with ultraviolet (UV)-light during the latest 3 weeks. - Widespread active dermatitis or dermatitis on test area. - Breast-feeding or pregnancy. Females of childbearing potential must demonstrate a negative pregnancy test before inclusion in the study. - Subjects not able to cooperate. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Dermatological Clinic (Joseph Fowler MD) | Louisville | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Mekos Laboratories AS |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Skin reaction to the patch test after 72-96 hours and after 7 days | |||
Secondary | Evaluation of safety including late and persistent responses | |||
Secondary | Evaluation day 3/4, day 7 and day 21 |
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