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Sponsored by: |
Healthpoint |
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Information provided by: | Healthpoint |
ClinicalTrials.gov Identifier: | NCT00767676 |
Contact sensitization by patch applications.
Condition | Intervention | Phase |
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Healthy Volunteers |
Other: HP 828-101 |
Phase I |
Study Type: | Interventional |
Study Design: | Non-Randomized, Single Blind (Outcomes Assessor), Single Group Assignment, Safety Study |
Official Title: | Evaluation of the Contact Sensitization Potential of 828 Ointment in Normal Healthy Adults |
Enrollment: | 200 |
Study Start Date: | October 2008 |
Study Completion Date: | November 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1 |
Other: HP 828-101
Nine topical patch applications over 3 weeks, rest period of 2 weeks and challenge after 48 hours.
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Single site study that will evaluate the contact sensitization potential of 828 ointment by repetitive patch applications to the skin of normal, healthy volunteers.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
1. SUBJECTS 1.1 SUBJECT POPULATION
Subjects will be normal, healthy volunteers of both genders aged 18 to 65 years.
Inclusion Criteria:
Subjects must satisfy all of the following criteria:
Exclusion Criteria:
Subjects with any of the following conditions are not eligible for participation:
Responsible Party: | Healthpoint ( Inne Cargill, PhD ) |
Study ID Numbers: | 828-101-09-011 |
Study First Received: | October 4, 2008 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00767676 |
Health Authority: | United States: Food and Drug Administration |
Contact sensitization Healthy Adult Volunteers |
Healthy |