NCT00644917CompletedPhase 1
Clinical Evaluation of the Phototoxic Potential of Xenaderm Ointment
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Healthpoint
- Enrollment
- 38
- Primary Endpoint
- Skin Reaction Score
Study Overview
Brief Summary
The product is being tested to see if exposure to light causes toxic reactions on the skin.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy subjects
Exclusion Criteria
- •Under 18 years of age
Arms & Interventions
A
Experimental
Drug
Intervention: Xenaderm (Drug)
B
Placebo Comparator
Placebo comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Skin Reaction Score
Time Frame: 48 hours
Scores for phototoxic skin irritation were used to evaluate safety. In this study, irritation was graded using a scale that ranged from 0 (no reaction) to 7 (large vesiculo-bullous reaction) in whole units.
Secondary Outcomes
No secondary outcomes reported
Investigators
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