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NCT00353158 · ClinicalTrials.gov registry record · Phase 1
A Pilot of Pediatric/Adult Study of Gene Expression Profiling and Clinical Characterization of Phototoxicity
A Phase 1 study of Healthy Volunteers and Bacterial Infections, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- Completed
- Registry status
- Phase 1
- Development phase
- 62
- Enrollment target
- 1
- Study location
NCT00353158 is a Phase 1 study of Healthy Volunteers and Bacterial Infections that has completed, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The registered enrollment target is 62 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00353158, a Phase 1 study of Healthy Volunteers and Bacterial Infections, has completed, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 62 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will examine the phototoxicity, a reaction to light that is like exaggerated sunburn, which occurs in people who take medications such as voriconazole, a medication used to fight fungus. Sunscreens might protect the skin from the reaction. Although phototoxicity from voriconazole is not completely understood, it may be related to how that medication is metabolized in the liver by enzymes called cytochrome P450 enzymes-and mainly by one known as 2C19. A way to evaluate phototoxicity is through microarrays, which measure how much each gene is expressed in cells from tissues such as skin. Patients ages 8 and older who are scheduled to begin taking or who currently take voriconazole may be eligible for this study. Also, patients ages 18 to 45 in good health who have skin tone known as Type 2, which usually burns and tans only slightly following sun exposure, may be eligible. All patients will visit the Dermatology Clinic. They will complete two questionnaires, on medical history and medications, as well as the skin response to sunlight, and donate about 3 teaspoons of blood. Patients who are scheduled to take voriconazole will visit the clinic four times, that is, two visits 2 consecutive days before beginning the medication and two visits on 2 consecutive days after taking it for at least 7 days. Each visit will take 1 to 2 hours. Patients about to take voriconazole will have a blood test and undergo a physical exam of the skin test site, on the buttocks. Researchers will take photographs of the specific site and do tests to measure skin reaction to ultraviolet (UV) light. UV light will be shined on 15 small areas of the skin, each 1 x 1 centimeters. After 24 hours, any redness that occurs on the skin will be checked. Afterward, patients will begin taking voriconazole according to directions by the researchers. At 10 or more days later, patients will visit the clinic. Sunscreen will be applied and 1 hour later after administration of voriconazole, a blood s
Conditions Studied
Interventions
- DRUG Doxycycline
- DRUG Voriconazole
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2007-05-25 |
| Est. Completion | 2011-09-20 |
| Phase | Phase 1 |
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)93 total trials
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00353158
The ClinicalTrials.gov registry entry for NCT00353158 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (87% lower). The listed sponsor is National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Doxycycline is the first listed.
NCT00353158 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00353158 about?
NCT00353158 is a clinical study titled "A Pilot of Pediatric/Adult Study of Gene Expression Profiling and Clinical Characterization of Phototoxicity". This study will examine the phototoxicity, a reaction to light that is like exaggerated sunburn, which occurs in people who take medications such as voriconazole, a medication used to fight fungus. Sunscreens might protect the skin from the reaction. Although phototoxicity from voriconazole is not c...
What is the current status of trial NCT00353158?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2007-05-25. Estimated completion is 2011-09-20.
What conditions does trial NCT00353158 study?
This clinical trial studies the following conditions: Healthy Volunteers, Bacterial Infections, Fungal Infections.
What interventions are being tested in trial NCT00353158?
The interventions under investigation include: Doxycycline (DRUG), Voriconazole (DRUG).
Who is sponsoring clinical trial NCT00353158?
This trial is sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00353158 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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