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NCT00005569 · ClinicalTrials.gov registry record · Phase 1
Effects of Topical SLPI on Skin Wounds
A Phase 1 study, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT00005569 is a Phase 1 study that has completed, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 60 participants.
The verdict
NCT00005569, a Phase 1 study, has completed, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
This study will evaluate the effects of a protein called secretory leukocyte protease inhibitor (SLPI), on skin wound healing. Produced naturally by the body, SLPI modifies levels of elastase, a substance that breaks down the skin. Older people are at greater risk of impaired wound healing, with increased elastase activity and inflammation. In addition, men heal more slowly than women. Delayed healing is associated with infection and pain and can lead to the development of chronic non-healing skin wounds. Healthy men and women between 60 and 80 years old who wish to participate in this study will have a brief history and physical evaluation to determine their eligibility. Those enrolled will be randomly assigned to receive a gel form of SLPI applied topically (on the skin surface) to a skin wound or a placebo (a look-alike gel with no active ingredient). Participants will undergo the following procedures: First visit - The skin will be numbed with a local anesthetic and two small (4 mm) wounds (about the size of a pencil eraser) made in each upper arm. The drug or placebo will be applied to the wound and gauze placed over it. Two blood samples (20 ml and 7 ml) will be drawn an hour apart to determine blood levels of SLPI. Second visit - The day after the first visit, the wound dressing will be removed and the participant will be evaluated for pain at the wound site, allergic reactions or infection. A blood sample (7 ml) will be taken. Third visit - The wounds will be examined and photographed to evaluate healing. In addition, the strength of the wound may be assessed by means of a vacuum system placed on the skin. (This may cause a tingling sensation over the wound.) A piece of all four wounds will be removed after the skin has been numbed and a dressing applied. Fourth visit - The wounds will be examined for healing and the dressing removed.
Interventions
- DRUG SLPI (Secretory Leukocyte Protease Inhibitor)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2000-04 |
| Est. Completion | 2003-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00005569
The ClinicalTrials.gov registry entry for NCT00005569 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SLPI (Secretory Leukocyte Protease Inhibitor) is the first listed.
NCT00005569 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00005569 about?
NCT00005569 is a clinical study titled "Effects of Topical SLPI on Skin Wounds". This study will evaluate the effects of a protein called secretory leukocyte protease inhibitor (SLPI), on skin wound healing. Produced naturally by the body, SLPI modifies levels of elastase, a substance that breaks down the skin. Older people are at greater risk of impaired wound healing, with inc...
What is the current status of trial NCT00005569?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2000-04. Estimated completion is 2003-07.
What interventions are being tested in trial NCT00005569?
The interventions under investigation include: SLPI (Secretory Leukocyte Protease Inhibitor) (DRUG).
Who is sponsoring clinical trial NCT00005569?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.
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