Effects of Topical SLPI on Skin Wounds

• Status: Completed
• Trial end date: 2003-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Dental and Craniofacial Research (NIDCR)
• Treatments: Anti-Inflammatory Agents; HIV Protease Inhibitors; Protease Inhibitors; Secretory Leukocyte Peptidase Inhibitor

Criteria

Healthy subjects will be used in the study to remove bias from associated pathology/comorbidity.

Only Caucasian patients will be included.

One group of male volunteers of 60-80 years of age will be used for the pilot study.

There will be two groups for the main study: one male and one female group (age-matched equivalent groups).

Females will be post-menopausal with the menarche at least 1 year previously and not taking hormone replacement therapy.

No patients infected with Hepatitis B, C, non A/B virus or HIV.

Pregnancy or lactating females will be excluded.

Diabetic patients will be excluded.

Patient must not be a smoker; or ex-smoker of greater than 5 per day for over one year.

Patients must not be on any regular medication, for example: oral/topical/intra-articular corticosteroids, NSAIDSs, immunosuppressives, chemotherapeutic agents, anti-hypertensives, vasodilators, anti-arthritic agents (gold, azathioprine), antibiotics, and insulin/biguanides/sulphonylureas.

Patients must not be taking oral contraceptive or HRT (oral or implant) (main study only).

Patients must not have a history of cardiovascular disease, malignancy, stroke, inflammatory bowel disease, Alzheimer's disease, or pulmonary fibrosis/sarcoid/CAPD.

Patients must not have presence of anemia, leukocytosis, bleeding disorder, or abnormal renal/liver function.

Patients with known keloid former or previous evidence of hypertrophic scarring will be excluded.

Patients with presence of skin disorders such as venous ulcers, psoriasis, eczema or lichen planus will be excluded.