- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005569
Effects of Topical SLPI on Skin Wounds
Effects of Topical Anti-Inflammatory Agents on Cutaneous Wound Healing
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institute of Dental and Craniofacial Research (NIDCR)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Publications and helpful links
General Publications
- Ashcroft GS, Dodsworth J, van Boxtel E, Tarnuzzer RW, Horan MA, Schultz GS, Ferguson MW. Estrogen accelerates cutaneous wound healing associated with an increase in TGF-beta1 levels. Nat Med. 1997 Nov;3(11):1209-15. doi: 10.1038/nm1197-1209.
- Ashcroft GS, Horan MA, Herrick SE, Tarnuzzer RW, Schultz GS, Ferguson MW. Age-related differences in the temporal and spatial regulation of matrix metalloproteinases (MMPs) in normal skin and acute cutaneous wounds of healthy humans. Cell Tissue Res. 1997 Dec;290(3):581-91. doi: 10.1007/s004410050963.
- Ashcroft GS, Herrick SE, Tarnuzzer RW, Horan MA, Schultz GS, Ferguson MW. Human ageing impairs injury-induced in vivo expression of tissue inhibitor of matrix metalloproteinases (TIMP)-1 and -2 proteins and mRNA. J Pathol. 1997 Oct;183(2):169-76. doi: 10.1002/(SICI)1096-9896(199710)183:23.0.CO;2-Q.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Wounds and Injuries
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Serine Proteinase Inhibitors
- Viral Protease Inhibitors
- Protease Inhibitors
- HIV Protease Inhibitors
- Secretory Leukocyte Peptidase Inhibitor
Other Study ID Numbers
- 000116
- 00-D-0116
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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