HealthyPhase 1NCT00005569
Effects of Topical SLPI on Skin Wounds
A Phase 1 study testing SLPI (Secretory Leukocyte Protease Inhibitor) in people with Healthy and Wound Healing, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy, Wound Healing
- What is being tested?
- SLPI (Secretory Leukocyte Protease Inhibitor)
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2000to Jul 2003
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, Maryland, 20892
About this study
Official title: 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:
Read more
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.
Read the detailed description
The proposed clinical trial will evaluate the efficacy and safety of topically-applied Secretory Leukocyte Protease Inhibitor (SLPI) peptide as a treatment for impaired wound healing states in 60-80 year old subjects who are at greatest risk of delayed wound healing. Administration of the drug topically should result in reduced elastase activity and inflammation, leading to accelerated matrix deposition and wound healing. Subjects will be randomly allocated to one of four possible groups: topical administration of SLPI or placebo (wounds excised at day 7 post-wounding) or topical administration of SLPI or placebo (wounds excised at day 50 post-wounding). The dose of SLPI will be determined in a dose-finding pilot study prior to the main study. Initial 4mm punch biopsies will be made in both upper inner arms (two per arm), followed by topical administration of SLPI or placebo. The wounds will be left to heal and all four wounds excised at either day 7 (for 50% of the volunteers) or day 50 post-wounding (for the other 50% of volunteers). The incidence of side-effects, and the rate of healing will be determined at these time-points. Successful demonstration of an enhanced therapeutic effect may provide a basis for the development of strategies to accelerate wound healing in those situations where it is comprised, such as with age and in chronic non-healing wounds.
- Conditions
- Healthy, Wound Healing
- Being tested
- SLPI (Secretory Leukocyte Protease Inhibitor)
- Keywords
- Elastase, Inflammation, Age, Gender, Cytokine, Healthy Volunteer
- Medical subject headings
- Inflammation, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLPI (Secretory Leukocyte Protease Inhibitor)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2000 (estimated)
- Study startApr 2000
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005569
- Sponsor's protocol ID
- 000116
- Other IDs
- 00-D-0116
- Status last verified
- Jul 2003
- First submitted
- 22 Apr 2000
- Last updated
- 4 Mar 2008
- Results posted
- No
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.
PubMed 9359694Ashcroft 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.
PubMed 9369533Ashcroft 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.
PubMed 9390029
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Topical Anti-Inflammatory Agents on Cutaneous Wound Healing
- ClinicalTrials.gov ID
- NCT00005569
- Acronym / sponsor ID
- 000116
- Conditions
- Healthy, Wound Healing
- Keywords
- Elastase, Inflammation, Age, Gender, Cytokine, Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)US National Institutes of Health
- Study start
- Apr 2000
- Study completion
- Jul 2003
- First posted
- 24 Apr 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The proposed clinical trial will evaluate the efficacy and safety of topically-applied Secretory Leukocyte Protease Inhibitor (SLPI) peptide as a treatment for impaired wound healing states in 60-80 year old subjects who are at greatest risk of delayed wound healing. Administration of the drug topically should result in reduced elastase activity and inflammation, leading to accelerated matrix deposition and wound healing. Subjects will be randomly allocated to one of four possible groups: topical administration of SLPI or placebo (wounds excised at day 7 post-wounding) or topical administration of SLPI or placebo (wounds excised at day 50 post-wounding). The dose of SLPI will be determined in a dose-finding pilot study prior to the main study. Initial 4mm punch biopsies will be made in both upper inner arms (two per arm), followed by topical administration of SLPI or placebo. The wounds will be left to heal and all four wounds excised at either day 7 (for 50% of the volunteers) or day 50 post-wounding (for the other 50% of volunteers). The incidence of side-effects, and the rate of healing will be determined at these time-points. Successful demonstration of an enhanced therapeutic effect may provide a basis for the development of strategies to accelerate wound healing in those situations where it is comprised, such as with age and in chronic non-healing wounds.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SLPI (Secretory Leukocyte Protease Inhibitor) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 9359694Ashcroft 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.
- Background: PubMed 9369533Ashcroft 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.
- Background: PubMed 9390029Ashcroft 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SLPI (Secretory Leukocyte Protease Inhibitor) in people with Healthy and Wound Healing, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005569, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.