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Back To Vidyya Clinical Trial: Effects Of Topical Anti-Inflammatory Agents On Cutaneous Wound Healing

Patients Interested In Slpi Can Participate In This Study To Evaluate The Effects Of SLPI On Skin Wound Healing

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.

Sponsoring Institute:
National Institute of Dental And Craniofacial Research (NIDCR)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): American Indian or Alaskan Native


Asian/Pacific Islander

Black (Not of Hispanic Origin)


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

Caucasian only.

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 infection with Hepatitis B, C, non A/B virus or HIV.

No pregnancy or lactating females.

Must not be diabetic.

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

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.

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

No history of cardiovascular disease, malignancy, stroke, inflammatory bowel disease, Alzheimer's disease, or pulmonary fibrosis/sarcoid/CAPD.

No presence of anemia, leukocytosis, bleeding disorder, or abnormal renal/liver function.

No known keloid former or previous evidence of hypertrophic scarring.

No presence of skin disorders such as venous ulcers, psoriasis, eczema or lichen planus.

Special Instructions: Currently Not Provided
Disease Category:
Skin and Subcutaneous Tissue
Recruitment Keywords:
Healthy Volunteer
Investigational Drug(s):
SLPI (Secretory Leukocyte Protease Inhibitor)
Investigational Device(s):

Patient Recruitment and Public Liaison Office, CC.
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Long Distance Calls: 1-800-411-1222
Fax: (301) 480-9793

Ashcroft. 1997. Estrogen accelerates cutaneous wound healing associated with an increase in TGF-beta 1 levels, Nat Med, Vol. 3, p. 1209

Ashcroft. 1997. 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, Vol. 290, p. 581

Ashcroft. 1997. Human aging impairs injury-induced in vivo expression of tissue inhibitor of matrix metalloproteinases (TIMP)-1 and -2 proteins and mRNA, J Pathol, Vol. 183, p. 169

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Editor: Susan K. Boyer, RN
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