Eligibility Module

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Eligibility Module

The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.

Eligibility Module path is as follows:

Study -> Protocol Section -> Eligibility Module

Eligibility Module

Ignite Creation Date: 2025-12-24 @ 11:02 PM
Ignite Modification Date: 2025-12-24 @ 11:02 PM
NCT ID: NCT00005569
Eligibility 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.
Healthy Volunteers: True
Sex: ALL
Study: NCT00005569
Study Brief:
Protocol Section: NCT00005569