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 @ 1:48 PM
Ignite Modification Date:
2025-12-24 @ 1:48 PM
NCT ID:
NCT00847795
Eligibility Criteria:
Inclusion Criteria:
* Clinically healthy, male and female subjects aged 60 years and over. All females will be at least 2 years post menopausal.
* Weight between 50 and 150kg or a body mass index within the permitted range for their height using Quetelet's index-weight (kg)/height²(m). The permitted index is between 15 - 35 kg/m2.
Exclusion Criteria:
* Subjects who on direct questioning and physical examination have a history or evidence of hypertrophic or keloid scarring or with tattoos or previous scars in the area to be biopsied.
* Subjects with a personal history of a bleeding disorder.
* Subjects with a skin disorder that is chronic or currently active and which the investigator considers will adversely affect the healing the acute wounds or involves the areas to be examined in this trial.
* Subjects with any clinically significant medical condition that would impair wound healing including renal, hepatic, haematological, neurological or immune disease.
* Subjects with a history of clinically significant drug hypersensitivity to lignocaine or allergy to surgical dressings to be used in this trial.
* Subjects with any clinically significant abnormality following review of pre trial laboratory data and physical examination (see above).
* Subjects who are taking, or have taken, any investigational drugs, long term oral, topical or inhaled corticosteroid therapy, hormone replacement therapy (HRT) or anti-coagulant drugs in the thirty days prior to Day 0.
* Subjects who have evidence of drug abuse.
* Subjects who are known to have or had serum hepatitis or who are carriers of the hepatitis B surface antigen or hepatitis C antibody. Subjects with previous vaccination against Hepatitis B are not excluded per se.
* Subjects who are known to have or had serum hepatitis or who are carriers of the hepatitis B core antibody and who show less than 10 units per litre of Anti-HBs.
* Subjects who have previously had a positive result to the test for HIV antibodies, or who admit to belonging to a high-risk group.
* In the opinion of the investigator, a subject who is not likely to complete the trial for what ever reason.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT00847795
Study Brief:
Protocol Section:
NCT00847795