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:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT00736593
Eligibility Criteria:
Inclusion Criteria:
1. Healthy male or female subjects.
2. Fair skinned (Fitzpatrick Classification Level I - III).
3. Aged between 18 and 40 years inclusive.
4. Subjects who are able to comply with all study procedures, including follow-up assessment visits.
5. Subjects who are willing and able to give written informed consent to take part in the study.
Exclusion Criteria:
1. Subjects who have pigmented skin due to an increased susceptibility to hypertrophic and keloid scarring (Fitzpatrick Classification Level IV - VI).
2. Subjects who are known hypertrophic or keloid scar formers.
3. Subjects who smoke.
4. Subjects with a body mass index of greater than 30 kg/m2.
5. Subjects with bleeding disorders or taking anti-coagulants.
6. Subjects with any other skin lesion sites or a chronic or currently active skin disorder, which would adversely affect the healing of the acute wounds or which involve the areas to be examined in this study.
7. Subjects taking or who have taken prescribed drugs in the 30 days prior to Day 0, in particular, topical or systemic steroids, anti-inflammatories, anti-coagulants, anti-proliferative drugs, or antibiotics.
8. Subjects who regularly take aspirin, ginseng, gilboa, Alka Seltzer or any other over-the-counter medicine or complimentary health product that can affect the blood clotting process.
9. Subjects with a history of clinically relevant allergies.
10. Subjects with tattoos, scars or abrasions at the site to be studied.
11. Subjects with any clinically significant abnormality following review of pre-study laboratory data and physical examination.
12. Subjects showing evidence of drug abuse.
13. Subjects with any clinically significant mental illness in the opinion of the Investigator.
14. Females who are currently pregnant or breast-feeding. Females of child-bearing potential must commit to consistent and correct use of an acceptable method of birth control, as defined the protocol.
15. Subjects who have a past or present disease, which as judged by the Investigator may affect the safety of the subject or the outcome of the study.
16. Subjects who have participated in a clinical study within the 30 days prior to Day 0.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT00736593
Study Brief:
Protocol Section:
NCT00736593