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 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
NCT ID:
NCT00821457
Eligibility Criteria:
Inclusion Criteria:
* Male and Female Caucasian patients aged 18-45 years who have provided written informed consent.
* A body mass index between 15 and 35 kg/m2 (calculated using Quetelet's index \[weight (kg)/height m2\]
* Patients with, in the opinion of the Investigator, clinically acceptable results for the laboratory tests specified in the trial protocol (see Section 6.4.2). All laboratory tests must be performed within 28 days of the first trial dose administration.
* Female patients of child bearing potential who are using a highly effective method(s) of contraception and agree to do so from at least the screening visit until one month after administration of the final study dose. For the purposes of the protocol, highly effective method(s) of contraception will be defined as consistently and correctly used implants, injectables, combined oral contraceptives, sexual abstinence or a vasectomised partner
* The scar to be treated is 2-6 months old at Day 0.
* The scar is linear.
* The scar to be treated is symmetrical in appearance around the mid-line.
* The scar to be treated is between 7cm and 20cm in length and a maximum of 1cm in width.
* The scar to be treated runs along a flat surface which is in the same focal plane and suitable for accurate medical photography.
Exclusion Criteria:
* Patients who on direct questioning and / or physical examination, have evidence of any past or present clinically significant medical condition that would impair wound healing including :
* Significant rheumatoid arthritis.
* Significant hepatic impairment (LFTs \>3 times upper limit of normal).
* Inadequately or uncontrolled congestive heart failure.
* Currently active malignancy or history of any malignancy in the 5 years prior to the screening visit.
* Immunosuppression or chemotherapy in the twelve months prior to the screening visit.
* A history of radiotherapy to the study scar area.
* Diabetes mellitus (unless controlled by diet and exercise alone).
* A bleeding disorder or current use of anti-thrombotic therapy (aspirin, ticlopidine and clopidogrel are permitted).
* Patients with a creatinine clearance (CLcr) of 80ml/min or less. Creatinine clearance will be determined from the serum creatinine level at pre-study screening using the following formula :
o CLcr = (140-age (years)) x weight(kg)/ 72 x serum creatinine (mg/dL) { x 0.85 for females }
* Patients with a skin disorder that is chronic or currently active and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial.
* Patients with a history of clinically relevant allergy, hypersensitivity, angioedema, or anaphylaxis.
* Patients with a progressive neurological condition including Parkinson's disease, Alzheimer's disease and uncontrolled epilepsy.
* Patients with a known history of chronic viral infection (Hepatitis, HIV) or ongoing active infection.
* Patients with bleeding disorders including haemophilia, purpura or thrombocytopenia or receiving anticoagulants (e.g. warfarin, coumadin).
* Patients with an ongoing psychiatric condition requiring treatment or psychosis (including depression with psychosis, bipolar disease and schizophrenia.
* Patients with a history of clinically significant hypersensitivity to any of the drugs, surgical markers or surgical dressings to be used in this trial.
* Patients who are taking, or have taken, any investigational drugs within 3 months prior to the screening visit.
* Patients undergoing investigations or changes in management for an existing medical condition.
* Female patients who are breast feeding, or intending to become pregnant or breast feed during the study period (subjects must be using adequate contraception and have a negative pregnancy test at screening).
* Female patients who have had any change in their oral contraceptive medication (if applicable) in the 2 months prior to screening, or anticipate any change during study participation
* In the opinion of the Investigator, a patient who is not likely to complete the trial for whatever reason.
* Patients with a history of substance abuse or dependency (a history of recreational use of cannabis is acceptable assuming a negative urine test for cannabis at screen. Patients who have had a history of alcohol abuse but have been dependency free for 12 months will still be eligible).
* Patients who on direct questioning and physical examination have a history or evidence of keloid scarring.
* Patients with additional scars less than 3cm away from the scar to be treated.
* The scar to be treated is a facial scar.
* Patients who are involved in ongoing litigation in connection with the scar to be treated.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00821457
Study Brief:
Protocol Section:
NCT00821457