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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT03625167
Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteers and/or with stable chronic condition (e.g. controlled hypertension)
* Female,
* 65 to 85 years,
* Caucasian,
* Phototype I to III according to the Fitzpatrick classification,
* Body Mass Index between 20 and 28 kg/m2,
* Non-smoker of at least one year,
* Absence of skin diseases or scars in the skin area of interest,
* Absence of tattoos in the skin area of interest,
* Able to give written informed consent,
* Willing and able to fulfill the study requirements
Exclusion Criteria:
* Known or suspected defect of healing,
* Diabetes mellitus
* Any acute or chronic pathology that may interfere with the trial conduct, from investigator point of view,
* Acute or chronic wounds in the skin area of interest,
* Any skin affection which may interfere with the trial assessment, like urticaria,, psoriasis or scar on investigational areas,
* Medical history of skin cancer,
* History or establishment of diabetes or pre-diabetes,
* Any hyper-sensibility to one of the compounds of the investigational product,
* Any regular treatment which may affect the blood coagulation and hemostasis (anticoagulant medications, NSAID, etc.) before the suction blister induction (Visit 3 and Visit 5), one NSAID to treat headache within four days is allowed
* Any physical treatment (like laser or surgery) on the arms within the last 6 months,
* Use of topical or systemic treatment on the investigational areas within the past 4 weeks (topical hyaluronan, anti-inflammatory drugs, corticoids, retinoids, vitamin C, etc.) that would interfere with assessment and/or investigational treatments,
* Allergy to band-aid or to metals (such as nickel),
* UV sessions or strong sun exposure of the arms during the study period,
* Subject who cannot be contacted easily in case of necessity,
* Current participation in any other clinical study
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
65 Years
Maximum Age:
85 Years
Study:
NCT03625167
Study Brief:
Protocol Section:
NCT03625167