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 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
NCT ID:
NCT01321268
Eligibility Criteria:
Inclusion Criteria:
* Healthy female volunteers
* Age between 18 and 45 years at Day 01 of the study
* Body mass index (BMI) from 18.5 -24.9
* All Fitzpatrick skin types
* CSS score of at least 6
* Normal eating habits (no vegetarians or vegans)
* Written informed consent
Exclusion Criteria:
* Menopause and pre-menopause
* Smoking
* Pregnant women or women intending to become pregnant during study
* Lactation period
* Any kind of dermatological conditions
* Vegetarians or vegans
* Any kind of hepatitis, including any alteration in transaminases
* Use of illicit drugs
* Other surgical or internal diseases e.g. a metabolic or endocrine disease that may affect the outcome of the study (e.g. diabetes, liver diseases, kidney disorders) or having a history of medical or surgical events that may significantly affect the study outcome including any cardiovascular disease, skin disease, hypertension (\>160/95 mm Hg at repeated measurements)
* Existence of scars and/or pigmentation in measurement areas (thighs and buttocks), which can influence study measurements
* Participation in any other clinical trial including blood sampling and/or administration or substances up to 30 days before Day 01 of this study
* Any prior aesthetic surgery (Liposuction, Subcision®), 3 months before the study, that may interfere with results
* Any other prior anti-cellulite treatment or body measures treatment, 30 days prior to the study
* Participation in any other non-invasive clinical trial up to 30 days before Day 01 of this study, including blood sampling
* Recent blood or plasmapherese donation (less than 1 month prior to Day 01 of the study)
* Under medical treatment for a skin disease in the past and/or present with a therapy, which may influence the results of the study (systemic steroids or antibiotics, local steroids or topical immunomodulators during the last 3 months
* Use of sun beds or self-tanning products or sun exposure for one month before and during study
* Not willing to accept information-transfer concerning participation in the study, or information regarding his/her health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner
* Subjects intending to initiate any intensive sports
* Every other condition that the investigator might consider to involve a risk for the study subject.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01321268
Study Brief:
Protocol Section:
NCT01321268