Phase
Condition
N/ATreatment
N/AClinical Study ID
Ages 25-55 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Healthy (by their own report) female participants aged between 35 and 55
Visual signs of aging of the face
Able and willing to complete all study assessments and to be followed for the fullcourse of the study.
Able to read, write and follow instructions in English.
Able and willing to provide informed consent.
Exclusion
Exclusion Criteria:
Pregnant women (or pregnancy within last 3 months).
Inadequate precaution or procedure to prevent pregnancy (women of child- bearingpotential only).
Individuals who have any implanted medical devices (pacemaker, pump, catheter, etc.)
Current or history of a medical condition that would contraindicate treatment with theproduct, such as epilepsy, hernia, abdominal ulcer, diabetes, or other conditionswhich, in the opinion of the Investigator, would place the participant at risk.
A current skin disease of any type at the test site (e.g. acne, eczema, psoriasis,burns, abrasions, etc.)
Heavy alcohol consumption in the opinion of the investigator.
A fever in the last 12 hours prior to the first application of the test device.
History of heart disease.
History of stroke.
History of malignant disease.
Insulin dependent diabetes.
Concurrent medication likely to affect the response to the test article or confuse theresults of the study (e.g. routine high dose use of any drugs that may artificiallyaffect skin tone).
Individuals who are currently participating in any other clinical. investigation, orwho have participated in a study with the same indication within 1 year.
Principal investigator for this study, or member of study staff.
Individuals who have had facial surgery.
Individuals who use BOTOX. (The latter two exclusions were applied because of thepossibility of an altered anatomical or physiological background which may haveinterfered with the effectiveness of the treatment).
Study Design
Study Description
Connect with a study center
Bio-Medical Research, Ltd.
Galway, County Galway
IrelandSite Not Available
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