Treatment of Periorbital and Perioral Wrinkles With the Applications of the Iluminage Diode Laser (NCT01813760) | Clinical Trial Compass
CompletedNot Applicable
Treatment of Periorbital and Perioral Wrinkles With the Applications of the Iluminage Diode Laser
United States60 participantsStarted 2012-11
Plain-language summary
The Diode laser system is being used in this marketing study for the treatment of wrinkles around the eyes and mouth.
Who can participate
Age range
35 Years – 60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects who are healthy females between 35 and 60 years of age.
. Subjects who have Fitzpatrick skin type I-VI
. Subjects who have provided written and verbal informed consent
. Subjects who are willing and able to comply with study instructions and to return to the clinic for required visits and have photographs of their face taken
. Subjects who have perioral and periorbital wrinkles, as deemed appropriate by the Investigator or his designees
Exclusion criteria
. Subjects who currently use or have used in the prior 30 days any skin products that contain alpha hydroxy acids (AHA) e.g. glycolic, lactic, citric, or mendelic acid containing products or retinol/tretinoin containing products or exfoliating washes, masks or scrubs or other micro-dermabrasion skin care products. on the laser application areas
. Subjects who are unwilling to maintain their daily skin care regimen for the duration of the study,
. Subjects who have any skin pathology or condition that could interfere with the evaluation i.e. personal or family history of skin cancer, rosacea and/or requires the use of interfering topical or systemic therapies.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Subjects with synthetic or metal implants or permanent cosmetic tattoos in the test areas
. Subjects who have a history of abnormal scarring, e.g. keloids or have significant scarring in the areas to be treated
. Subjects with bleeding disorders or taking anticoagulation medications, including heavy use of aspirin
. Subjects who have participated in any clinical investigation involving the face within the 30 days prior to the first planned laser application or subjects who plan to participate in concomitant facial studies during this trial
. Subjects, who are pregnant, were pregnant or gave birth in the last 3 months, are currently breast feeding, or might become pregnant during the course of the study