A Phase 4 Clinical Study to Investigate the Effectiveness and Safety of Skin Resurfacing (NCT07214272) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Phase 4 Clinical Study to Investigate the Effectiveness and Safety of Skin Resurfacing
United States49 participantsStarted 2025-10-17
Plain-language summary
This study is a prospective, post-marketing (Phase 4) non-registrational single-arm, open-label, multicenter study.
Who can participate
Age range
21 Years – 60 Years
Sex
ALL
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
. Male or female.
. 21 to 60 years of age.
. Written informed consent must be obtained prior to any study procedures.
. Presence of one or more of the following in the treatment area(s):
. Photodamage as determined by investigator using a Modified Griffith's Scale (score of 3 to 7 in overall photodamage on the 9-point scale)
. Mild-to-moderate rhytids (e.g., periorbital crow's feet) as determined by investigator using a Modified Griffith's Scale (score of 3 to 6 on the 9-point scale).
. Mild-to-severe dyschromia, including lentigos or solar lentigines as determined by investigator using the Modified Griffith's Scale (score of 3 to 9 on the 9-point scale).
. Ability to read, understand, and sign the informed consent form
Exclusion criteria
. Pregnant, breastfeeding, or planning to become pregnant during the study.
. History of any type of allergic reaction to topical anesthetics.
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.
. Localized infection in the treatment area or systemic infection within the last 1 month prior to or at any time during the study.
. Presence of melasma, rosacea, significant actinic keratoses, or other significant skin conditions in the target treatment zone.
. Presence of skin cancer, infection, cold sore, open wounds, burns, psoriasis, or active dermatitis of any kind (atopic, contact, significant seborrheic dermatitis) in the target treatment zone.
. Presence of skin conditions that, in the judgement of the investigator, would increase the risk of study participation or treatment.
. Predisposition to keloid formation or excessive scarring.
. Diagnosis of a condition that may compromise the immune system, such as: HIV, lupus, and/or scleroderma.