Trial Assessing the Impact on Facial Skin Quality, Hydration, and Skin Barrier of Three (3) Hydra… (NCT05932732) | Clinical Trial Compass
CompletedPhase 4
Trial Assessing the Impact on Facial Skin Quality, Hydration, and Skin Barrier of Three (3) Hydrafacial Treatments in Adults of All Skin Types.
United States27 participantsStarted 2023-11-20
Plain-language summary
This is a phase IV, unblinded, open-label study assessing the impact on skin quality, hydration, and barrier of three (3) Hydrafacial treatments in healthy adults of Fitzpatrick Skin Types I \& II, III, IV, V \& VI, 30 to 55 years of age. Efficacy and subject satisfaction will be assessed, before and after three (3) HF treatments, in 6 patient cohorts, each cohort defined by FST I-VI.
Who can participate
Age range
30 Years – 55 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
. Healthy males and females of Fitzpatrick skin types I-VI 30-55 years of age.
. No known medical conditions that in the investigator's opinion may interfere with study participation.
. Agrees to abstain from starting a new skincare product for the duration of trial participation.
. Willingness to cooperate and participate by following study requirements.
. Individuals must sign an informed consent and photography consent.
Exclusion criteria
. History of any cancer excluding fully treated basal cell carcinoma or squamous cell carcinoma in situ in the treatment area.
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.
What they're measuring
1
Change in skin facial skin elasticity, wrinkles, roughness, fine lines, pigmentation, erythema, and pore size
. Presence of untreated precancerous lesions in the treatment area.
. Presence of sunburn, moderate to pronounced suntan, uneven skin tone, tattoos, scars or other disfiguration in the treatment area.
. Any cutaneous condition that may affect study adherence or ability to assess endpoints, as determined by the investigator, to include, but not limited to, uncontrolled psoriasis, atopic dermatitis, severe photodamage, and uncontrolled acne.
. Subject is pregnant, nursing, or planning to become pregnant.
. Significant past medical history of hepatic, hypertensive, renal, cardiac, pulmonary, digestive, hematological, neurological, or psychiatric disease, which in the opinion of the Investigator would compromise the safety of the subject.
. Currently participating in another clinical trial.