Evaluation of the Safety and Tolerability of a Brightening Treatment Paired With a Skincare Regimen (NCT07501000) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the Safety and Tolerability of a Brightening Treatment Paired With a Skincare Regimen
United States11 participantsStarted 2024-10-07
Plain-language summary
A12-week single-center, open-label, clinical study is being conducted to assess the efficacy and tolerability of the Brightening Treatment paired with a skincare regimen on healthy female subjects aged 20-65 years with Fitzpatrick Skin Types I - VI and moderate global facial pigmentation due to sun exposure, blemishes, and/or procedures when applied by a clinician in a series of 4 sessions at 2-week intervals. The procedure in this clinical study will include the brightening treatment, retinol serum, and a post-procedure cream. The study visits include baseline, week 2, 6, and 12.
Who can participate
Age range
20 Years – 65 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
. Individuals in good general health (physical, mental, social well-being; not merely the absence of disease), based on medical history reported by the subject.
. Individuals of Female biological sex.
. Individuals between 20 to 65 years of age.
. Individuals with Fitzpatrick skin types I - VI
. Individuals of any race or ethnicity.
. Individuals with moderate global facial Hyperpigmentation (score of 3 for darkness, and heterogeneity, and a score of 3 to 4 for area on the PIHASI scale).
. Individuals with self-perceived facial pigmentation.
Exclusion criteria
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.
. Individuals currently participating in or has participated in any other clinical study involving the face at another research facility or doctor's office within the past one (1) month.
. Individuals with no self-perceived facial pigmentation.
. Individuals diagnosed with known allergies to facial skin care products, moisturizers, or sunscreens.
. Individuals who are nursing (breastfeeding), pregnant, or planning to become pregnant during the study according to subject self-report.
. Individuals who currently smoke or have smoked (cigarette, e-cigarettes, etc.) within the past 5 years.
. Individuals currently having or have a history of facial skin cancer within the past 5 years. Have or had cancer pertaining to any parts of the body and systems which in the opinion of the Investigator could interfere with the outcome of the study.
. Individuals currently having or having a history of cold sores (Herpes Simplex) on the face.