Clinical Case Study Evaluating the Efficacy and Tolerability of a Topical Facial Treatment on Hea… (NCT06633731) | Clinical Trial Compass
CompletedNot Applicable
Clinical Case Study Evaluating the Efficacy and Tolerability of a Topical Facial Treatment on Healthy Females with Fitzpatrick Skin Types V and VI
United States11 participantsStarted 2023-04-24
Plain-language summary
This single-center, open-label, clinical case trial was conducted to evaluate the efficacy and tolerability of a topical facial treatment when applied by a license esthetician in clinic in a series of 3 sessions with 1 month intervals on healthy women with Fitzpatrick Skin Types V and VI and mild to moderate global facial radiance, skin smoothness, and overall appearance. The treatment will include an topical facial treatment, biocellulose mask, and post-procedure cream. Furthermore subjects followed a 12 week skincare regimen consisting of a gentle cleanser, bland moisturizer, and bland sunscreen. Eleven (11) healthy female subjects completed the clinical study.
Who can participate
Age range
45 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 with Fitzpatrick Skin Type V and VI
* Individuals with mild to moderate global facial radiance, skin smoothness, and overall appearance (Score 2 - 6 on a 10-point modified Griffiths scale).
* Individuals willing to undergo a washout period of 3 days.
Exclusion Criteria:
* Individuals who are nursing (breastfeeding), pregnant, or planning to become pregnant during the study.
* Individuals currently having or having a history of cold sores (Herpes Simplex) on the face.
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 Investigator Clinical Efficacy Grading versus Baseline
Timeframe: 12 weeks
2
Lack of Significant Change in Investigator Tolerability Parameters versus Baseline
Timeframe: 12 weeks
3
Lack of Significant Change in Subjective Tolerability versus Baseline