A Study to Assess Safety and Improvement in Skin Barrier After Using 2 Facial Sunscreens in Adult… (NCT06243627) | Clinical Trial Compass
CompletedNot Applicable
A Study to Assess Safety and Improvement in Skin Barrier After Using 2 Facial Sunscreens in Adults With Sensitive Skin
Brazil35 participantsStarted 2023-09-27
Plain-language summary
The purpose of this trial is to evaluate 1) the dermatological tolerability of 2 facial sunscreens after 21 (+2) days of use under normal conditions on the half face by adult subjects with sensitive skin, 2) Compare the efficacy of investigational products (IPs) after 21 (+2) days of use in adult subjects with sensitive skin, under dermatological supervision through the following evaluations: the transepidermal water loss in the nasolabial region; the sensory perception of the subjects using the sensory perception questionnaire, after 21 (+2) days of use under normal conditions; the sensitivity of the subjects' skin after the first application of each product using a questionnaire on the perception of signs of discomfort.
Who can participate
Age range
18 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:
* Participants vaccinated against coronavirus disease 2019 (COVID-19)
* Participants of any gender
* Participants of any ethnicities according to Brazilian Institute of Geography and Statistics (IBGE) criteria
* Phototype II to IV according to Fitzpatrick's classification
* Participants - in good health based on medical history reported by the subject
* Participants presenting intact skin on the face, with the exception of clinical signs characteristic of sensitive skin
* Participants who declare themselves as having sensitive skin (according to the Institute's sensitive skin questionnaire, completed in the recruitment phase and reconfirmed by the physician on the day of inclusion)
* Able to read, write, speak and understand Portuguese (able to read and understand the documents delivered and what is explained to them)
* Participants who agree to maintain their cosmetic habits during the study period
* Participants who agree to maintain their cosmetic habits during the study period
* Participant who signed the Informed Consent Document (ICD)
* Agreement to adhere to the procedures and requirements of the study and to attend the Site on the day(s) and time(s) determined for the assessments
* Participant that intend to complete the study and is willing and able to follow all study instructions
Exclusion Criteria:
* Participants that have had allergies or adverse reactions to common topical skincare products, including sunscreens, medications, or other prod…
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 From Baseline in Dermatological Tolerability
Timeframe: Baseline (Day 1), Day 21
2
Change From Baseline in Skin Barrier Integrity
Timeframe: Baseline (Day 1), Day 21
3
Number of Participants With Sensory Perception as Assessed by Sensory Perception Questionnaire
Timeframe: At Day 21
4
Number of Participants With Skin Sensitivity as Assessed by Discomfort Questionnaire