A Clinical Trial to Evaluate the Safety and Efficacy of a Moisturizer Body Lotion and a Lip Moist… (NCT04950374) | Clinical Trial Compass
WithdrawnNot Applicable
A Clinical Trial to Evaluate the Safety and Efficacy of a Moisturizer Body Lotion and a Lip Moisturizer in Adults of Atopic Dermatitis.
Stopped: Study halted prematurely, prior to enrollment of first participant due to change on study design.
0Started 2021-07-26
Plain-language summary
This study will test the safety and efficacy of 2 moisturizers: a body lotion and a lip moisturizer. For the moisturizer body lotion, the study aims to determine the tolerance of this product by the study population, and its effects on atopic dermatitis condition, skin hydration, skin barrier, skin microbiome and perceived efficacy. For the lip moisturizer, the study aims to determine the tolerance of this product by the same study population and its effects on the perceived efficacy. Participants will receive both products and use them at home for 21 +/- 2 days.
Who can participate
Age range
18 Years – 59 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:
* Fitzpatrick Skin Type I to VI;
* Subjects with mild to moderate atopic dermatitis according to the SCORAD index (mild global score (up to 24) and moderate global score (between 25 to 50), presenting dermatological lesions at the initial study visit;
* Generally in good health based on medical history reported by the subject;
* Able to read, write, speak and understand Portuguese;
* Person who signed the Consent for Photograph Release and Informed Consent Form;
* Person who agrees to change their leave on body and lip moisturizers to the products of this study, and agrees to use them throughout the test period;
* Intends to complete the study and is willing and able to follow all study instructions.
Exclusion Criteria:
* Subject who attends the Study Site, on the inclusion visit, with leave on moisturizer applied on the instrumental and microbiome evaluation areas;
* Present the need for systemic treatments (as in severe atopic dermatitis cases) such as the use of oral corticosteroids or other types of systemic treatments, as assessed by the Study Physician;
* Perform topical antimicrobial therapies (such as sodium hypochlorite bath or use of topical antibiotics);
* Perform phototherapy;
* Use of antimicrobial / antibacterial / anti germ soaps or other cosmetic and hygiene products;
* Subject who has used other leave on moisturizers in the test areas (body, face and lip), with the exception of investigational products, and/or who has changed their hygi…
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 of scores of erythema to 21 ± 2 days
Timeframe: 21 ± 2 days
2
Change from baseline of the scores of peeling to 21 ± 2 days
Timeframe: 21 ± 2 days
3
Change from baseline of the scores of blistering to 21 ± 2 days
Timeframe: 21 ± 2 days
4
Change from baseline of the scores to edema to 21 ± 2 days
Timeframe: 21 ± 2 days
5
Percentage of participants with Adverse Events through 21 ± 2 days
Timeframe: Up to 21 ± 2 days
6
Change from baseline of scores of erythema to 5 ± 1 days
Timeframe: 5 ± 1 days
7
Change from baseline of the scores of peeling to 5 ± 1 days