A Clinical Study to Assess the Safety and Effectiveness of Test Products in Mild to Moderate Atop… (NCT06687512) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Clinical Study to Assess the Safety and Effectiveness of Test Products in Mild to Moderate Atopic Dermatitis (AD) Patients.
44 participantsStarted 2024-11-20
Plain-language summary
This is an exploratory, proof-of-concept, double-blind, placebo-controlled, randomized, comparative, interventional, prospective, safety in-use tolerability and efficacy study of test products in patients with mild to moderate Atopic Dermatitis.
Who can participate
Age range
6 Years – 65 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:
* 1\) Age: For children: 6 years and above (both inclusive) at the time of parental consent/assent and For Adults: 18 to 65 years (both inclusive) at the time of consent.
2\) Sex: Healthy children (male or female) and adults (males and non-pregnant/non-lactating females) with mild to moderate atopic dermatitis.
3\) Subject's with TEWL \>15% and Moisture level \<20% at the time of screening. 4) Subject's with mild to moderate Atopic Dermatitis determined by Eczema Area and Severity Index (EASI) score with moderate erythema (redness: score 2) and mild scratch mark (scratching: score 1) will be enrolled into the study.
5\) Subject is diagnosed with mild to moderate atopic dermatitis with at least 1 active lesion that are accessible for instrumental measurements.
6\) Females of childbearing potential should have a negative urine pregnancy test at the time of screening visit.
7\) Subjects (adults and children) are generally in good general health as determined from a recent medical history, except for the atopic dermatitis.
8\) If subjects (adults and children) are using or taking any prescription or over the counter (OTC) medications prescribed by their physicians, they must be taking the medication for at least 4 weeks.
9\) Subject's and child's legal parent or guardian must agree to use the same brands and agree not to switch brands or variants of any skin care products during the study period.
10\) Subject's and child's legal parent…
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
To evaluate the effectiveness of the test products in terms of change in Dry Skin/Ichthyosis Area and Severity Index (DASI)
Timeframe: baseline before usage on Day 01 and after usage of the test products at T30 minutes on Day 01, Day 30 (±2 Days) and Day 60 (±2 Days)
2
To evaluate the effectiveness of the test products in terms of changes in SCORAD severity scoring,
Timeframe: before usage of the test products on Day 01 and after usage of test products at T30 mins on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).
3
To evaluate the effectiveness of the test products in terms of changes in Eczema Area and Severity Index
Timeframe: before usage of the test products on Day 01 and after usage of test products at T30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).
4
To evaluate the effectiveness of the test products in terms of changes in visual assessment of post inflammatory hyperpigmentation
Timeframe: before usage of the test products on Day 01 and after usage of test products at T30 minutes on Day 01, Day 30 (± 2 Days), Day 60 (± 2 Days).