A Clinical Study to Assess the Safety, In-use Tolerability of Test Product in Healthy Adult Subje… (NCT06489600) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Study to Assess the Safety, In-use Tolerability of Test Product in Healthy Adult Subjects With Dry and Sensitive Skin.
India27 participantsStarted 2024-12-19
Plain-language summary
This is open-label, interventional, prospective, safety in-use tolerability study of test product "No Rays, Thanks Mineral Sunscreen" in healthy adult human subjects with dry and sensitive skin.
Who can participate
Age range
18 Years – 55 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
. Age: 18 to 55 years (both inclusive) at the time of consent.
. Sex: Healthy male and non-pregnant/non-lactating females. (Preferably equal ratio of males and females)
. Females of childbearing potential must have a self-reported negative pregnancy test.
. Subject are generally in good health.
. Subject with dry and sensitive skins. (As per the dermatological evaluation).
. Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
. If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
. Subjects are willing to give written informed consent and are willing to come for regular follow up.
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.
What they're measuring
1
Change in local intolerance assessment for skin irritation using 4-point scoring scale where 0 indicate absent and 3 indicate severe.
Timeframe: On Day 01 at T15 minutes and on Day 15 (± 2 Days).
2
Change in local intolerance assessment for skin dryness using 4-point scoring scale where 0 indicate absent and 3 indicate severe.
Timeframe: On Day 01 at T15 minutes and on Day 15 (± 2 Days).
3
Change in local intolerance assessment for skin oedema using 4-point scoring scale where 0 indicate absent and 3 indicate severe.
Timeframe: On Day 01 at T15 minutes and on Day 15 (± 2 Days).
4
safety of the test product in terms of local intolerance assessment of irritation (Patient Global Assessment scale) where 0 indicate not at all and 10 indicate very severe.
Timeframe: On Day 01 at T15 minutes and on Day 15 (± 2 Days).
5
safety of the test product in terms of local intolerance assessment of dryness (Patient Global Assessment scale) where 0 indicate not at all and 10 indicate very severe.
Timeframe: On Day 01 at T15 minutes and on Day 15 (± 2 Days).
6
safety of the test product in terms of local intolerance assessment of oedema (Patient Global Assessment scale) where 0 indicate not at all and 10 indicate very severe.
. History of any dermatological condition of the skin disease.
. Subject with present condition of allergic response to any cosmetic product.
. Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy etc.) that might influence the outcome of the study.
. History of alcohol or drug addiction.
. The subject has clinically significant skin disease, which may contraindicate participation, including psoriasis, eczema, skin cancer or other skin pathology.
. Subjects having skin infections like bacterial, fungal, viral infections.
. The subject has skin irritation, open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the face that can interfere with the reading.
. Be wearing any facial makeup, including false eyelashes, on the day of the study visit.
Timeframe: On Day 01 at T15 minutes and on Day 15 (± 2 Days).