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 range18 Years – 55 Years
SexALL
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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
✕. History of any dermatological condition of the skin disease.
✕. Subject with present condition of allergic response to any cosmetic product.
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.
Timeframe: On Day 01 at T15 minutes and on Day 15 (± 2 Days).
. 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.