None listed
Conditions
Interventions
Intervention1: No Rays Thanks Mineral Sunscreen: Test product name: No Rays Thanks Mineral Sunscreen
Marketed By |Manufactured By: Kayura Effect LLP
dose: as required
dosage form: semi solid
Mode o
Sponsors
Kayura Effect LLP
Eligibility
Inclusion criteria
Inclusion criteria: 1)Age: 18 to 55 years (both inclusive) at the time of consent. 2)Sex: Healthy male and non-pregnant/non-lactating females. (Preferably equal ratio of males and females) 3)Females of childbearing potential must have a self-reported negative pregnancy test. 4)Subject are generally in good health. 5)Subject with dry and sensitive skins. (As per the dermatological evaluation). 6)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. 7)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. 8)Subjects are willing to give written informed consent and are willing to come for regular follow up. 9)Subjects who commit not to use medicated skincare products other than the test product for the entire duration of the study. 10)Subject who have not participated in a similar investigation in the past three months. 11)Willing to use test product throughout the study period.
Exclusion criteria
Exclusion criteria: 1)History of any dermatological condition of the skin disease. 2)Subject with present condition of allergic response to any cosmetic product. 3)Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy etc.) that might influence the outcome of the study. 4)History of alcohol or drug addiction. 5)The subject has clinically significant skin disease, which may contraindicate participation, including psoriasis, eczema, skin cancer or other skin pathology. 6)Subjects having skin infections like bacterial, fungal, viral infections. 7)The subject has skin irritation, open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the face that can interfere with the reading. 8)Be wearing any facial makeup, including false eyelashes, on the day of the study visit. 9)Subjects having hypersensitive skin. 10)Subjects using other marketed sun screen products during the study period. 11)Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion. 12)Pregnant or breastfeeding or planning to become pregnant during the study period. 13)History of chronic illness which may influence the cutaneous state. 14)Subjects participating in other similar cosmetics, devices or therapeutic trials or skincare products within the last four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety of the test product in terms of 1.Change in local intolerance assessment for irritation, dryness, Oedema after usage of test product on Day 01 at T15 mins and on Day 15 by the dermatologist. 2. Change in local intolerance assessment for irritation, dryness, Oedema after usage of test product on Day 01 at T15 mins and on Day 15 by the Patient Global Assessment Scale. Timepoint: on Day 1 after usage of test product at T20 mins and Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To assess the safety of the test product in terms of change in organoleptic parameters through the subject product perception from baseline before usage of test product on Day 01 and after usage of test product on Day 01 at T20 mins and on Day 15 by using Likert scoring scale.Timepoint: baseline on Day 1 and after usage of test product on Day 1 at T20 mins and Day 15 | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed