None listed
Conditions
Interventions
Intervention1: 1. Santino Cool 2x
2. Basil Earth
3. Original (High Total Fatty Matter (TMF))
4. Amaze Original LUP
: Soap to be used on face twice daily for seven days
Control Intervention1: Not Appli
Sponsors
Reckitt Benckiser Health Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Subject able to give written informed consent and from whom written informed consent has been obtained. 2) Healthy male and female subjects between the ages of 18 and 55 years inclusive at the time of informal consent. 3) Subject with Fitzpatrick Scale Phototype III to V skin 4) Subjects who are able to understand the study, co-operate with the study procedures and prohibitions, and are able to attend all study assessments.
Exclusion criteria
Exclusion criteria: 1) Female subject who is pregnant (self-report), lactating, have given birth within the previous 3 months or are planning to become pregnant in the duration of the study. 2) Female subjects of childbearing potential who, for the duration of the study, are either unwilling or unable to take adequate contraceptive precautions or are unwilling to be sexually abstinent. 3) Subject with known skin disorders (acne, psoriasis, eczema, rosacea, or other). 4) Subjects with dry or sensitive skin on the face (interrogation of skin type by questionnaire and dermatologist assessment). 5) Subject with dryness or irritation on the face or hands at the screening. 6) Subject with known allergies to any of the test product ingredients. 7) Subject with excessive hair growth on the face that in opinion if the Investigator will hinder visual assessment of the test site. Subjects with freckles, beauty spots, birthmarks, or a tattoo at the test site. 8) Subject with a history of type 1 or type 2 diabetes. 9) Subject with peripheral vascular disease or poor blood circulation (self-reported). 10) Subject with a significant past medical history of the hepatic, renal, cardiac, pulmonary, digestive, haematological, endocrinological, neurological, locomotor, or psychiatric disease which, in the opinion of the investigator, would compromise the safety of the subject. 11) Subject with a history of skin tumours or malignant disease. 12) Subject whose skin has been excessively exposed to the sun or to UV rays during the previous month in the opinion of the Investigator. 13) Subject who is suffering from chronic asthma, a malfunction of the lymphatic system, or an autoimmune deficiency disease (e.g. lupus, thyroiditis). 14) Subject taking antihistamine or steroid preparations, any medication for the treatment of diabetes mellitus, immunosuppressive drugs, or any other medication which, in the opinion of the investigator, may affect the test results. 15) Subject who has a history of excessive drug or alcohol use (in line with national guidance) which will affect the test results in the opinion of the Investigator. 16) Subject with any conditions, which in the opinion of the investigator, may affect the results of the study. 17) Subject who has participated in any clinical study during the previous month or are currently participating in a separate clinical study. 18) Employee at the study site. 19) Any partner or first-degree relative of the subject who has a role in the study at the vendor site. 20) Subject unable in the opinion of the Investigator to comply fully with the study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the in use cutaneous compatibility of each of the four test formulations when used on the face for 7 daysTimepoint: An assessment of the Mean Irritation Index (M.I.I.) at 30 mins post initial use and after 7 days in-use. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Subject self-assessment of tolerance on Days 1-7 with use of SPQs. 2. Dermatologist Global assessment of tolerance at Day 7 for each Subject. 3. An overall assessment of the in-use tolerance for all subjects by the Dermatologist at the end of the study. 4. Prevalence of any adverse events. Timepoint: 1. Day 1 and Day 7 2. Day 7 3. Day 7 4. Day 1 and Day 7 | — |
Countries
India
Contacts
Public ContactMs Maheshvari Patel
Cliantha Research
Outcome results
None listed