None listed
Conditions
Interventions
Intervention1: Rice ceramide – oral supplements: Subjects will be instructed to dissolve the contents of a sachet in water and drink once a day for 4 weeks.
Control Intervention1: NIL: NIL
Sponsors
Ichimaru Pharcos Co Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female adult subjects in general good health as determined from a recent medical history, general physical examination, dermatological assessment. 2. Subjects in the age group of 25-65 years both ages inclusive. 3. Subjects with skin phototype III to V, min 50% subjects need to be phototype III. 4. Subjects with close resemblance to the Thai population. 5. Subject presenting at least 1 well defined dark spot on the face. 6. Subjects free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face as determined by the dermatologist. 7. Subject who agrees not to use any other product or treatment or home remedy except the provided product on their face during the study period other than the test product. 8. Subjects who agree not to carry out bleaching or any other procedures including facial etc. on face during the study period. 9. Subjects who agree not to have direct and excessive sun exposure, not more than half an hour daily and during that time use of umbrella to cover face. 10. Subjects willing to give a voluntary written informed consent, photography release and agree to come for regular follow-up. 11. Subjects willing to abide by and comply with the study protocol.
Exclusion criteria
Exclusion criteria: 1. Subject with any other signs of significant local irritation or skin disease. 2. Subject currently taking any medication, which the Investigator believes may have an impact on the skin and study results. 3. Subject having clinically significant systemic or cutaneous disease, chronic illness or had major surgery in the last year. 4. Subjects undergoing any treatment of any skin condition on their face 5. Subjects not willing to discontinue other topical facial products. 6. Subject allergic or sensitive to bar, cleansing products, cosmetics, creams/lotions, artificial jewelery or anything else. 7. Subjects who are pregnant or nursing. 8. Subjects on any medical treatment either systemic or topical in the past 1 month or currently taking medication including food supplements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Improvement in wrinkles, fine lines and dark spots at different timepoints in comparison to the baseline using Antera and dermatological evaluations. 2. Improvement in skin hydration at all defined timepoints in comparison to the baseline using Corneometer. 3. Improvement in skin water barrier function at all defined timepoints in comparison to the baseline using TEWL. 4. Improvement in the skin color in comparison to baseline at all defined timepoints using Spectrophotometer. 5. Improvement in skin attributes in comparison to baseline at all defined timepoints using and in skin attributes using VISIA CR imaging.Timepoint: baseline, week 1, week 2, week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate dermatological safety and tolerability of the test product under regular (once daily) intake for 4 weeks.Timepoint: baseline, week 1, week 2, week 4 | — |
Countries
India
Contacts
Public ContactSudhanthiran S
MS Clinical Research Pvt. Ltd.
Outcome results
None listed