A study to evaluate the efficacy of the oral supplement in providing various skin benefits in healthy female subjects
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Ichimaru Pharcos Co Ltd.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- 1. Improvement in wrinkles, fine lines and dark spots at different timepoints in
Overview
Brief Summary
The aim of the study is to determine the efficacy of the test product (oral supplement) in providing skin benefits. Subjects will be screened and enrolled based on inclusion and exclusion criteria. Dermatological and instrumental assessments to evaluate skin colour, skin tone, fine lines and wrinkles, skin hydration and water barrier will be conducted at baseline, week 1, week 2 and week 4 time points.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 25.00 Year(s) to 65.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Female adult subjects in general good health as determined from a recent medical history, general physical examination, dermatological assessment.
- •Subjects in the age group of 25-65 years both ages inclusive.
- •Subjects with skin phototype III to V, min 50% subjects need to be phototype III.
- •Subjects with close resemblance to the Thai population.
- •Subject presenting at least 1 well defined dark spot on the face.
- •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.
- •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.
- •Subjects who agree not to carry out bleaching or any other procedures including facial etc.
- •on face during the study period.
- •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.
Exclusion Criteria
- •Subject with any other signs of significant local irritation or skin disease.
- •Subject currently taking any medication, which the Investigator believes may have an impact on the skin and study results.
- •Subject having clinically significant systemic or cutaneous disease, chronic illness or had major surgery in the last year.
- •Subjects undergoing any treatment of any skin condition on their face
- •Subjects not willing to discontinue other topical facial products.
- •Subject allergic or sensitive to bar, cleansing products, cosmetics, creams/lotions, artificial jewelery or anything else.
- •Subjects who are pregnant or nursing.
- •Subjects on any medical treatment either systemic or topical in the past 1 month or currently taking medication including food supplements.
Outcomes
Primary Outcomes
1. Improvement in wrinkles, fine lines and dark spots at different timepoints in
Time Frame: baseline, week 1, week 2, week 4
comparison to the baseline using Antera and dermatological evaluations.
Time Frame: baseline, week 1, week 2, week 4
2. Improvement in skin hydration at all defined timepoints in comparison to
Time Frame: baseline, week 1, week 2, week 4
the baseline using Corneometer.
Time Frame: baseline, week 1, week 2, week 4
3. Improvement in skin water barrier function at all defined timepoints
Time Frame: baseline, week 1, week 2, week 4
in comparison to the baseline using TEWL.
Time Frame: baseline, week 1, week 2, week 4
4. Improvement in the skin color in comparison to baseline at all defined timepoints using Spectrophotometer.
Time Frame: baseline, week 1, week 2, week 4
5. Improvement in skin attributes in comparison to baseline at all defined timepoints using and in skin attributes using VISIA CR imaging.
Time Frame: baseline, week 1, week 2, week 4
Secondary Outcomes
- To evaluate dermatological safety and tolerability of the test product under(regular (once daily) intake for 4 weeks.)
Investigators
Dr Roshni Rai
MS Clinical Research Pvt. Ltd.