None listed
Conditions
Interventions
Intervention1: Lutein 10 mg
Zeaxanthin 2 mg: 8 grams of granules should be reconstituted in 200 mL of water to prepare a beverage and consumed with breakfast,Duration:84 days
Intervention2: Lutein 20
Sponsors
Ingex Botanicals Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ambulatory, male and female subjects of 40-60 years age with a Body Mass Index (BMI) of 20 to 29 kg/m2. 2. Subjects considered as healthy by Principal Investigator through medical history and laboratory results during screening. 3. Subjects who are having 3-5 degrees wrinkles in the crow s-feet area, with global photodamage score between 3 and 6, and water content 170 or less on both left and right cheeks. 4. Fitzpatrick Skin Phototypes III to V 5. Subject free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face. 6. Subjects voluntarily agree to participate, sign written informed consent and comply with study protocol. 7. Subjects willing not to undergo Skincare therapy, Laser therapy, Botox/Filler, ETC during the study period. 8. Subjects willing to not to take food that could effect on skin condition and continue their normal diet during the study period 9. Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non-childbearing potential must be amenorrhoeic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy.
Exclusion criteria
Exclusion criteria: 1. Expectation of any surgery during the study period. 2. Subject with history of allergies to cosmetics pharmaceutical products or foods containing ingredients included in the study supplement. 3. Use of topical retinoids, any other anti-wrinkle steroid products and cosmetic products containing AHA BHA within the 3 months prior to initiation of the study. 4. Subjects who are using moisture-rich cosmetic products within the 2 Weeks prior to study initiation. 5. Subjects with uncontrolled Diabetes FPG greater than 126 mgdL and Hypertension Systolic greater than 140 mmHg and Diastolic greater than 90 mmHg. 6. Subjects with history of renal or liver impairment, any endocrine, inflammatory cardiovascular gastro-intestinal neurological psychiatric neoplastic or metabolic disease. 7. Subjects suffering from COPD or having history of any respiratory or breathing disorders. 8. Subjects with HIV Positive status. 9. Alcohol intake more than 2 standard drinks per day or use of recreational drugs such as cocaine methamphetamine marijuana etc. and smokers. 10. Participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit. 11. Clinically significant or abnormal laboratory results during screening. 12. Any condition judged by the investigator to be unsuitable for participation in the study. 13. Female subjects who are pregnant, breast feeding or planning to become pregnant during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in Skin hydration from baseline to visit 3 (Week 6) and visit 4 (Week 12). 2.Change in Elasticity from baseline to visit 3 (Week 6) and visit 4 (Week 12). 3.Change in Trans epidermal water loss (TEWL) from baseline to visit 3 (Week 6) and visit 4 (Week 12). 4.Change Erythema index (EI) and melanin index (MI) from baseline to visit 3 (Week 6) and visit 4 (Week 12). 5.Change in Skin collagen measurement from baseline to visit 3 (Week 6) and visit 4(Week 12). 6.Change in Serum Antioxidant levels (SOD & CAT) from baseline to visit 3 (Week 6) and visit 4(Week 12). 7.Change in Serum Lutein and Zeaxanthin levels from baseline to visit 4 (week 12). 8.Change in Skin Keratinocytes from baseline to visit 4 (week 12).Timepoint: Day 0, Day 42, Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in Ceramide, Fibrillin and GSH from baseline to visit 3 (Week 6) and visit 4 (Week 12). 2.Change in Participants degree of satisfaction (Questionnaire) from baseline to visit 3 (Week 6) and visit 4(Week 12). 3.Change in DLQI Questionnaire from baseline to visit 3 (Week 6) and visit 4(Week 12).Timepoint: Day 0, Day 42, Day 84. | — |
Countries
India
Contacts
Public ContactDr Ashok Godavarthi
Radiant Research Services Pvt Ltd.
Outcome results
None listed